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

NCT ID: NCT02606318

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Adjusted the challenge-skill balance

Intervention Type 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

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.

Group Type OTHER

Non-adjusted the challenge-skill balance

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* dementia
* visual impairment
Minimum Eligible Age

62 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harue Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ippei Yoshida

MS, OTR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tetsushi Nonaka, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Graduate School of Human Development and Environment

References

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Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.

Reference Type BACKGROUND
PMID: 20334633 (View on PubMed)

Hirao K, Kobayashi R, Okishima K, Tomokuni Y. Flow experience and health-related quality of life in community dwelling elderly Japanese. Nurs Health Sci. 2012 Mar;14(1):52-7. doi: 10.1111/j.1442-2018.2011.00663.x. Epub 2012 Jan 30.

Reference Type BACKGROUND
PMID: 22288733 (View on PubMed)

Other Identifiers

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YIPPE-1

Identifier Type: -

Identifier Source: org_study_id