A Study of Caregiver Connections Via Technology in Dementia

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Algorithm

Random Match

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

NCT ID

NCT05779839

First Posted

February 21, 2023

Last Updated

March 23, 2023

Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA), Minnesota HealthSolutions

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

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

Caregiver Stress, Dementia, Alzheimer Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial