An interventional study of Remote activity monitoring system in Dementia and Alzheimer Disease, sponsored by University of Minnesota. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by University of Minnesota · Not applicable, Interventional, and Supportive care
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.
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:
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.
2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 179 is above the median of 83 across 1,669 interventional studies indexed under Dementia.
Browse Dementia studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
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EXCLUSION
● Those who do not meet the above inclusion criteria.
Receive the remote activity monitoring system (i.e., "eNeighbor;" see intervention description) over an 18-month period.
Other: Remote activity monitoring system
Control participants do not receive the remote activity monitoring intervention.
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
Nursing home utilization at 18 months for the person with ADRD
Caregiver report of nursing home use at 18 months.
Time frame: 18-months
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).
Time frame: Baseline, 6-months, 12-months, 18-months
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.
Time frame: Baseline, 6-months, 12-months, 18-months
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).
Time frame: Baseline, 6-months, 12-months, 18-months
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).
Time frame: Baseline, 6-months, 12-months, 18-months
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).
Time frame: Baseline, 6-months, 12-months, 18-months
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).
Time frame: Baseline, 6-months, 12-months, 18-months
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.
Time frame: 6-months, 12-months, 18-months
No study locations are listed for this record.
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Plan to share: No
Ran from Apr 2014 to primary completion in Mar 2020, 71 months.
Of 835 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 71 months is above that.
Counting every sponsor, half of 875 studies reached it within 24 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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