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临床试验/NCT03665909
NCT03665909已完成不适用

A Proactive Health Monitoring Intervention for Dementia Caregivers: The eNeighbor

University of Minnesota0 个研究点目标入组 179 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
179
主要终点
Nursing home utilization at 18 months for the person with ADRD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control

No Intervention

Control participants do not receive the remote activity monitoring intervention.

Remote activity monitoring

Experimental

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

干预措施: Remote activity monitoring system (Other)

结局指标

主要结局

Nursing home utilization at 18 months for the person with ADRD

时间窗: 18-months

Caregiver report of nursing home use at 18 months.

次要结局

  • Perceptions of change in caregiver self-efficacy(Baseline, 6-months, 12-months, 18-months)
  • Perceived acceptability/utility of remote activity monitoring at 6-, 12-, and 18-months(6-months, 12-months, 18-months)
  • Perceptions of change in caregiver competence(Baseline, 6-months, 12-months, 18-months)
  • Change in frequency/perceptions caregiver depressive symptom severity(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)

研究者

申办方类型
Other
责任方
Sponsor

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