search
Back to results

A Study of Caregiver Connections Via Technology in Dementia

Primary Purpose

Caregiver Stress, Dementia, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Algorithm
Random Match
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Algorithmically Matched

Randomly Matched

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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.
Scale of Perceived Social Support
All participants will complete survey questions regarding perceived level of social support to assess impact on match satisfaction.

Secondary Outcome Measures

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.

Full Information

First Posted
February 21, 2023
Last Updated
March 23, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA), Minnesota HealthSolutions
search

1. Study Identification

Unique Protocol Identification Number
NCT05779839
Brief Title
A Study of Caregiver Connections Via Technology in Dementia
Official Title
Fostering Caregiver Connections Via Intentional Technology Pairing for Caregivers of Patients With Alzheimer's Disease and Other Types of Dementia-Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA), Minnesota HealthSolutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Stress, Dementia, Alzheimer Disease, Lewy Body Dementia, Parkinson Disease Dementia, Frontotemporal Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
355 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Algorithmically Matched
Arm Type
Experimental
Arm Description
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.
Arm Title
Randomly Matched
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Algorithm
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Random Match
Intervention Description
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.
Primary Outcome Measure Information:
Title
Match Satisfaction Questionnaire
Description
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
Time Frame
12 months
Title
Change over time from Baseline Resilience to 12 months
Description
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.
Time Frame
Baseline, 12 months
Title
Change over time from Baseline Quality of Life to 12 months
Description
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.
Time Frame
Baseline, 12 months
Title
Scale of Perceived Social Support
Description
All participants will complete survey questions regarding perceived level of social support to assess impact on match satisfaction.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Survey of Executive Skills
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shayna Amos
Phone
507-284-1324
Email
connect2caregivers@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Fields, PhD, LP
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

A Study of Caregiver Connections Via Technology in Dementia

We'll reach out to this number within 24 hrs