Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-09 @ 2:35 AM
Study NCT ID:
NCT05527405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'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': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a randomized controlled clinical trial in which two conditions will be investigated: a control and an experimental condition.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in User Interaction and Engagement from baseline at 6 months', 'timeFrame': 'Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)', 'description': "18-item quality-of-life questionnaire (QoL-18) evaluates a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-10. A higher number indicates better outcome."}, {'measure': 'Change in Zarit Burden Assessment Caregiver Strain instrument from baseline at 6 months', 'timeFrame': 'Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)', 'description': '18-item questionnaire assessing the various stresses caregivers experienced relating to caring for an individual with cognitive impairment. The total score ranges from 0-72, with a higher score reflecting higher stress and burden on the caregiver.'}, {'measure': "Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months", 'timeFrame': 'Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)', 'description': "Assesses an individual with dementia's ability to carry out activities of daily living. The total score ranges from 0-53, with a higher score representing better performance in completing activities of daily living by the individual with dementia."}, {'measure': 'Change in Quality of Life - 18 (QoL-18) from baseline at 6 months', 'timeFrame': 'Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)', 'description': "18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the middle and end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-10. A higher number indicates better outcome."}, {'measure': 'Change in Brief Quality of Life - 8 (QoL-8) from baseline at 6 months', 'timeFrame': 'Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)', 'description': "8-items selected from the Wisconsin Quality of Life Caregiver Questionnaire evaluated a range of participants' behaviors, including mood, engagement, and memory at the middle and end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-10. A higher number indicates better outcome."}, {'measure': 'Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months', 'timeFrame': 'Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)', 'description': '12-item, caregiver self-report measure of stress levels'}], 'secondaryOutcomes': [{'measure': '2-item Satisfaction Scale (SS-2)', 'timeFrame': 'The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)', 'description': "Quantifies caregivers' endorsements to two survey questions: How satisfied were they with the MHS? Would they recommend MHS to others? Both questions are scored on a 10-point scale, with a higher value reflecting a better outcome/experience."}, {'measure': 'Pain and Sleep Questionnaire', 'timeFrame': 'Pre-Post: The assessment will be administered at baseline, post-intervention (6 months)', 'description': '5-item questionnaire developed to assess the impact of pain on quality of sleep'}, {'measure': 'Generalized Anxiety Disorder (GAD7) Scale', 'timeFrame': 'Pre-Post: The assessment will be administered at baseline, post-intervention (6 months)', 'description': '7-item questionnaire used as an initial screening tool for generalized anxiety disorder'}, {'measure': 'Anger Management Scale', 'timeFrame': 'Pre-Post: The assessment will be administered at baseline, post-intervention (6 months)', 'description': '12-item questionnaire designed to monitor and evaluate progress in controlling and managing anger'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer Disease', 'Dementia', 'Caregiver Burden', 'Activities of Daily Living', 'Assistive Technology'], 'conditions': ['Alzheimer Disease', 'Dementia', 'Caregiver Burden', 'Assistive Technology']}, 'referencesModule': {'references': [{'pmid': '31796718', 'type': 'BACKGROUND', 'citation': 'Boatman F, Golden M, Jin J, Kim Y, Law S, Lu A, Merriam N, Zola S. Assistive technology: Visual mapping combined with mobile software can enhance quality of life and ability to carry out activities of daily living in individuals with impaired memory. Technol Health Care. 2020;28(2):121-128. doi: 10.3233/THC-191980.'}, {'pmid': '34269690', 'type': 'BACKGROUND', 'citation': 'Kelleher J, Zola S, Cui X, Chen S, Gerber C, Parker MW, Davis C, Law S, Golden M, Vaughan CP. Personalized Visual Mapping Assistive Technology to Improve Functional Ability in Persons With Dementia: Feasibility Cohort Study. JMIR Aging. 2021 Oct 19;4(4):e28165. doi: 10.2196/28165.'}, {'pmid': '34334439', 'type': 'BACKGROUND', 'citation': 'Parker MW, Davis C, White K, Johnson D, Golden M, Zola S. Reduced care burden and improved quality of life in African American family caregivers: Positive impact of personalized assistive technology. Technol Health Care. 2022;30(2):379-387. doi: 10.3233/THC-213049.'}]}, 'descriptionModule': {'briefSummary': "As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system (MHS) will offer a caregiver training product that is linked to MHS, an Alzheimer's disease or related dementias (AD/ADRD) assistive technology product that uses visual maps to improve a patient's behavior and sense of autonomy. MapHabit's combined areas of focus, i.e., offer a single integrated product to address the caregiver and the person under this caregiver's care, are unique and will create a new standard in the field to reduce caregiver burden in the setting of caring for individuals with AD/ADRD. Additionally, the study will integrate enhanced user support modules, i.e., gamifying, dashboarding, and social networking, to improve the Caregiver Training Program (CTP) experience.The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) control condition in which the MHS alone is incorporated in the participant's daily care and 2) experimental condition in which the MHS+CTP is implemented into the daily care received by participants. The sample size will be a total of 50 patient-caregiver dyads, 25 in each condition. The study duration will be a 6-month intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment\n* Participating caregiver of individual with dementia must be the primary caregiver\n* Proficient in English\n\nExclusion Criteria:\n\n* Individual not diagnosed with ADRD\n* Participating caregiver of individual with dementia is NOT the primary caregiver\n* Not proficient in English"}, 'identificationModule': {'nctId': 'NCT05527405', 'briefTitle': 'Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'MapHabit, Inc.'}, 'officialTitle': 'Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes in Visual Mapping Assistive Technology', 'orgStudyIdInfo': {'id': 'Fast Track - CTP (NIH-SBIR)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caregiver Training Program', 'description': "This condition will involve the implementation of an assistive technology software (named the MapHabit System) with an added Caregiver Training Program into the daily care of individuals with mild to moderate stages of Alzheimer's disease and related dementias. The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). The application will be made available to families through compatible tablets.", 'interventionNames': ['Device: The MapHabit System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'The MapHabit System', 'description': 'This control condition will act as the active comparator to the experimental condition. The same assistive technology, the MapHabit System, will be given to a separate group of participants. The difference here will be that the software will be a version that does not include the caregiver training program.', 'interventionNames': ['Device: The MapHabit System']}], 'interventions': [{'name': 'The MapHabit System', 'type': 'DEVICE', 'description': 'The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). The goal of the application is to develop and facilitate habits and routines using structured visual and auditory stimuli that can be customized by the user and can include educational and lesson-based material in addition to ADLs. The application will be made available through tablets. Depending on the condition, participants will receive a specific version of the application. The experimental condition will receive the version that incorporates gamified structure and the Caregiver Training Program.\n\nThe MHS is a general wellness product. This functionality is not a regulated medical device.', 'armGroupLabels': ['Caregiver Training Program', 'The MapHabit System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MapHabit, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Stuart Zola', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MapHabit, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal. Proposals should be directed to szola@maphabit.com. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MapHabit, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Scientific Officer', 'investigatorFullName': 'Stuart Zola', 'investigatorAffiliation': 'MapHabit, Inc.'}}}}