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Clinical Trials/NCT03783598
NCT03783598
Completed
Not Applicable

Person-Centered, Occupation Based Intervention Program Supported With Problem-Solving Therapy for Type 2 Diabetes

Uskudar University2 sites in 1 country76 target enrollmentDecember 2, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Uskudar University
Enrollment
76
Locations
2
Primary Endpoint
Canada activity performance measure (COPM)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study was conducted to investigate the effect of a person-centered, occupation-based intervention program supported with problem-solving strategy in individuals with type 2 diabetes (T2D).

Method: The study was a randomized controlled trial, that included intervention (n=33) and control group (n=34), between the ages of 18 and 65 years.

Detailed Description

It was planned as a single-blind, randomized controlled study with 3-month follow-up in adults. A total of 67 subjects were randomly allocated to the intervention (n=33) or the control group (n=34). This program prepared with consider to meaningful activities for individual and overcome to barriers via problem solving. That was designed as 6 modules including evaluations, diabetes education and problem-solving therapy. Each module was implemented at least 1 session per week, about 60 minutes, and was arranged according to individual needs.

Registry
clinicaltrials.gov
Start Date
December 2, 2015
End Date
March 27, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uskudar University
Responsible Party
Principal Investigator
Principal Investigator

ZEYNEP BAHADIR AGCE

Assistant professor

Uskudar University

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of type 2 diabetes
  • Able to read and write turkish

Exclusion Criteria

  • Mental disorder

Outcomes

Primary Outcomes

Canada activity performance measure (COPM)

Time Frame: Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.

COPM, measure self-perceived change in problem on occupational performance and satisfaction over time. The COPM enable individuals to identify and prioritize everyday issues that restrict or impact their performance in everyday living. In the first step, occupational therapist interviews with client determine what the individual has done in his/her routine, what he/she wants to do or can not to do in their self-care, productivity and free time. Secondly the client to rate, on a scale of 1 to 10, the importance of each activity. Then confirming with the client the 5 most important problems and record. The client to rate each problem on performance and satisfaction, then calculate the total scores. Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing by the number of problems. At reassessment,the client scores each problem again for performance and satisfaction. Calculate the new scores and the change score.

Secondary Outcomes

  • The diabetes empowerment scale (DES)(Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.)
  • The Brief COPE(Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.)
  • WHO-five well-being index (WHO-5)(Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.)
  • Demographic questionnaire(Before the intervention)

Study Sites (2)

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