Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-31 @ 1:01 AM
Study NCT ID:
NCT05559203
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2022-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
danceSing Care Evaluation: Testing the Feasibility
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.c.whittaker@stir.ac.uk', 'phone': '0178646', 'title': 'Prof Anna C. Whittaker', 'phoneExt': '7816', 'organization': 'University of Stirling'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'fall resulting in serious injury/hospitalisation', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Participants' Programme Adherence as % Sessions Attended Out of the Possible Maximum Number of Sessions Delivered Per Care Home Aggregated as % Across All Care Homes.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}, {'units': 'Delivered Sessions', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Will be evaluated after completion of the 12-week intervention period', 'description': "The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators. Individual participants' adherence is calculated as the number of sessions they individually attended out of the possible number of sessions available to them in their care home. This is reported as the percentage of attended sessions per person per care home out of those delivered averaged per care home then aggregated across all care homes.", 'unitOfMeasure': 'Delivered Sessions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Delivered Sessions', 'denomUnitsSelected': 'Delivered Sessions', 'populationDescription': 'calculates the number of sessions attended on average out of the possible maximum number of sessions delivered'}, {'type': 'PRIMARY', 'title': 'Number of Sessions Delivered, Assessed by Attendance Files', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}, {'units': 'Delivered Sessions', 'counts': [{'value': '336', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Will be evaluated after completion after the completion of the 12-week intervention period', 'description': "The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators.", 'unitOfMeasure': 'Delivered Sessions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Delivered Sessions', 'denomUnitsSelected': 'Delivered Sessions', 'populationDescription': 'Adherence across all carehomes allocated to the intervention, 7 delivered the intervention. Number of sessions delivered out of the recommended 48, then averaged across all 7 care homes.'}, {'type': 'PRIMARY', 'title': 'Acceptability of the Intervention Assessed by Focus Groups - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'qualitative themes', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm Trial - Intervention Group n = 47 Participants Were Allocated the Intervention', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'title': 'Adherence - participation and class size', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Delivery challenges with intervention', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Intervention Effects', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Modifications', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Future Refinements', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 month after completion after the completion of the 12-week intervention period', 'description': 'Investigators will conduct focus groups with the activity coordinators to assess acceptability of the intervention. Guide questions included:\n\nDid you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff?', 'unitOfMeasure': 'qualitative themes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'qualitative themes', 'denomUnitsSelected': 'qualitative themes', 'populationDescription': 'Five core themes emerged from 2 focus groups with 5 activity coordinators (care staff) across 2 focus groups. Exemplar quotes are given in the publication from this study.'}, {'type': 'PRIMARY', 'title': 'Acceptability of the Intervention Assessed by Interviews - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}, {'units': 'qualitative themes', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'title': 'Adherence', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Delivery challenges - Motivation and engagement', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Modifications', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Intervention Effects', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Future Implementation', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 month after completion after the completion of the 12-week intervention period', 'description': 'Investigators will conduct focus groups/interviews with residents to assess acceptability of the intervention. Guide questions included:\n\nDid you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff?', 'unitOfMeasure': 'qualitative themes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'qualitative themes', 'denomUnitsSelected': 'qualitative themes', 'populationDescription': '4 residents in 4 semi-structured interviews. Exemplar quotes are in the publication of the study.'}, {'type': 'SECONDARY', 'title': 'Change in Fear of Falling Between Baseline and Within One Month of Completing the Intervention Using the Falls Efficacy Scale - International (Short Form)(FES-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.556', 'groupId': 'OG000', 'lowerLimit': '-4.199', 'upperLimit': '3.088'}]}]}], 'analyses': [{'pValue': '.752', 'groupIds': ['OG000'], 'groupDescription': 'Feasibility study so no power calculation. N = 18 with baseline and follow-up data.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'paired sample', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 18 participants retained capacity to continue to consent and capacity to complete follow-up measures. Outcomes are mean difference from baseline to post-intervention.'