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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05497817
Other study ID # 20-013202
Secondary ID R44AG065088
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date December 2024

Study information

Verified date November 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is being done to develop a unique matching process for caregivers of persons living with dementia, such as Alzheimer's disease, Lewy body dementia, frontotemporal degeneration, or other dementia syndromes. Dementia caregivers often assume greater caregiving burden than do non-dementia caregivers, and the caregiving duration tends to be longer. Many caregivers do not have the adequate support they need. Peer-to-peer support has been shown to improve quality of life, increase use of services, improve caregiver health, and reduce hospitalizations in the person they are caring for. This study will assess a technology platform and matching process for the purpose of peer-to-peer emotional support aimed at improving overall wellbeing in dementia care partners/caregivers.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Individuals in a current or former caregiving role for a family member living with dementia will be recruited for this study. There will be no sex or gender restrictions, or exclusion based on race or ethnicity. Participants must be at least 18 years of age. Inclusion Criteria: - The participant must have a family member that has been diagnosed with 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 who 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. Exclusion Criteria: - Care Partner's loved one does not have a confirmed diagnosis of dementia. - Care Partner is unable to provide consent. - Care Partner was or has been in that role for less than 3 months.

Study Design


Intervention

Behavioral:
Algorithm
Current and/or former Care Partners of persons with dementia will be matched using an algorithm to other Care Partners who might provide emotional support.
Random Match
Current and/or former Care Partners of persons with dementia will be randomly matched to other Care Partners who might provide emotional support.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic Minnesota HealthSolutions, National Institute on Aging (NIA)

Outcome

Type Measure Description Time frame Safety issue
Primary Match Satisfaction Questionnaire All participants will complete a match satisfaction questionnaire to assess whether being matched to a supportive Care Partner via an algorithm based on personal preferences results in greater match satisfaction than being matched at random. 12 months
Primary Change over time from Baseline Resilience to 12 months All participants will complete questions surveying resilience to determine whether Care Partners randomized to algorithmic matching based on personal preferences will report a greater sense of resiliency after being matched than Care Partners who are randomly matched. Baseline,12 months
Primary Change over time from Baseline Quality of Life to 12 months All participants will complete questions surveying quality of life to determine whether Care Partners randomized to algorithmic matching based on personal preferences will report improved quality of life after being matched than Care Partners who are randomly matched. Baseline, 12 months
Primary Scale of Perceived Social Support All participants will complete survey questions regarding perceived level of social support to assess impact on match satisfaction. 12 months
Secondary Survey of Executive Skills 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 Care Partner match. 12 months
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