Clinical trial NCT03783598: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Occupational Therapy
Keywords: Diabetes Mellitus
Problem Solving
Occupational Therapy
Healthy Lifestyle
Occupational Performance
Person-Centered
Occupation Based
Lead sponsor: Uskudar University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2018-12-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Cancer
* Mental disorder

Primary outcomes:
measure: Canada activity performance measure (COPM)
timeFrame: 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 outcomes:
measure: The diabetes empowerment scale (DES)
timeFrame: 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.
measure: The Brief COPE
timeFrame: 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.
measure: WHO-five well-being index (WHO-5)
timeFrame: 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.
measure: Demographic questionnaire
timeFrame: Before the intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gamze Ekici Çağlar
city: Istanbul
country: Turkey
facility: Zeynep Bahadır Ağce
Study officials:
affiliation: occupational therapy
name: ZEYNEP B BAHADIR AGCE, PHD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.