NCT03665909

A Proactive Health Monitoring Intervention for Dementia Caregivers

Completed NA Last updated 5 October 2023

What this trial tests

NA trial testing Remote activity monitoring system in Dementia in 179 participants. Completed in 8 April 2020.

Timeline

1 April 2014

Primary endpoint
31 March 2020

8 April 2020

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	179
Start date	1 April 2014
Primary completion	31 March 2020
Estimated completion	8 April 2020

Drugs / interventions tested

• Remote activity monitoring system

Conditions studied

• Dementia — all drugs for Dementia →
• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

University of Minnesota

Who can join

21 and older, any sex, with Dementia or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this 5-year demonstration project is to build on the work of The Lutheran Home Association (TLHA) and conduct an embedded experimental mixed methods evaluation to determine the efficacy of the eNeighbor technology in improving outcomes among persons with Alzheimer's disease or related dementias (ADRD) living in the community and their family caregivers. The Specific Aims are as follows: 1) To compare 100 ADRD caregivers randomly assigned to an attention control with 100 ADRD caregivers who utilize eNeighbor over an 18-month period to determine if the use of the remote sensor technology results in a) significant (p \< .05) increases in caregiver self-efficacy and sense of competence, b) significant decreases in caregiver distress (subjective stress, depressive symptoms), c) significant delays of or reductions in negative health transitions (falls, wandering events) and service utilization (residential care placement, hospitalizations) for persons with ADRD; and d) greater cost-effectiveness; 2) To determine through "embedded" qualitative data collection components how eNeighbor is successfully utilized and why this health monitoring technology benefits persons with ADRD and their family caregivers; and 3) To engage stakeholders on a quarterly basis throughout this 5-year demonstration project in order to enhance the utility and stakeholder-relevance of health monitoring technology for families who care for persons with ADRD. The investigators anticipate that the successful completion of the project aims will position the eNeighbor as an innovative, stakeholder-centric service that offers robust support for family caregivers of persons with ADRD in the community.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Remote activity monitoring for family caregivers of persons living with dementia: a mixed methods, randomized controlled evaluation.
   Gaugler JE, Zmora R, Mitchell LL, Finlay J, et al · · 2021 · cited 16× · PMID 34922475 · DOI 10.1186/s12877-021-02634-8