AzTrials
AzTrials

DementiaNCT03665909

A Proactive Health Monitoring Intervention for Dementia Caregivers

A study testing Remote activity monitoring system in people with Dementia and Alzheimer Disease, run by University of Minnesota.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia, Alzheimer Disease
What is being tested?
Remote activity monitoring system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
No sites listed yet
Study dates
1 Apr 2014to 8 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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.

Who cannot join

  • ● Those who do not meet the above inclusion criteria.

About this study

Official title: A Proactive Health Monitoring Intervention for Dementia Caregivers: The eNeighbor

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.

Read the 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.
Being tested
Remote activity monitoring system
Medical subject headings
Dementia, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote activity monitoring systemOther

    Also called eNeighbor

    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.

Study groups in NCT03665909
Study groupRoleWhat they receive
Remote activity monitoringExperimentalReceive the remote activity monitoring system (i.e., "eNeighbor;" see intervention description) over an 18-month period.
Receives: Other: Remote activity monitoring system
ControlNo interventionControl participants do not receive the remote activity monitoring intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nursing home utilization at 18 months for the person with ADRD

    Caregiver report of nursing home use at 18 months.

    Measured: 18-months

Secondary outcomes (7)

  1. Perceptions of change in caregiver self-efficacy

    An 8-item survey measure of caregiver self-efficacy. Item responses range from 1 "very unconfident" to 5 "very confident." Scores are summed and can range from a score of 1 (low self-efficacy) to 40 (high self-efficacy).

    Measured: Baseline, 6-months, 12-months, 18-months

  2. Perceptions of change in caregiver competence

    The 7-item Short Sense of Competence Questionnaire (SSCQ), which assesses individuals' sense of capability in providing assistance to a relative with Alzheimer's disease or related dementias via survey report. Item responses range from 1 = strongly disagree to 5 = strongly agree. Item responses are summed, with a total score range of 5 to 35.

    Measured: Baseline, 6-months, 12-months, 18-months

  3. Perceptions of change in caregiver burden

    The 22-item Zarit Burden Interview self-report survey measure. Item responses range from 0 "never" to 4 "nearly always." Scores are summed and can range from a score of 0 (no burden) to 88 (high burden).

    Measured: Baseline, 6-months, 12-months, 18-months

  4. Perceptions of change in caregiver role captivity

    The 4-item role captivity measure assesses the involuntary aspects of the caregiving role. Item responses range from 1 = "not at all" to 4 = "very much." The total role captivity score is the sum of item responses with a range of 4 (no role captivity) to 16 (high role captivity).

    Measured: Baseline, 6-months, 12-months, 18-months

  5. Change in caregiver role overload

    The 3-item role overload survey measure ascertains caregivers' feelings of emotional and physical fatigue. Item responses range from 1 = "not at all" to 4 = "very much." The total role overload score is the sum iof item responses with a range of 4 (no role overload) to 16 (high role overload).

    Measured: Baseline, 6-months, 12-months, 18-months

  6. Change in frequency/perceptions caregiver depressive symptom severity

    The 20-item Center for Epidemiological Studies Depression (CES-D) survey measure is used to assess caregivers' depressive symptoms. Item responses range from 1 = "Rarely or none of the time (less than 1 day)" to 5 = "Most of the time (5-7 days)." The total CES-D score is summed, with a range of 20 (little to no depressive symptoms) to 100 (frequent depressive symptoms).

    Measured: Baseline, 6-months, 12-months, 18-months

  7. Perceived acceptability/utility of remote activity monitoring at 6-, 12-, and 18-months

    The Remote Activity Monitoring Review Checklist is administered to caregiving participants in the treatment condition at the 6-month, 12-month and 18-month follow-up survey intervals. The checklist consists of 21 self-report survey Likert scale items. Item responses range from 1 = strongly disagree to 5 = strongly agree. The total checklist score is averaged, with a score of 1 = the remote activity monitoring system was not well-received/accepted to 5 = the remote activity monitoring system was very well received/accepted.

    Measured: 6-months, 12-months, 18-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start1 Apr 2014
  3. Primary completion31 Mar 2020
  4. Study completion8 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03665909
Sponsor's protocol ID
1401547541
Other IDs
R18HS022836
Status last verified
Oct 2023
First submitted
4 Sep 2018
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29504488

  • 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.

    PubMed 33377980

  • 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.

    PubMed 29982413

  • 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.

    PubMed 34922475

Questions about this trial

What is this clinical trial studying?

A study testing Remote activity monitoring system in people with Dementia and Alzheimer Disease, run by University of Minnesota.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nursing home utilization at 18 months for the person with ADRD (time frame: 18-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03665909, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in