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临床试验/NCT04796415
NCT04796415已完成不适用

Daily Engagement in Meaningful Activities Professional (DEMA-Pro) Intervention for Seniors With Subjective Cognitive Decline and Living at Home

Indiana University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Physical Function

研究概览

简要总结

More than 4.4 million patients receive home health services following discharge from the hospital or rehabilitation facility. A substantial number (70%) are older adults with subjective cognitive decline (SCD), an early clinical sign of Alzheimer's disease and related dementia. SCD is associated with diminished activity performance, poor quality-of-life and other adverse health outcomes (e.g., depressive symptoms). Home health patients with SCD often require more time, structure, and guidance to complete tasks and adjust to new skills and environments. Support is especially important during this high-risk period of transition between care settings. We propose a new home health care delivery model in partnership with Kindred at Home (KAH), a division of Humana that encompasses 400 programs across 40 states. DEMA-Pro builds on five preliminary studies that demonstrated high feasibility, acceptability, and positive preliminary effects on health outcomes (physical function, mood, and QoL). DEMA-Pro will be refined for delivery by home health services staff to patients with SCD and their informal caregivers. The overall goal of this research will be to conduct a pragmatic cluster randomized controlled trial (RCT) of DEMA-Pro to improve outcomes in-home health service patients with SCD. In the current R61 pilot phase, we will establish the trial's organizational structure and processes and pilot test DEMA-Pro in 4 home health services sites. In a subsequent trial, we plan to conduct a full pragmatic RCT in a group of Kindred KAH sites comparing DEMA-Pro to usual care. Consistent with the spirit of a pragmatic trial, we will use existing data sources including electronic Medicare OASIS (Outcome and Assessment Information Set) data, and QoL to characterize the cohort and measure outcomes. Thus, the focus of the pilot phase will be to ensure all processes are in place to conduct the subsequent RCT.

Aim 1. Establish the organizational infrastructure and programmatic processes needed to conduct a pragmatic cluster-randomized control trial of the DEMA-Pro intervention versus usual care. A Steering Committee will lead the project and coordinate the activities of 3 Work Groups: Regulatory and Operations; DEMA-Pro Intervention Protocol; and Data Management and Analysis.

Aim 2. Pilot test the DEMA-Pro training protocol in 4 KAH North Region locations and refine as indicated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 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

结局指标

主要结局

Physical Function

时间窗: Baseline to 6 weeks

Change in Physical Function measured by the Outcome and Assessment Information Set Data of Instructive Activities of Daily Living Scale (OASIS-D, IADLs Scale M1800s ).The ADL/IADL composite score ranges from 0 (total independence) to 9 (totally dependent/unable to complete). Higher score represent greater dependence.

次要结局

  • Sense of Well-Being(1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days)
  • Depression(1 week before DEMA-Pro intervention and post-DEMA-Pro program within 10 days)
  • Hospitalization Rate(One year after completing the intervention)
  • Nursing Home Transfers(One year after intervention)
  • Number, Types of ER Visits(One year after completing the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yvonne Lu

Professor

Indiana University

研究点 (2)

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