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Completed

NCT Number: NCT02606318

Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life

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.

Completed

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Key information

Conditions

Elderly

Age range

62 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • dementia
  • visual impairment

Treatment and study plan

Adjusted the challenge-skill balance

Other

In the first session of occupational therapy, the therapist assessed the client's problems in daily living using the Canadian Occupational Performance Measure. Based on the problems identified, an activity that could be supported in day care was selected. In the second session, the client performed the selected activity, and then the challenge and skill levels of the activity were evaluated. Based on these levels, adjustment of the challenge-skill balance in the activity was attempted. Occupational therapy consisted of 10 sessions of 20 minutes held over about 10 weeks

Non-adjusted the challenge-skill balance

Other

The first and second sessions were conducted in the same way as for the experimental group, except that the therapists were not informed of the client's subjective perception of the challenge and skill levels for the activity. From the third session, the therapists simply assessed the client's performance and conducted the therapy in the normal manner for the day care center, following the general guidelines for occupational therapy practice

Primary outcomes

  1. Change in the EuroQol-5 Dimension questionnaire

    Time frame: 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).

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

    Time frame: 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.

Secondary outcomes

  1. Change in the Flow State Scale for Occupational Tasks questionnaire

    Time frame: Baseline and 10 weeks

    Flow State Scale for Occupational Tasks is a scale that can measure a patient's flow state in a clinical situation such as occupational therapy

  2. Change in the Canadian Occupational Performance Measure questionnaire

    Time frame: Baseline and 10 weeks

    Canadian Occupational Performance Measure assesses client's self-perception of their occupational performance

Sponsors and collaborators

Lead sponsor

Harue Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 17, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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