Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-01-01 @ 7:41 PM
Study NCT ID:
NCT05255068
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OPTIMAL in NH Residents With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C105911', 'term': 'Optimal Pressed Ceramic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wen-liu-1@uiowa.edu', 'phone': '3193557104', 'title': 'Wen Liu', 'organization': 'The University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event were collected at 3 time points: baseline (T1), immediately post intervention (6 weeks post baseline, T2), and 6-week post intervention (12 weeks post baseline, T3).', 'description': 'The definition of adverse event and/or serious adverse event, used to collect adverse event information, is not different from the clinicaltrials.gov Definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Residents', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Families', 'description': 'In this study, we were initially planning to recruit families for our Aim 1 to collect feedback on the OPTIMAL intervention. The fact that we recruited 94 staff (initially planned for 20 staff recruitment), which is much more than we planned, and we were able to collect feedback from these staff on the OPTIMAL intervention which helped refinement of the intervention. Our team agreed that we received adequate feedback to move to Aim 2 and 3 (testing the OPTIMAL intervention in NH staff and residents, where families were not included in the proposed study). Therefore, we did not enroll families as participants, but communicated with them regarding the refined OPTIMAL and engaged N=5 family members in this effort where they served as community stakeholders and no individual characteristics were needed to be collected (rather than study participants/subjects who need to consent to be enrolled and followed up over time).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After recruitment of staff participants and before T1 (baseline)', 'description': 'All staff participants were interviewed on whether the intervention protocol and training materials were acceptable and appropriate for nursing home mealtime care practice before pilot testing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only the staff arm/group was assessed for this outcome measure, because only staff participants received training materials and training sessions directly from research team. In addition, the "residents" arm/group consisted of people living with moderate-to-severe dementia and were not able to provide accurate and valid information regarding whether the intervention protocol and training materials were acceptable and appropriate for nursing home mealtime care practice.'}, {'type': 'PRIMARY', 'title': 'Number of Staff and Resident Participants Recruited and Retained for the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.'}, {'id': 'OG001', 'title': 'Residents', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From recruitment/consent throughout the study completion, up to 12-weeks post baseline', 'description': 'The number of staff and resident participants that were recruited at baseline and retained over the study period were collected to indicate the feasibility of the study on participant recruitment, consent and retention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These are the number of staff and resident participants that were recruited at baseline'}, {'type': 'PRIMARY', 'title': 'The Number of Staff Participants Who Attended All Training Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During each OPTIMAL training session (within 2 weeks post baseline)', 'description': 'A checklist was used to track the number of staff participants who attended all the group and/or individual training sessions that were provided in the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 94 staff participants attended all the training sessions provided during the study'}, {'type': 'PRIMARY', 'title': 'Staff Person-centered Care Knowledge and Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Right before and after OPTIMAL training session (within 2 weeks post baseline)', 'description': 'Training receipt, indicated by a total score of ≥ 75% on the staff PCMC-related knowledge \\& self-efficacy test post-training with or without booster sessions. The total score of the scale ranges from 0 - 20, and higher scores are better. we recorded the number of staff who reached this cutoff score post training.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Staff Participants Who Viewed the Intervention Was Useful', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After T3 data collection time point (12-weeks post baseline)', 'description': 'All staff participants were interviewed on whether the intervention was useful post testing. The number of staff participants who viewed the intervention was useful was collected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 94 staff participants were interviewed on whether the intervention was useful post testing.'}, {'type': 'PRIMARY', 'title': 'The Number of Mealtime Difficulty Behaviors Observed in Residents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Residents', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.5', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Videos will be coded using the Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme that have codes for resident mealtime difficulties including 1) resistive behaviors and 2) functional impairments. we recorded the number of behaviors representing mealtime difficulties presented by residents, the higher the number, the worse the outcome.', 'unitOfMeasure': 'number of mealtime difficulty behaviors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Resident Level of Eating Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Residents', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '31', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '28.4', 'spread': '8.4', 'groupId': 'OG000'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '27.4', 'spread': '8.