}, {'type': 'SECONDARY', 'title': "Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of the Completion of the Intervention Using The Dartmouth COOP Charts", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.167', 'groupId': 'OG000', 'lowerLimit': '-.664', 'upperLimit': '2.998'}]}]}], 'analyses': [{'pValue': '.197', 'groupIds': ['OG000'], 'groupDescription': 'Feasibility study so no power calculation. N = 18 with baseline and follow-up data.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'Change in participant\'s Activities of daily living and health-related quality of life from baseline to within one month of the completion of the intervention using The Dartmouth COOP which has 5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 with pre- and post-intervention data. Mean difference measure.'}, {'type': 'SECONDARY', 'title': "Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of Completing the Intervention Using EQ-5D-3L", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '.278', 'groupId': 'OG000', 'lowerLimit': '-.714', 'upperLimit': '1.270'}]}]}], 'analyses': [{'pValue': '.562', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': "The EQ-5D-3L descriptive system comprises the following five questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has a 3-point scale for rating it: no problems, some problems, and extreme problems (1-3). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are then combined to describe the patient's health state, with a higher TOTAL score describing a worse outcome. The range for total score is 5-15.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 with pre- and post-intervention data. Mean difference measure between their TOTAL score at baseline and post-intervention.'}, {'type': 'SECONDARY', 'title': "Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Hospital Anxiety and Depression Scale (HADS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2.111', 'groupId': 'OG000', 'lowerLimit': '.373', 'upperLimit': '3.850'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.303', 'upperLimit': '4.697'}]}]}], 'analyses': [{'pValue': '.020', 'groupIds': ['OG000'], 'groupDescription': 'Anxiety subscale', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}, {'pValue': '.002', 'groupIds': ['OG000'], 'groupDescription': 'Depression subscale', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \\>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. No total score is reported. Anxiety and Depression sub-scale totals are calculated separately by summing responses to the applicable 7 items each. The range for each sub-scale is 0-21. A higher score indicates a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 with pre- and post-intervention data. Mean difference measure. For anxiety and depression separately.'}, {'type': 'SECONDARY', 'title': "Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Perceived Stress Scale (PSS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.167', 'groupId': 'OG000', 'lowerLimit': '.318', 'upperLimit': '8.016'}]}]}], 'analyses': [{'pValue': '.036', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 with pre- and post-intervention data. Mean difference measure.'}, {'type': 'SECONDARY', 'title': "Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Brief UCLA Loneliness Scale (ULS-6)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.667', 'groupId': 'OG000', 'lowerLimit': '.067', 'upperLimit': '3.267'}]}]}], 'analyses': [{'pValue': '.042', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'Using a 4-point rating scale (1= never; 4 = always), participants answer 6 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?". The Brief UCLA Loneliness scale is summed across items to give one total score. The range for total score is 6-24. A higher score indicates worse loneliness, i.e. a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 with pre- and post-intervention data. Mean difference measure.'}, {'type': 'SECONDARY', 'title': "Change in Participant's Sleep Satisfaction From Baseline to Within One Month of Completing the Intervention Using the National Sleep Foundation's Sleep Satisfaction Tool (SST)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.667', 'groupId': 'OG000', 'lowerLimit': '-9.174', 'upperLimit': '-4.159'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': "9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction. The SST scale is summed across items to give one total score. The range for total score is 9-36.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 with pre- and post-intervention data. Mean difference measure.'}, {'type': 'SECONDARY', 'title': "Change in Participant's Appetite From Baseline to Within One Month of Completing the Intervention Using the Simplified Nutritional Appetite Questionnaire (SNAQ)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'classes': [{'categories': [{'measurements': [{'value': '.167', 'groupId': 'OG000', 'lowerLimit': '-1.078', 'upperLimit': '1.411'}]}]}], 'analyses': [{'pValue': '.781', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': '0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'This is used for limited frailty testing, a self-assessment nutritional screening tool that predicts weight loss, scoring 1 (very poor) to 4 (very good) on appetite-related topics.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 with pre- and post-intervention data. Mean difference measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm Trial - Intervention Group n = 47 Participants Were Allocated the Intervention', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '47'}]}, {'type': 'Completed Intervention', 'comment': 'The review considers the units to be care homes not participants, I have changed this so it matches the adherence outcomes, however, this brings us into difficulties for the other outcome analyses where it is across participants - people not homes', 'achievements': [{'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'comment': 'completed follow-up data collection', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Intervention not implemented at their care home due to insufficient staff', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}], 'typeUnitsAnalyzed': 'care homes', 'recruitmentDetails': '2 did not meet eligibility criteria resulting in 47 participants enrolled across 10 care homes', 'preAssignmentDetails': 'did not meet age inclusion criterion'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group n = 47 Allocated', 'description': 'Digital music and movement resources.