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临床试验/NCT02606318
NCT02606318已完成不适用

Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life: A Randomized Controlled Trial

Harue Hospital0 个研究点目标入组 56 人开始时间: 2013年12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
56
主要终点
Change in the EuroQol-5 Dimension questionnaire

研究概览

简要总结

The purpose of this study was to clarify the effects on health-related QOL of occupational therapy involving the adjustment of challenge-skill balance in the activity of elderly clients.

详细描述

This study was single-blind, randomized controlled trial. Clients were randomly assigned by blocked randomization (block size 4) to either the experimental group (occupational therapy that included assessment and adjustment of the challenge-skill balance of the activities) or to the control group (occupational therapy as normally conducted at the day care center). Randomization was stratified by sex and EuroQol visual analogue scale, resulting in four layers. The primary outcome was change in health-related quality of life after 10 sessions of occupational therapy. Clients were assessed before the intervention (pre-test) and after the 10th session (post-test). Significant differences were observed in the EuroQol-5 Dimension (EQ-5D) score and in the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) scores for general health, physical functioning , and vitality.

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
Single (Participant)

入排标准

年龄范围
62 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age >60 years
  • •occupational therapy at the center for >3 months

排除标准

  • •visual impairment

研究组 & 干预措施

Adjusted the challenge-skill balance

Experimental

This group received 10-session occupational therapy with adjustment of challenge-skill balance.This intervention aimed at improving the skill level for the activity has started once the balance were balanced.

干预措施: Adjusted the challenge-skill balance (Other)

Non-adjusted the challenge-skill balance

Other

This group received 10-session occupational therapy without adjustment of challenge-skill balance. That is conducted the therapy in the normal manner for the day care center.

干预措施: Non-adjusted the challenge-skill balance (Other)

结局指标

主要结局

Change in the EuroQol-5 Dimension questionnaire

时间窗: Baseline and 10 weeks

The EQ-5D defines health in five dimensions (mobility, self-care, usual activities, pain and discomfort, and anxiety or depression). The EQ-5D also has a visual analogue scale (EQ-VAS) that enables self-assessment on a scale from 0 (worst possible health) to 100 (best possible health).

Change in the Medical Outcome Study 8-Item Short-Form Health Survey questionnaire

时间窗: Baseline and 10 weeks

The SF-8 encompasses eight domains: general health, physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, and mental health, which can be combined to yield a physical component summary score and a mental component summary score.

次要结局

  • Change in the Canadian Occupational Performance Measure questionnaire(Baseline and 10 weeks)
  • Change in the Flow State Scale for Occupational Tasks questionnaire(Baseline and 10 weeks)

研究者

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

Ippei Yoshida

MS, OTR

Harue Hospital

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