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A Study to Evaluate Caregiver Connections Via Technology for Patients With Alzheimer's and Other Types of Dementia

Primary Purpose

Caregiver Stress, Dementia, Alzheimer Dementia

Status
Withdrawn
Phase
Not Applicable
Locations
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

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.

Sites / Locations

    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 Care Partner for a person with dementia will be matched to other care partners using an algorithm based on personal preferences.

    Individuals that identify as a current and/or former Care Partner for a person with dementia will be randomly matched to other care partners.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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 Care Partner match.

    Full Information

    First Posted
    August 8, 2022
    Last Updated
    November 14, 2022
    Sponsor
    Mayo Clinic
    Collaborators
    National Institute on Aging (NIA), Minnesota HealthSolutions
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05497817
    Brief Title
    A Study to Evaluate Caregiver Connections Via Technology for Patients With Alzheimer's and Other Types of 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
    November 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study withdrawn and being modified under another protocol
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    September 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, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caregiver Stress, Dementia, Alzheimer Dementia, 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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Algorithmically Matched
    Arm Type
    Experimental
    Arm Description
    Individuals that identify as a current and/or former Care Partner for a person with dementia will be matched to other care partners using an algorithm based on personal preferences.
    Arm Title
    Randomly Matched
    Arm Type
    Active Comparator
    Arm Description
    Individuals that identify as a current and/or former Care Partner for a person with dementia will be randomly matched to other care partners.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Algorithm
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Random Match
    Intervention Description
    Current and/or former Care Partners of persons with dementia will be randomly matched to other Care Partners who might provide emotional support.
    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 Care Partner via an algorithm based on personal preferences results in greater match satisfaction than being matched at random.
    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 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.
    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 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.
    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 Care Partner match.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julie Fields, PhD, LP
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kevin Kramer, PhD
    Organizational Affiliation
    Minnesota HealthSolutions, Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    A Study to Evaluate Caregiver Connections Via Technology for Patients With Alzheimer's and Other Types of Dementia

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