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临床试验/NCT03505619
NCT03505619已完成不适用

Evaluation of an Intervention Program Addressing Reablement Services in a Swedish Context (ASSIST 1.0) - A Protocol for a Feasibility Study

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年11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
20
试验地点
1
主要终点
Change in Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

Reablement holds a potential to become a new rehabilitation model and has been implemented in some western countries including Norway and Denmark. At present, there is a lack of scientific evidence for the effectiveness of reablement and lack of an explicit theoretical underpinning, leading to a gap in knowledge. Trends show, however, that reablement is beneficial for the person and their significant others, increasing quality of life. There is a need for further investigation of the effects among community-dwelling adults in terms of clinical and economic outcomes. This research project will investigate the effectiveness of reablement including smart products (digitally based) (ASSIST) to facilitate and manage reablement services in home-dwelling adults compared with standard home help services in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs.

Methods and analysis: This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention program as the fidelity, reach and dose, and potential outcomes by using a pre-post test design involving an intervention group and a control group (n=30). All participants will be living at home and with a need of home care services. Qualitative interviews among home care providers delivering ASSIST and older adults and their significant others receiving the intervention will be conducted to explore aspects affecting the intervention.

Ethics and dissemination: The results will form the base for refinement of the "ASSIST" program and planning of a large-scale randomized, controlled trial investigating the effect of the program on quality of life as physical health, mental well-being, conditions for social community when focusing on supporting the older person's to meaningful everyday life. Dissemination will include peer-reviewed publications and presentations at national and international conferences.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

The older adults will be included if they fulfil the following inclusion criteria a) ≥65 years or older and live at home, b) home care has been granted and the user is deemed not to need home rehabilitation performed by rehabilitation staff, c) two or more identified challenges in everyday activities that can benefit from everyday rehabilitation, d) are able to understand and express themselves in Swedish. One or more of the reasons will result in exclusion from the study: have cognitive limitations that make reablement unappropriate, in need of care in institutional dwelling or are terminally ill ,the older adults have had home help services more than three years.

When the older person in either the intervention or control group agrees to be involved in the study, they will be asked if they could consider involving a significant other.

The home care providers delivering ASSIST 1.0 or the ordinary home care will be included consisting of 8-10 staff from each group.

入排标准

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

入选标准

  • ≥65 years or older and live at home,
  • home care has been granted and the user is deemed not to need home rehabilitation performed by rehabilitation staff,
  • two or more identified challenges in everyday activities that can benefit from everyday rehabilitation,
  • are able to understand and express themselves in Swedish.

排除标准

  • have cognitive limitations that make reablement unappropriate,
  • in need of care in institutional dwelling or are terminally ill ,
  • the older adults have had home help services more than three years.

结局指标

主要结局

Change in Canadian Occupational Performance Measure (COPM)

时间窗: Change between baseline and 8 to 10 weeks post baseline.

Measuring the older adults' self-perception of activity performance and satisfaction within the areas of self care, productivity and leisure, measured on a 1-10 scale, where 10 represents most satsified and highest performance ranking.

次要结局

  • Change in Katz ADL extended scale(Change between baseline and 8 to 10 weeks post baseline.)
  • Frenchay Activity Index (FAI)(Change between baseline and 8 to 10 weeks post baseline.)
  • Change in Barthel Index(Change between baseline and 8 to 10 weeks post baseline.)
  • EQ5-D(Change between baseline and 8 to 10 weeks post baseline.)
  • Change in Sense of Coherence(Change between baseline and 8 to 10 weeks post baseline.)
  • The Swedish version of the General Self -Efficacy Scale)(GSE)(Change between baseline and 8 to 10 weeks post baseline.)
  • Hospital Anxiety and Depression Scale (HAD)(Change between baseline and 8 to 10 weeks post baseline.)
  • Mental Health Continuum -short form, Swedish version (MHC-SF)(Change between baseline and 8 to 10 weeks post baseline.)
  • Reintegration of Normal Living Index- (RNL)(Change between baseline and 8 to 10 weeks post baseline.)

研究者

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

Susanne Guidetti

Principal Investigator, PhD

Karolinska Institutet

研究点 (1)

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