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Level of Eating Independence Scale, a 9-item scale assessing the ability of independence with eating and drinking activities during cycles of verbal prompts, will be used to measure. Each item is scored from 1 (total dependence) to 4 (total independence), with total score ranging from 9 to 36 (higher score = more independence).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Resident Intake Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Residents', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '94.3', 'spread': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '92.2', 'spread': '7.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '91.1', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Videos will be coded using CUED to track whether the resident or staff initiates/completes each intake attempt and whether there is a subsequent intake after each attempt. Resident intake success rate will be calculated by dividing the number of intake attempts initiated/completed by the resident with subsequent intake by the total number of intake attempts coded during one meal. the percent can range from 0 - 100%, the higher the number, the more independent the resident.', 'unitOfMeasure': 'percentage of resident successful intake', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Staff Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.2', 'spread': '14.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '13.9', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '16.3', 'spread': '5.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Quality of staff engagement will be assessed by Mealtime Engagement Scale developed by the PI with evidence of reliability and validity (each item is scored on 0-3, total score range: 0-57, higher score = higher quality of engagement).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resident Body Mass Index (BMI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Residents', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '30.9', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '30.1', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '30.1', 'spread': '5.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Resident Body Mass Index (BMI, unit is kg/m2). We will assess body weight in the early morning before breakfast with each individual resident dressing casual indoor clothes without shoes using the same digital body scale throughout the study. We will assess body weight twice in one early morning of each time point and calculate the average of the two assessments for BMI.', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.'}, {'id': 'FG001', 'title': 'Residents', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Families were to be recruited for Aim 1 only to collect feedback on OPTIMAL. We recruited 94 staff, much more than we planned (20 staff) and were able to collect adequate feedback from 94 staff on OPTIMAL for refinement. Our team agreed to move to Aim 2 and 3 (testing OPTIMAL in NH staff and residents) and we did not enroll families as participants but engaged some families of resident participants as community stakeholders (vs. participants/subjects) in refining OPTIMAL.', 'preAssignmentDetails': 'A total of 111 participants (94 staff, 17 residents) were enrolled at baseline, 1 resident lost to follow up at data collection time point 2, resulting in a total of 110 participants who retained in follow up data collections.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm1', 'description': 'OPTIMAL\n\nOPTIMAL: A person-centered mealtime care intervention.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Resident participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '7.9', 'groupId': 'BG000'}]}]}, {'title': 'Staff Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44.8', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '111 participants (overall number) = 17 resident participants + 94 staff participants'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Resident participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Staff participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '111 participants (overall number) = 17 resident participants + 94 staff participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'resident participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'While', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Non white', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'staff participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'title': 'While', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Non white', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '111 participants (overall number) = 17 resident participants + 94 staff participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'title': 'Resident Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'up to high school', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'some college/college graduate/post-college', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': "don't know/refused", 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Staff Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'title': 'up to high school', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'some college/college graduate/post-college', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': "don't know/refused", 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '111 participants (overall number) = 17 resident participants + 94 staff participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-17', 'size': 226387, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-17T16:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Because this study is a single-group design, all participants were recruited from the nursing home site that was assigned as the intervention group. no one is blinded to the intervention assignment, but all participants and outcome assessors were blinded for the research questions/aims.