Clinical trial NCT03665909: A Proactive Health Monitoring Intervention for Dementia Caregivers
Official title: A Proactive Health Monitoring Intervention for Dementia Caregivers: The eNeighbor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2018-09-11
Enrollment: 179
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: In collaboration with a 15-member Community Advisory Board that includes community care providers, healthcare organizations, and ADRD caregivers themselves, the proposed 5-year project will build on the current efforts of The Lutheran Home Association (TLHA) to evaluate eNeighbor remote monitoring technology for persons with ADRD living in the community and their family caregivers. The Specific Aims are as follows:

1. To determine the efficacy of remote sensor technology over an 18-month period for 100 persons with ADRD and their caregivers randomly assigned to an eNeighbor treatment condition when compared to 100 usual care controls. The investigators hypothesize:

   Hx. 1) Significant (p \< .05) improvements in caregiver self-efficacy and sense of competence in managing a relative's ADRD; Hx. 2) Significant reductions in caregiver distress (e.g., subjective stress, or feelings of emotional fatigue and role entrapment; depressive symptoms); Hx. 3) Significant delay of or reductions in health transitions (falls, wandering) and service utilization (hospitalizations, nursing home admission) for persons with ADRD; and Hx. 4) Greater cost-effectiveness associated with a person with ADRD's health service use.
2. To "embed" evaluation components: a) during the randomized controlled evaluation through the administration of open-ended survey items to all ADRD caregivers in the eNeighbor treatment condition every 6 months to examine the utility of the remote health monitoring technology; and b) at the conclusion of the 18-month evaluation by purposively sampling 15 ADRD caregivers who reported positive acceptance on the embedded qualitative and quantitative 6-, 12-, and 18-month system reviews and 15 ADRD caregivers who reported low acceptance on the embedded qualitative and quantitative 6-, 12-, and 18-month system reviews to participate in semi-structured interviews. The interviews will help the research team determine why the health monitoring intervention was or was not efficacious; and
3. To engage stakeholders on a quarterly basis throughout the 5-year project with the goal of enhancing the utility (via community-based participatory approaches) and stakeholder-relevance of eNeighbor implementation and evaluation for family caregivers of persons with ADRD.

Eligibility criteria: INCLUSION

* 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.

EXCLUSION

● Those who do not meet the above inclusion criteria.

Primary outcomes:
measure: Nursing home utilization at 18 months for the person with ADRD
timeFrame: 18-months
Secondary outcomes:
measure: Perceptions of change in caregiver self-efficacy
timeFrame: Baseline, 6-months, 12-months, 18-months
measure: Perceptions of change in caregiver competence
timeFrame: Baseline, 6-months, 12-months, 18-months
measure: Perceptions of change in caregiver burden
timeFrame: Baseline, 6-months, 12-months, 18-months
measure: Perceptions of change in caregiver role captivity
timeFrame: Baseline, 6-months, 12-months, 18-months
measure: Change in caregiver role overload
timeFrame: Baseline, 6-months, 12-months, 18-months
measure: Change in frequency/perceptions caregiver depressive symptom severity
timeFrame: Baseline, 6-months, 12-months, 18-months
measure: Perceived acceptability/utility of remote activity monitoring at 6-, 12-, and 18-months
timeFrame: 6-months, 12-months, 18-months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.