\n\ndanceSing Care: The programme was a digital movement and music programme with resources from danceSing Care (https://dancesingcare.uk/) and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'older adults living in residential care homes - Scotland'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-19', 'size': 770790, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-03T12:27', 'hasProtocol': True}, {'date': '2021-11-01', 'size': 175575, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-21T02:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2022-09-08', 'resultsFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2022-09-24', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-15', 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Participants' Programme Adherence as % Sessions Attended Out of the Possible Maximum Number of Sessions Delivered Per Care Home Aggregated as % Across All Care Homes.", 'timeFrame': 'Will be evaluated after completion of the 12-week intervention period', 'description': "The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators. Individual participants' adherence is calculated as the number of sessions they individually attended out of the possible number of sessions available to them in their care home. This is reported as the percentage of attended sessions per person per care home out of those delivered averaged per care home then aggregated across all care homes."}, {'measure': 'Number of Sessions Delivered, Assessed by Attendance Files', 'timeFrame': 'Will be evaluated after completion after the completion of the 12-week intervention period', 'description': "The activity coordinators will fill in participants' adherence after each session. The completed files will be sent through to the investigators."}, {'measure': 'Acceptability of the Intervention Assessed by Focus Groups - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc.', 'timeFrame': '1 month after completion after the completion of the 12-week intervention period', 'description': 'Investigators will conduct focus groups with the activity coordinators to assess acceptability of the intervention. Guide questions included:\n\nDid you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff?'}, {'measure': 'Acceptability of the Intervention Assessed by Interviews - Semi-structured Questions Covering Subjective Views on Enjoyment, Motivation, Duration, Content Etc.', 'timeFrame': '1 month after completion after the completion of the 12-week intervention period', 'description': 'Investigators will conduct focus groups/interviews with residents to assess acceptability of the intervention. Guide questions included:\n\nDid you enjoy using the danceSing Care online activities? Did you manage to take part in the 3+1 sessions a week? If not, why? Would you say duration of sessions was appropriate? Did you complete most of sessions or have to stop at any point? What did you like about the DSC activities? Was there anything you did not like? If you could change something about this programme to make it work effectively here, what would you change and why? Why did you take part? What made you continue to take part? What do you consider the outcomes of this program to have been for you? Would you like to carry on engaging in the DSC activities? Why/why not? Do you feel part of the DSC family/champions? Has engaging in the DSC activities brought you closer to other residents and staff?'}], 'secondaryOutcomes': [{'measure': 'Change in Fear of Falling Between Baseline and Within One Month of Completing the Intervention Using the Falls Efficacy Scale - International (Short Form)(FES-I)', 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).'}, {'measure': "Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of the Completion of the Intervention Using The Dartmouth COOP Charts", 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'Change in participant\'s Activities of daily living and health-related quality of life from baseline to within one month of the completion of the intervention using The Dartmouth COOP which has 5-point Likert-type scaling, with descriptors and cartoon illustrations of levels 1 through 5. Rating of "1" = no impairment, "5" = most impaired.'}, {'measure': "Change in Participant's Activities of Daily Living and Health-related Quality of Life From Baseline to Within One Month of Completing the Intervention Using EQ-5D-3L", 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': "The EQ-5D-3L descriptive system comprises the following five questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has a 3-point scale for rating it: no problems, some problems, and extreme problems (1-3). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are then combined to describe the patient's health state, with a higher TOTAL score describing a worse outcome. The range for total score is 5-15."}, {'measure': "Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Hospital Anxiety and Depression Scale (HADS)", 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \\>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. No total score is reported. Anxiety and Depression sub-scale totals are calculated separately by summing responses to the applicable 7 items each. The range for each sub-scale is 0-21. A higher score indicates a worse outcome.'}, {'measure': "Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Perceived Stress Scale (PSS)", 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.'}, {'measure': "Change in Participant's Psychosocial Wellbeing From Baseline to Within One Month of Completing the Intervention Using the Brief UCLA Loneliness Scale (ULS-6)", 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'Using a 4-point rating scale (1= never; 4 = always), participants answer 6 questions, such as "How often do you feel left out?" and "How often do you feel part of a group of friends?". The Brief UCLA Loneliness scale is summed across items to give one total score. The range for total score is 6-24. A higher score indicates worse loneliness, i.e. a worse outcome.'