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2022-01-17', 'resultsFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2022-02-15', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-13', 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Staff Participants Who Viewed the Intervention as Appropriate and Acceptable for Mealtime Care Practice', 'timeFrame': 'After recruitment of staff participants and before T1 (baseline)', 'description': 'All staff participants were interviewed on whether the intervention protocol and training materials were acceptable and appropriate for nursing home mealtime care practice before pilot testing.'}, {'measure': 'Number of Staff and Resident Participants Recruited and Retained for the Study', 'timeFrame': 'From recruitment/consent throughout the study completion, up to 12-weeks post baseline', 'description': 'The number of staff and resident participants that were recruited at baseline and retained over the study period were collected to indicate the feasibility of the study on participant recruitment, consent and retention.'}, {'measure': 'The Number of Staff Participants Who Attended All Training Sessions', 'timeFrame': 'During each OPTIMAL training session (within 2 weeks post baseline)', 'description': 'A checklist was used to track the number of staff participants who attended all the group and/or individual training sessions that were provided in the study.'}, {'measure': 'Staff Person-centered Care Knowledge and Self-efficacy', 'timeFrame': 'Right before and after OPTIMAL training session (within 2 weeks post baseline)', 'description': 'Training receipt, indicated by a total score of ≥ 75% on the staff PCMC-related knowledge \\& self-efficacy test post-training with or without booster sessions. The total score of the scale ranges from 0 - 20, and higher scores are better. we recorded the number of staff who reached this cutoff score post training.'}, {'measure': 'Number of Staff Participants Who Viewed the Intervention Was Useful', 'timeFrame': 'After T3 data collection time point (12-weeks post baseline)', 'description': 'All staff participants were interviewed on whether the intervention was useful post testing. The number of staff participants who viewed the intervention was useful was collected.'}, {'measure': 'The Number of Mealtime Difficulty Behaviors Observed in Residents', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Videos will be coded using the Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme that have codes for resident mealtime difficulties including 1) resistive behaviors and 2) functional impairments. we recorded the number of behaviors representing mealtime difficulties presented by residents, the higher the number, the worse the outcome.'}, {'measure': 'Resident Level of Eating Performance', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Level of Eating Independence Scale, a 9-item scale assessing the ability of independence with eating and drinking activities during cycles of verbal prompts, will be used to measure. Each item is scored from 1 (total dependence) to 4 (total independence), with total score ranging from 9 to 36 (higher score = more independence).'}, {'measure': 'Resident Intake Success Rate', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Videos will be coded using CUED to track whether the resident or staff initiates/completes each intake attempt and whether there is a subsequent intake after each attempt. Resident intake success rate will be calculated by dividing the number of intake attempts initiated/completed by the resident with subsequent intake by the total number of intake attempts coded during one meal. the percent can range from 0 - 100%, the higher the number, the more independent the resident.'}], 'secondaryOutcomes': [{'measure': 'Quality of Staff Engagement', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Quality of staff engagement will be assessed by Mealtime Engagement Scale developed by the PI with evidence of reliability and validity (each item is scored on 0-3, total score range: 0-57, higher score = higher quality of engagement).'}, {'measure': 'Resident Body Mass Index (BMI).', 'timeFrame': 'T1 (baseline), T2 (6-weeks post baseline), T3 (12-weeks post baseline)', 'description': 'Resident Body Mass Index (BMI, unit is kg/m2). We will assess body weight in the early morning before breakfast with each individual resident dressing casual indoor clothes without shoes using the same digital body scale throughout the study. We will assess body weight twice in one early morning of each time point and calculate the average of the two assessments for BMI.