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Person-Centered, Occupation Based Therapy for Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2, Occupational Therapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Person centered, occupation based intervention support with problem solving therapy
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Problem Solving, Occupational Therapy, Healthy Lifestyle, Occupational Performance, Person-Centered, Occupation Based

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Cancer
  • Mental disorder

Sites / Locations

  • Gamze Ekici Çağlar
  • Zeynep Bahadır Ağce

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

The intervention group received problem solving therapy as 6 modules. Each module was included at least 1 session per week that is nearly 60 minutes, and the amount of weekly sessions was arranged according to the needs of the person.Individuals has an opportunity was provided for identify problems meaningful for themselves and to start their change from the activities they valued by using the COPM.

Control group had not any intervention we have an education to control group about diabetes and healthy life conditions.

Outcomes

Primary Outcome Measures

Canada activity performance measure (COPM)
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 Outcome Measures

The diabetes empowerment scale (DES)
DES measure the psychosocial self-efficacy of people with diabetes. The scale consists of three factors; managing the psychosocial aspects of diabetes (9 items), assessing dissatisfaction and readiness to change (9 items), setting and achieving diabetes goals (10 items). Each question on the diabetes empowerment scale scores between 1 (strongly disagree) to 5 (strongly agree). The total score of the scale, calculated by adding all of the item scores and dividing by 28. High score indicates that the levels of empowerment are high.
The Brief COPE
The Brief COPE assess coping style with stress. Brief COPE include 14 subscale such as self-distraction (items 1 and 19), active coping, (items 2 and 7), denial, (items 3 and 8), substance use, (items 4 and 11), use of emotional support, (items 5 and 15), use of instrumental support, (items 10 and 23), behavioral disengagement, (items 6 and 16),venting, (items 9 and 21), positive reframing, items 12 and 17), planning, (items 14 and 25),humor, (items 18 and 28). each options rate range from 1 (ı'm not doing this at all) to 4 (ı'm doing this a lot), and min-max score range from 2 to 8.
WHO-five well-being index (WHO-5)
The WHO-5 well being index was used to psychometrically sound measure of emotional well-being. The answer for each question are given considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The total score changes to ranges from 0 (absence of well-being) to 25 (maximum well-being). The raw score is multiplied by 4 to obtain a percentage score between 0 and 100. When the changes is 10% in raw score, that indicates a significant change.
Demographic questionnaire
Demographic questionnaire: At first all participants filled a questionnaire covering demographic form, which included the participant's age, gender, education, health habits (smoking, alcohol consumption, participation in sport) and body mass index (BMI)

Full Information

First Posted
December 14, 2018
Last Updated
February 14, 2020
Sponsor
Uskudar University
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03783598
Brief Title
Person-Centered, Occupation Based Therapy for Type 2 Diabetes
Official Title
Person-Centered, Occupation Based Intervention Program Supported With Problem-Solving Therapy for Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2, 2015 (Actual)
Primary Completion Date
February 2, 2017 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University
Collaborators
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Occupational Therapy
Keywords
Diabetes Mellitus, Problem Solving, Occupational Therapy, Healthy Lifestyle, Occupational Performance, Person-Centered, Occupation Based

