Person-Centered, Occupation Based Therapy for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783598
• Other study ID #: 569831°
• Status: Completed
• Phase: N/A
• Start date: December 2, 2015
• Est. completion date: March 27, 2018

Study information

• Verified date: February 2020
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 27, 2018
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes

• Able to read and write turkish

Exclusion Criteria:

• Cancer

• Mental disorder

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Occupational Therapy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gamze Ekici Çaglar	Ankara
Turkey	Zeynep Bahadir Agce	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Uskudar University	Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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 (i'm not doing this at all) to 4 (i'm doing this a lot), and min-max score range from 2 to 8.	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	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.	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	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)	Before the intervention