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease and Related Dementias", 'Mealtime', 'Eating', 'Behavioral Symptoms', 'Food Intake', 'Function', 'Nutrition', 'Nursing Homes'], 'conditions': ["Alzheimer's Disease and Related Dementias"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and refine OPTIMAL and evaluate its feasibility, fidelity, and usefulness. The OPTIMAL is designed to teach staff to effectively engage residents in eating using individualized, person-centered behavioral strategies.', 'detailedDescription': 'This study developed and refined OPTIMAL, and evaluated its feasibility, fidelity, and usefulness. We used mixed methods (i.e., focus groups, a pilot single-group repeated measures) to refine and test OPTIMAL. We collected repeated measures at 3 time points: baseline (T1), immediately post intervention (6 weeks post baseline, T2), and 6-week post intervention (12 weeks post baseline, T3). At each time point, we assessed quality of staff engagement and resident outcomes including eating performance and BMI through collection and coding of videotaped observations of dyadic mealtime interaction (videos; Aim 2\\&3) over 6 meals in 2 consecutive days (2 breakfasts, 2 lunches, 2 dinners) for each staff-resident dyad. We used Cue Utilization and Engagement in Dementia (CUED) mealtime video coding scheme, an innovative, feasible, and reliable tool that our team has developed and validated, and assessed resident mealtime challenging behaviors including resistive behaviors and functional impairments and intake success rate using videos collected in this study.11, 25\n\nThe specific aims are:\n\n1. Develop, evaluate, and refine OPTIMAL intervention protocol and training materials. We will integrate evidence from literature and our prior work to develop the intervention protocol and training materials, addressing resident mealtime difficulties, targeted PCMC strategies, and establishment of individualized PCMC plans. We will conduct separate focus group interviews of staff and family participants on the acceptability and appropriateness of the intervention protocol and training materials before pilot testing. Data obtained will be used to refine the intervention protocol and training materials before pilot testing.\n2. Determine feasibility, fidelity, and usefulness of OPTIMAL. Feasibility on participant identification, recruitment, consent, and retention will be evaluated descriptively. Fidelity will be assessed on a) delivery of treatment (staff attendance to training sessions), b) receipt of treatment (staff knowledge and self-efficacy pre- \\& post-training), and c) enactment of treatment skills (staff PCMC\\&TCMC behaviors, quality of staff engagement). We will conduct focus group interviews of staff to assess the usefulness of OPTIMAL after T3.\n3. Describe resident outcomes (Exploratory). We will measure and describe resident mealtime difficulties, eating performance, intake success rate, body weight, and body mass index using descriptive statistics over time for two treatment groups. Data obtained will inform estimates of effect sizes for a future larger-scale trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "The investigators will recruit direct care staff, families of residents, and residents with dementia from NH sites following the exclusion and inclusion criteria after attrition rates are considered.\n\nInclusion Criteria:\n\nResidents\n\n* ≥ 55 years\n* Diagnosed as having ADRD based on medical records\n* Identified by NH staff as requiring mealtime assistance\n* Having a legally authorized representative (LAR) providing informed written consent\n\nStaffs\n\n* ≥18 years\n* English speaking\n* A permanent facility employee\n* Provide direct mealtime care for a resident participant at least twice a week over the previous month\n\nFamilies\n\n* ≥18 years\n* English speaking\n* A family member of the resident who is living at the NH study site at the time of the study\n* Having experience of delivering mealtime care to their resident family members\n\nExclusion Criteria:\n\nResidents\n\n* Have a documented diagnosis of Parkinson's disease, traumatic brain injury, or swallowing disorder,\n* Do not eat orally (e.g., parenteral/IV feedings, feeding tubes)\n* Unable to hear or see staff even with glasses and/or hearing aids (e.g., uncorrected visual or hearing impairment)\n* Stay in the NH study site for less than 12 weeks at the time of recruitment/consent/assent (e.g., terminally ill receiving hospice services, and/or receiving post-hospital skilled rehabilitation) that may not allow enough time for obtaining consent/assent, and scheduling days for video recording sessions across three-time points (baseline, and 6- and 12- weeks post-baseline)"}, 'identificationModule': {'nctId': 'NCT05255068', 'briefTitle': 'OPTIMAL in NH Residents With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': "Optimizing Mealtime Care (OPTIMAL): Development and Pilot Testing of a Person-Centered Mealtime Care Intervention for Nursing Home Residents With Alzheimer's Disease and Related Dementias (ADRD)", 'orgStudyIdInfo': {'id': 'K23AG066856', 'link': 'https://reporter.nih.gov/quickSearch/K23AG066856', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23AG066856', 'link': 'https://reporter.nih.gov/quickSearch/K23AG066856', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Staff', 'description': 'Start participants who enrolled in the study, received the OPTIMAL intervention, and were observed during data collection.', 'interventionNames': ['Behavioral: OPTIMAL']}, {'type': 'EXPERIMENTAL', 'label': 'Resident', 'description': 'Resident participants who were cared in the study site, and received care from the staff participants before and after the OPTIMAL intervention was delivered to staff.', 'interventionNames': ['Behavioral: OPTIMAL']}], 'interventions': [{'name': 'OPTIMAL', 'type': 'BEHAVIORAL', 'description': 'A person-centered mealtime care intervention', 'armGroupLabels': ['Resident', 'Staff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50158', 'city': 'Marshalltown', 'state': 'Iowa', 'country': 'United States', 'facility': "Iowa Vateran's Home", 'geoPoint': {'lat': 42.04943, 'lon': -92.90798}}], 'overallOfficials': [{'name': 'Liu Wen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University Of Iowa College Of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wen Liu', 'investigatorAffiliation': 'University of Iowa'}}}}