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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dementia; Frontotemporal Dementia; Alzheimer Dementia; Lewy Body Dementia; Parkinson Disease Dementia; Caregiver Stress
• Intervention / Treatment: Behavioral: Algorithm; Behavioral: Random Match

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Algorithmically Matched; 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; 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.
Active Comparator: Randomly Matched; 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; Current and/or former Care Partners of persons with dementia will be randomly matched to other Care Partners who might provide emotional support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA); Minnesota HealthSolutions
• Investigators: Principal Investigator: Julie Fields, PhD, LP, Mayo Clinic; Principal Investigator: Kevin Kramer, PhD, Minnesota HealthSolutions, Inc.

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
• Other Study ID Numbers: 20-013202; R44AG065088 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No