}, {'measure': "Change in Participant's Sleep Satisfaction From Baseline to Within One Month of Completing the Intervention Using the National Sleep Foundation's Sleep Satisfaction Tool (SST)", 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': "9-item questionnaire (scoring 1 not satisfied to 4 very satisfied) to assesses the general population's sleep satisfaction. The SST scale is summed across items to give one total score. The range for total score is 9-36."}, {'measure': "Change in Participant's Appetite From Baseline to Within One Month of Completing the Intervention Using the Simplified Nutritional Appetite Questionnaire (SNAQ)", 'timeFrame': 'Baseline and within 1 month of completion of the 12-week intervention period', 'description': 'This is used for limited frailty testing, a self-assessment nutritional screening tool that predicts weight loss, scoring 1 (very poor) to 4 (very good) on appetite-related topics.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['feasibility study', 'realist evaluation', 'care homes', 'clinical trial', 'physical activity', 'digital intervention', 'music and movement intervention', 'dance intervention'], 'conditions': ['Aged', 'Older Adults', 'Healthy Aging', 'Aging']}, 'referencesModule': {'references': [{'pmid': '36879201', 'type': 'RESULT', 'citation': 'Ofosu EF, De Nys L, Connelly J, Ryde GC, Whittaker AC. A realist evaluation of the feasibility of a randomised controlled trial of a digital music and movement intervention for older people living in care homes. BMC Geriatr. 2023 Mar 6;23(1):125. doi: 10.1186/s12877-023-03794-5.'}]}, 'descriptionModule': {'briefSummary': '* The investigators wanted to find out if digital music and movement resources could be delivered in care homes. They rolled out a 12-week programme to 10 care homes and had 47 care home residents participate in the research.\n* The investigators also wanted to find out under what circumstances the digital music and movement resources would be most effective for the health and wellbeing of the care home residents.\n* A survey measuring the number of falls in the past three months, activities of daily living and health, psychosocial wellbeing (anxiety, depression, stress and loneliness), sleep satisfaction and frailty measures such as appetite and weight loss) was completed before and after the intervention. Also, interviews with residents and focus groups with staff were done after the intervention to find out how they felt about the programme.', 'detailedDescription': "The specific research objectives were to evaluate the following topics:\n\n1. Feasibility: was the activity implemented and/or delivered as planned? Were the resources suitable for this setting? Were adherence rates at an acceptable level?\n2. Context: what is the role of the care homes in providing resources to the Activity Coordinators (ACs)? In what circumstances would the programme have worked most efficiently? What were the potential barriers for care homes or ACs to provide these resources?\n3. Mechanism: what underlying mechanisms made the danceSing Care programme work (or not)? Was it the situational context or the programme context?\n4. Outcome: What were the results? Were the outcomes adequate and realistic for this programme?\n5. Moderators: were moderating factors responsible? By moderating factors, we are referring to contextual factors that are out of the program's control but may help or hinder the achievement of the outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents in care homes ≥ 65 years,\n* able to complete 12 weeks of a movement and music program,\n* having the capacity to give informed consent.\n\nExclusion Criteria:\n\n* currently taking part in any other clinical trial which could potentially have an impact upon or influence the findings of the current study,\n* pre-existing conditions or concurrent diagnoses which would profoundly impact their capacity to undergo the intervention, even once adaptations have been made,\n* inability to understand written/spoken English adequately to participate in the measures and intervention (e.g., due to cognitive or sensory impairment).'}, 'identificationModule': {'nctId': 'NCT05559203', 'briefTitle': 'danceSing Care Evaluation: Testing the Feasibility', 'organization': {'class': 'OTHER', 'fullName': 'University of Stirling'}, 'officialTitle': 'A Realist Evaluation of the Feasibility of a Digital Music and Movement Intervention for Older People Living in Care Homes', 'orgStudyIdInfo': {'id': 'NICR 3735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Digital music and movement resources.', 'interventionNames': ['Behavioral: danceSing Care']}], 'interventions': [{'name': 'danceSing Care', 'type': 'BEHAVIORAL', 'description': 'The programme was a digital movement and music programme with resources from danceSing Care and consisted of three movement sessions and one music session each week, the recommended dose agreed between danceSing Care and the Advisory group, each lasting about 20 minutes. Also, the danceSing care resources were designed to suit older adults with physical and cognitive impairments (residents with mobility aids and/or dementia). Movement sessions included chair and standing fitness, which started with a warm-up and finished with stretching exercises. Sessions were managed and supervised by care home activity coordinators.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PH1 1RA', 'city': 'Perth', 'country': 'United Kingdom', 'facility': 'Balhousie Care Group', 'geoPoint': {'lat': 56.39522, 'lon': -3.43139}}], 'overallOfficials': [{'name': 'Anna Whittaker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Stirling'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Stirling', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Whittaker', 'investigatorAffiliation': 'University of Stirling'}}}}