Caregiver StressNCT05779839
A Study of Caregiver Connections Via Technology in Dementia
A study testing Algorithm and Random Match in people with Caregiver Stress and Dementia, run by Mayo Clinic at 1 site in United States.
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 Disease
- What is being tested?
- Algorithm and Random Match
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 22 Mar 2026
- Phase
- Interventional
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 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
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, 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.
- Conditions
- Caregiver Stress, Dementia, Alzheimer Disease, Lewy Body Dementia, Parkinson Disease Dementia, Frontotemporal Dementia
- 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
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.
Random MatchBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Algorithmically Matched | Experimental | 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. Receives: Behavioral: Algorithm |
| Randomly Matched | Active comparator | 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. Receives: Behavioral: Random Match |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
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.
Measured: Baseline, 12 months
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.
Measured: Baseline, 12 months
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)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start6 Feb 2023
- Primary completion22 Mar 2026
- Study completion22 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver StressStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Minnesota HealthSolutions
- Responsible party
- Principal investigator, Julie A. Fields, Ph.D., L.P., Mayo Clinic
- Investigators
- Julie Fields, PhD, LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779839
- Sponsor's protocol ID
- 22-008835
- Other IDs
- R44AG065088
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No