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

NCT05497817 | Withdrawn

• 2 other identifiers: 20-013202R44AG065088
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caregiver Stress; Dementia; Alzheimer Dementia; Lewy Body Dementia; Parkinson Disease Dementia; Frontotemporal Dementia

Outcome Measures

Primary Outcomes (4)

• 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.

  12 months

• 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.

  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 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.

  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.

  12 months

Secondary Outcomes (1)

• Survey of Executive Skills

  12 months

Study Arms (2)

Algorithmically Matched

EXPERIMENTAL

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.

Behavioral: Algorithm

Randomly Matched

ACTIVE COMPARATOR

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

Behavioral: Random Match

Interventions

Algorithm BEHAVIORAL

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.

Algorithmically Matched

Random Match BEHAVIORAL

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

Randomly Matched

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator
• Minnesota HealthSolutions: collaborator

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Caregiver Burden; Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia

Interventions

Algorithms

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Julie Fields, PhD, LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Kevin Kramer, PhD

  Minnesota HealthSolutions, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 17, 2022

Record last verified: 2022-11