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The problem solving therapy is an social cognitive therapy approach. And ıt support to solve meaningfull occupational performance problems realted to diabetes by invdividuals and this way, it helps to improve the self-management of diabetes.We used that with person centered perspective and support to person with education which was perspective of person environment occupation model.
Masking
Participant
Masking Description
The study population was 76 individuals whose diagnosis of type 2 diabetes. 9 volunteer individual gave up to participation without for various reasons in the process.That intervention grup (n=33) control group (n=34), between the ages of 18 to 65 years and volunteer individuals.
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
The intervention group received problem solving therapy as 6 modules. Each module was included at least 1 session per week that is nearly 60 minutes, and the amount of weekly sessions was arranged according to the needs of the person.Individuals has an opportunity was provided for identify problems meaningful for themselves and to start their change from the activities they valued by using the COPM.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Control group had not any intervention we have an education to control group about diabetes and healthy life conditions.
Intervention Type
Behavioral
Intervention Name(s)
Person centered, occupation based intervention support with problem solving therapy
Other Intervention Name(s)
self management
Intervention Description
This program that was developed from the occupational therapy perspective which is person centered and occupation based for T2D intervention was designed as 6 modules. The intervention group received person centered, occupation based intervention support with problem solving therapy as 6 modules. The control group had not any intervention, just had a education about effect of diabetes on life.
Primary Outcome Measure Information:
Title
Canada activity performance measure (COPM)
Description
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.
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.
Secondary Outcome Measure Information:
Title
The diabetes empowerment scale (DES)
Description
DES measure the psychosocial self-efficacy of people with diabetes. The scale consists of three factors; managing the psychosocial aspects of diabetes (9 items), assessing dissatisfaction and readiness to change (9 items), setting and achieving diabetes goals (10 items). Each question on the diabetes empowerment scale scores between 1 (strongly disagree) to 5 (strongly agree). The total score of the scale, calculated by adding all of the item scores and dividing by 28. High score indicates that the levels of empowerment are high.
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.
Title
The Brief COPE
Description
The Brief COPE assess coping style with stress. Brief COPE include 14 subscale such as self-distraction (items 1 and 19), active coping, (items 2 and 7), denial, (items 3 and 8), substance use, (items 4 and 11), use of emotional support, (items 5 and 15), use of instrumental support, (items 10 and 23), behavioral disengagement, (items 6 and 16),venting, (items 9 and 21), positive reframing, items 12 and 17), planning, (items 14 and 25),humor, (items 18 and 28). each options rate range from 1 (ı'm not doing this at all) to 4 (ı'm doing this a lot), and min-max score range from 2 to 8.
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.
Title
WHO-five well-being index (WHO-5)
Description
The WHO-5 well being index was used to psychometrically sound measure of emotional well-being. The answer for each question are given considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The total score changes to ranges from 0 (absence of well-being) to 25 (maximum well-being). The raw score is multiplied by 4 to obtain a percentage score between 0 and 100. When the changes is 10% in raw score, that indicates a significant change.
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.
Title
Demographic questionnaire
Description
Demographic questionnaire: At first all participants filled a questionnaire covering demographic form, which included the participant's age, gender, education, health habits (smoking, alcohol consumption, participation in sport) and body mass index (BMI)
Time Frame
Before the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of type 2 diabetes Able to read and write turkish Exclusion Criteria: Cancer Mental disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZEYNEP B BAHADIR AGCE, PHD
Organizational Affiliation
occupational therapy
Official's Role
Study Director
Facility Information:
Facility Name
Gamze Ekici Çağlar
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Zeynep Bahadır Ağce
City
Istanbul
ZIP/Postal Code
34674
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29552422
Citation
Weigensberg MJ, Vigen C, Sequeira P, Spruijt-Metz D, Juarez M, Florindez D, Provisor J, Peters A, Pyatak EA. Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Glob Adv Health Med. 2018 Mar 8;7:2164956118761808. doi: 10.1177/2164956118761808. eCollection 2018.
Results Reference
background
PubMed Identifier
12763713
Citation
Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.
Results Reference
background
PubMed Identifier
23927025
Citation
Hwang JE, Truax C, Claire M, Caytap AL. Occupational therapy in diabetic care-areas of need perceived by older adults with diabetes. Occup Ther Health Care. 2009;23(3):173-88. doi: 10.1080/07380570902950259.
Results Reference
result
PubMed Identifier
32746841
Citation
Bahadir Agce Z, Ekici G. Person-centred, occupation-based intervention program supported with problem-solving therapy for type 2 diabetes: a randomized controlled trial. Health Qual Life Outcomes. 2020 Aug 3;18(1):265. doi: 10.1186/s12955-020-01521-x.
Results Reference
derived

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Person-Centered, Occupation Based Therapy for Type 2 Diabetes

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