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

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ClinicalTrials.gov Identifier: NCT02606318
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Ippei Yoshida, Harue Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Elderly Other: Adjusted the challenge-skill balance Other: Non-adjusted the challenge-skill balance Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life: A Randomized Controlled Trial
Study Start Date : December 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Adjusted the challenge-skill balance
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.
Other: Adjusted the challenge-skill balance
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
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.
Other: Non-adjusted the challenge-skill balance
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   62 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • dementia
  • visual impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606318


Sponsors and Collaborators
Harue Hospital
Investigators
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Principal Investigator: Tetsushi Nonaka, Ph.D Graduate School of Human Development and Environment

Publications:
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Responsible Party: Ippei Yoshida, MS, OTR, Harue Hospital
ClinicalTrials.gov Identifier: NCT02606318     History of Changes
Other Study ID Numbers: YIPPE-1
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Ippei Yoshida, Harue Hospital:
Occupational Therapy
Quality of Life