A Proactive Health Monitoring Intervention for Dementia Caregivers

NCT03665909 | Completed

• 2 other identifiers: 1401547541R18HS022836
• Study Type: interventional
• Target: 179
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Nursing home utilization at 18 months for the person with ADRD

  Caregiver report of nursing home use at 18 months.

  18-months

Secondary Outcomes (7)

• Perceptions of change in caregiver self-efficacy

  Baseline, 6-months, 12-months, 18-months

• Perceptions of change in caregiver competence

  Baseline, 6-months, 12-months, 18-months

• Perceptions of change in caregiver burden

  Baseline, 6-months, 12-months, 18-months

• Perceptions of change in caregiver role captivity

  Baseline, 6-months, 12-months, 18-months

• Change in caregiver role overload

  Baseline, 6-months, 12-months, 18-months

Study Arms (2)

Remote activity monitoring

EXPERIMENTAL

Receive the remote activity monitoring system (i.e., "eNeighbor;" see intervention description) over an 18-month period.

Other: Remote activity monitoring system

Control

NO INTERVENTION

Control participants do not receive the remote activity monitoring intervention.

Interventions

Remote activity monitoring system OTHER

The home-based sensor technology of eNeighbor relies on multiple, non-invasive and safe remote monitors (up to 6 sensors) that can alert family caregivers and/or health professionals to potentially negative situations that lead to adverse outcomes (e.g., wandering, falls, incomplete activity of daily living tasks). The technology platform of eNeighbor relies on wireless infrastructure that allows for remote monitoring via alerts that are communicated to the family caregiver's or nurse care manager's personal computers or handheld devices. The Alerts that are generated from the sensors detected abnormal motion or activity are sent to the family caregiver as well as a nurse care manager that monitors the real-time information generated by the eNeighbor sensors.

Also known as: eNeighbor

Remote activity monitoring

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The person with ADRD must be English speaking;
• The person with ADRD must have a physician diagnosis of ADRD (Alzheimer's disease, Lewy Body disease, fronto-temporal dementia, or stroke/vascular dementia; mild cognitive impairment only)
• The person with ADRD must not be currently receiving care or case management services;
• The person with ADRD must be 55 years of age and over;
• The caregiver of persons with ADRD must be English speaking;
• The caregiver of persons with ADRD must be 21 years of age and over;
• The caregiver of persons with ADRD must self-identify as someone who provides help to the person with ADRD because of their cognitive impairments;
• The caregiver of persons with ADRD must self-identify as the person most responsible for providing hands-on care to the person with ADRD;
• The caregiver of persons with ADRD must plan to remain in the area for at least 18 months in order to reduce possible loss to follow-up; and
• The caregiver of persons with ADRD must indicate a willingness to use eNeighbor.

Sponsors & Collaborators

• University of Minnesota: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Related Publications (4)

• Mitchell LL, Peterson CM, Rud SR, Jutkowitz E, Sarkinen A, Trost S, Porta CM, Finlay JM, Gaugler JE. "It's Like a Cyber-Security Blanket": The Utility of Remote Activity Monitoring in Family Dementia Care. J Appl Gerontol. 2020 Jan;39(1):86-98. doi: 10.1177/0733464818760238. Epub 2018 Mar 4.

  PMID: 29504488 BACKGROUND

• Zmora R, Mitchell LL, Bustamante G, Finlay J, Nkimbeng M, Gaugler JE. Dementia Caregivers' Experiences and Reactions to Remote Activity Monitoring System Alerts. J Gerontol Nurs. 2021 Jan 1;47(1):13-20. doi: 10.3928/00989134-20201208-03.

  PMID: 33377980 BACKGROUND

• Gaugler JE, Zmora R, Mitchell LL, Finlay JM, Peterson CM, McCarron H, Jutkowitz E. Six-Month Effectiveness of Remote Activity Monitoring for Persons Living With Dementia and Their Family Caregivers: An Experimental Mixed Methods Study. Gerontologist. 2019 Jan 9;59(1):78-89. doi: 10.1093/geront/gny078.

  PMID: 29982413 RESULT

• Gaugler JE, Zmora R, Mitchell LL, Finlay J, Rosebush CE, Nkimbeng M, Baker ZG, Albers EA, Peterson CM. Remote activity monitoring for family caregivers of persons living with dementia: a mixed methods, randomized controlled evaluation. BMC Geriatr. 2021 Dec 18;21(1):715. doi: 10.1186/s12877-021-02634-8.

  PMID: 34922475 RESULT

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 11, 2018
• Study Start: April 1, 2014
• Primary Completion: March 31, 2020
• Study Completion: April 8, 2020
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share