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Caregiver StressNCT05497817

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

A study testing Algorithm and Random Match in people with Caregiver Stress and Dementia, run by Mayo Clinic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregiver Stress, Dementia, Alzheimer Dementia
What is being tested?
Algorithm and Random Match
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2022to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Fostering Caregiver Connections Via Intentional Technology Pairing for Caregivers of Patients With Alzheimer's Disease and Other Types of Dementia-Phase 2

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.

Being tested
Algorithm, Random Match
Medical subject headings
Caregiver Burden, Dementia, Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlgorithmBehavioural

    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.

  • Random MatchBehavioural

    Current and/or former Care Partners of persons with dementia will be randomly matched to other Care Partners who might provide emotional support.

Study groups in NCT05497817
Study groupRoleWhat they receive
Algorithmically MatchedExperimentalIndividuals 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.
Receives: Behavioral: Algorithm
Randomly MatchedActive comparatorIndividuals that identify as a current and/or former Care Partner for a person with dementia will be randomly matched to other care partners.
Receives: Behavioral: Random Match

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: Baseline,12 months

  3. 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.

    Measured: Baseline, 12 months

  4. Scale of Perceived Social Support

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

    Measured: 12 months

Secondary outcomes (1)

  1. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: Study withdrawn and being modified under another protocol

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497817
Sponsor's protocol ID
20-013202
Other IDs
R44AG065088
Status last verified
Nov 2022
First submitted
8 Aug 2022
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Algorithm and Random Match in people with Caregiver Stress and Dementia, run by Mayo Clinic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Match Satisfaction Questionnaire (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05497817.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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