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A Proactive Health Monitoring Intervention for Dementia Caregivers

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Alzheimer Disease
Dementia

Treatments

Other: Remote activity monitoring system

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03665909
R18HS022836 (U.S. AHRQ Grant/Contract)
1401547541

Details and patient eligibility

About

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.

Full 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.

Enrollment

179 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

179 participants in 2 patient groups

Remote activity monitoring
Experimental group
Description:
Receive the remote activity monitoring system (i.e., "eNeighbor;" see intervention description) over an 18-month period.
Treatment:
Other: Remote activity monitoring system
Control
No Intervention group
Description:
Control participants do not receive the remote activity monitoring intervention.

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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