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A Study of Caregiver Connections Via Technology in Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05779839
Recruitment Status : Recruiting
First Posted : March 22, 2023
Last Update Posted : March 27, 2023
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Minnesota HealthSolutions
Information provided by (Responsible Party):
Julie A. Fields, Ph.D., L.P., Mayo Clinic

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 355 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Shayna Amos 507-284-1324 connect2caregivers@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
Minnesota HealthSolutions
Investigators
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Principal Investigator: Julie Fields, PhD, LP Mayo Clinic
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Julie A. Fields, Ph.D., L.P., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05779839    
Other Study ID Numbers: 22-008835
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
 Neurodegenerative Diseases
Tauopathies
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations