Person-Centered, Occupation Based Therapy for Type 2 Diabetes

Sponsor

Uskudar University (Other)

Overall Status

Completed

CT.gov ID

NCT03783598

Collaborator

Hacettepe University (Other)

Enrollment

Locations

Arms

27.8

Actual Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Occupational Therapy	Behavioral: Person centered, occupation based intervention support with problem solving therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 2, 2015

Actual Primary Completion Date :

Feb 2, 2017

Actual Study Completion Date :

Mar 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group 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.	Behavioral: Person centered, occupation based intervention support with problem solving therapy 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. Other Names: self management
No Intervention: control group Control group had not any intervention we have an education to control group about diabetes and healthy life conditions.

Arm

Intervention/Treatment

Experimental: intervention group

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.

Behavioral: Person centered, occupation based intervention support with problem solving therapy

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.

Other Names:

self management

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

Canada activity performance measure (COPM) [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 Outcome Measures

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.]
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 [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 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) [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 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 [Before the intervention]
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)