Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05885620
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2023-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D000093902', 'term': 'Mixed Dementias'}, {'id': 'D020774', 'term': 'Pick Disease of the Brain'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'User Experience', 'timeFrame': 'directly after intervention', 'description': 'Assessment of overall user experience with questionnaire. Qualitative Data.'}], 'primaryOutcomes': [{'measure': 'Success', 'timeFrame': 'during procedure', 'description': "Observation of success regarding to researchers' success protocol.\n\nMeasurement is performed in the following:\n\n1\\) Live observation during procedure rated with 0, 0.5 or 1 point: 0 points: Participant shows no activity that could potentially lead to task fulfillment.\n\n0.5 points: Participant intiated actions that result in incomplete task fulfillment.\n\n1 point: Participant completely fullfilled the task (task A: drunk some water tasb B: circled something on the worksheet with the pencil).\n\nOnly the best performance for each task was rated. Repetitions were not scored. The scores of both tasks were summarized, resulting in success values from 0 to 2 points."}], 'secondaryOutcomes': [{'measure': 'Usability', 'timeFrame': 'directly after intervention', 'description': 'Measurement of perceived usability according to score calculated from 10 items of post-intervention questionnaire.\n\nItems were answered on a 5-step Likert scale. Negatively worded items were converted.\n\nEach item was rated with 0,1,2,3 or 4 corresponding to the answer on the Likert scale with the following direction: 0 is used for the strongest disagreement, 4 for strongest agreement. Then the sum of all scores is multiplied with 2.5, leading to possible usability scores from 0 to 100. Higher scores present better usability.'}, {'measure': 'Design', 'timeFrame': 'directly after intervention', 'description': 'Measurement of satisfaction with design assessed with 6 items of post-intervention questionnaire.\n\nItems were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement.\n\nLower scores present higher satisfaction with design.'}, {'measure': 'Usefulness', 'timeFrame': 'directly after intervention', 'description': 'Assessment of perceived usefulness captured with 3 items of post-intervention questionnaire.\n\nItems were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement.\n\nLower scores present higher perceived usefulness.'}, {'measure': 'Concerns', 'timeFrame': 'directly after intervention', 'description': 'Assessment of concerns and barriers captured with 7 items of post-intervention questionnaire.\n\nItems were answered on a 5-step Likert scale. Each item was rated with 1,2,3, 4 or 5 corresponding to the answer on the Likert scale with the following direction: 1 is used for the strongest agreement, 5 for the strongest disagreement. Negatively worded items (5 items) were converted.\n\nLower scores represent less concerns.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Assistive technology', 'User-centered design', 'Usability', 'Smartwatch', 'Dementia'], 'conditions': ['Dementia', 'Mild Cognitive Impairment', 'Alzheimer Disease', 'Dementia With Lewy Bodies', 'Dementia, Vascular', 'Dementia, Mixed', 'Dementia Frontotemporal']}, 'referencesModule': {'references': [{'pmid': '38848116', 'type': 'DERIVED', 'citation': 'Goerss D, Kohler S, Rong E, Temp AG, Kilimann I, Bieber G, Teipel S. Smartwatch-Based Interventions for People With Dementia: User-Centered Design Approach. JMIR Aging. 2024 Jun 7;7:e50107. doi: 10.2196/50107.'}]}, 'descriptionModule': {'briefSummary': 'Assistive Technologies (ATs) can help people living with dementia (PwD) maintain their everyday activity. Still, there is a gap between potential and supply. Involving future users can close the gap. But the value of participation from PwD is unclear.\n\nThe study examined smartwatch interactions from people with dementia or with mild cognitive impairment. Participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. Participants\' reactions were observed via cameras. Users\' feedback was captured with questionnaires.', 'detailedDescription': 'This was a mixed methods study involving different stakeholder groups in a stepwise approach towards the user-centered evaluation of a smartwatch-based application for PwD. A preparatory qualitative study focused on identifying needs and requirements for mobile assistive devices. An observatory field study revealed potential use cases for smartwatches for persons with dementia. The subsequent intervention study examined smartwatch interactions and gathered users\' feedback concerning usability, design, usefulness and concerns. Participants with mild cognitive impairment or dementia received either "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts to perform everyday tasks. All participants were prompted to complete two tasks, prompts were repeated up to three times if they failed to completely solve a task. Prompts were triggered using a smartphone as remote control. Patient reactions were observed via video cameras. Each task was rated with 1 point for success, 0.5 for incomplete task fulfillment or 0 for failure. Both tasks were summarized, resulting in success values from 0 to 2 points.\n\nAbbreviations:\n\nPwD: people with dementia MCI: mild cognitive impairment AT: assistive technology'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of mild cognitive impairment or dementia\n* Mini Mental Status Examination (MMSE) ≥ 9 and ≤ 28 points\n\nExclusion Criteria:\n\n* clinically relevant impairment of visual acuity and/or hearing\n* relevant speech/language impairment'}, 'identificationModule': {'nctId': 'NCT05885620', 'acronym': 'SAIN_UMR', 'briefTitle': 'SAMi Intervention Study to Evaluate Smartwatch Interventions in Persons With MCI and Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Rostock'}, 'officialTitle': 'Sensor-based Individualized Activity Management System for People With Dementia: Intervention Study', 'orgStudyIdInfo': {'id': 'A 2020-0071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'regular', 'description': 'components of interventions:\n\n1. short vibration and short audio signal,\n2. textual greeting,\n3. textual prompt,\n4. picture\n5. short vibration', 'interventionNames': ['Device: drinking reminder and cognitive task (smartwatch-based application)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intense', 'description': 'components of interventions:\n\n1. long vibration and long audio signal,\n2. textual greeting,\n3. textual prompt and speech output,\n4. animation\n5. long vibration', 'interventionNames': ['Device: drinking reminder and cognitive task (smartwatch-based application)']}], 'interventions': [{'name': 'drinking reminder and cognitive task (smartwatch-based application)', 'type': 'DEVICE', 'description': 'task A: prompt to drink some water task B: prompt to circle bells on a sheet', 'armGroupLabels': ['intense', 'regular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Rostock University Medical Center', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Doreen Görß, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rostock University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rostock', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Center for Neurodegenerative Diseases (DZNE)', 'class': 'OTHER'}, {'name': 'Fraunhofer Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Doreen Goerss', 'investigatorAffiliation': 'University of Rostock'}}}}