A Study of Caregiver Connections Via Technology in Dementia
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|ClinicalTrials.gov Identifier: NCT05779839|
Recruitment Status : Recruiting
First Posted : March 22, 2023
Last Update Posted : March 27, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Caregiver Stress Dementia Alzheimer Disease Lewy Body Dementia Parkinson Disease Dementia Frontotemporal Dementia||Behavioral: Algorithm Behavioral: Random Match||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||355 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly assigned to two different arms of the study: one where the algorithm matches individuals and one where matches are randomly assigned.|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Fostering Caregiver Connections Via Intentional Technology Pairing for Caregivers of Patients With Alzheimer's Disease and Other Types of Dementia-Phase 2|
|Actual Study Start Date :||February 22, 2023|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Experimental: Algorithmically Matched
Individuals that identify as a current and/or former caregiver for a person with dementia will be matched to other caregivers using an algorithm that matches a caregiver to another caregiver based on specific preferences each caregiver identifies in a questionnaire.
For purpose of finding peer-to-peer support, current and/or former caregivers of persons with dementia will be matched using an algorithm. They can then choose make a connection and maintain a connection for the duration of the study.
Active Comparator: Randomly Matched
Individuals that identify as a current and/or former caregiver for a person with dementia will be randomly matched to other caregivers not based on the preferences they identified in a questionnaire.
Behavioral: Random Match
For purpose of finding peer-to-peer support, current and/or former caregivers of persons with dementia will be randomly matched. They can then choose make a connection and maintain a connection for the duration of the study.
- Match Satisfaction Questionnaire [ Time Frame: 12 months ]
All participants will complete a match satisfaction questionnaire to assess whether being matched to a supportive caregiver via an algorithm based on personal preferences results in greater match satisfaction than being matched at random. Questions are scored from 0 to 4 with a possible total of 28.
Scores are interpreted such that an overall total of: 0 - 7 = low satisfaction; 8-14 = medium/average satisfaction; 15-28 = high satisfaction
- Change over time from Baseline Resilience to 12 months [ Time Frame: Baseline, 12 months ]All participants will complete questions surveying resilience to determine whether caregivers randomized to algorithmic matching based on personal preferences will report a greater sense of resiliency after being matched than caregivers who are randomly matched.
- Change over time from Baseline Quality of Life to 12 months [ Time Frame: Baseline, 12 months ]All participants will complete questions surveying quality of life to determine whether caregivers randomized to algorithmic matching based on personal preferences will report improved quality of life after being matched than caregivers who are randomly matched.
- Scale of Perceived Social Support [ Time Frame: 12 months ]All participants will complete survey questions regarding perceived level of social support to assess impact on match satisfaction.
- Survey of Executive Skills [ Time Frame: 12 months ]All participants will complete questions regarding executive functioning (e.g., flexibility, problem-solving) to determine whether the level of these skills relates to ease or difficulty in finding a satisfactory supportive caregiver match.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- The participant must have a family member that has been diagnosed with one of the following forms of dementia: Parkinson's/Lewy body dementia, any frontotemporal lobar degeneration dementia, or Alzheimer's dementia.
- The participant must identify as a care partner or caregiver who has contact with their loved one with dementia, in person or by phone, and provides social/emotional support and full or partial assistance with daily activities at least 3 days per week.
- The participant must have been caring for their loved one with dementia for at least 3 months.
- All participants must have access to a computer and be able to use the internet.
- All participants must be English speaking.
- All participants must agree to participate in the 15-month study, which includes completing questionnaires, brief "virtual" interactions with the study coordinator quarterly, and actively interacting with the website and potential matches.
- All participants must agree to follow-up contact throughout the duration of the study, which is anticipated to last 3 years.
- Caregiver's loved one does not have a confirmed diagnosis of dementia.
- Caregiver is unable to provide consent.
- Caregiver was or has been in that role for less than 3 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05779839
|Contact: Shayna Amosfirstname.lastname@example.org|
|United States, Minnesota|
|Mayo Clinic Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Julie Fields, PhD, LP||Mayo Clinic|
|Responsible Party:||Julie A. Fields, Ph.D., L.P., Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
R44AG065088 ( U.S. NIH Grant/Contract )
|First Posted:||March 22, 2023 Key Record Dates|
|Last Update Posted:||March 27, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Aphasia, Primary Progressive
Pick Disease of the Brain
Lewy Body Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Frontotemporal Lobar Degeneration