NCT02606318

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 7, 2015

Last Update Submit

November 19, 2015

Conditions

Keywords

Occupational TherapyQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Change in the EuroQol-5 Dimension questionnaire

    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).

    Baseline and 10 weeks

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

    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.

    Baseline and 10 weeks

Secondary Outcomes (2)

  • Change in the Flow State Scale for Occupational Tasks questionnaire

    Baseline and 10 weeks

  • Change in the Canadian Occupational Performance Measure questionnaire

    Baseline and 10 weeks

Study Arms (2)

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.

Other: Adjusted the challenge-skill balance

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.

Other: Non-adjusted the challenge-skill balance

Interventions

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

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

Non-adjusted the challenge-skill balance

Eligibility Criteria

Age62 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • dementia
  • visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20334633BACKGROUND
  • 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.

    PMID: 22288733BACKGROUND

Study Officials

  • Tetsushi Nonaka, Ph.D

    Graduate School of Human Development and Environment

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS, OTR

Study Record Dates

First Submitted

November 7, 2015

First Posted

November 17, 2015

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

November 20, 2015

Record last verified: 2015-11