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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05779839
Other study ID # 22-008835
Secondary ID R44AG065088
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2023
Est. completion date December 2024

Study information

Verified date April 2024
Source Mayo Clinic
Contact Shayna Amos
Phone 507-284-1324
Email connect2caregivers@mayo.edu
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, more engagement with services, improve caregiver health, and reduce hospitalizations in the person they are caring for. This study will help determine whether caregivers of persons with dementia would find a technology-based caregiver matching program valuable for the purpose of emotional support.


Recruitment information / eligibility

Status Recruiting
Enrollment 355
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Behavioral:
Algorithm
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.
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.

Locations

Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

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 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
12 months
Primary Change over time from Baseline Resilience to 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. 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 caregivers randomized to algorithmic matching based on personal preferences will report improved quality of life after being matched than caregivers 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 caregiver match. 12 months
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