Person-Centered, Occupation Based Therapy for Type 2 Diabetes
1 other identifier
interventional
76
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Dec 2015
Typical duration for not_applicable diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2018
CompletedFirst Submitted
Initial submission to the registry
December 14, 2018
CompletedFirst Posted
Study publicly available on registry
December 21, 2018
CompletedFebruary 18, 2020
February 1, 2020
1.2 years
December 14, 2018
February 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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 Arms (2)
intervention group
EXPERIMENTALThe 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
NO INTERVENTIONControl group had not any intervention we have an education to control group about diabetes and healthy life conditions.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of type 2 diabetes
- Able to read and write turkish
You may not qualify if:
- Cancer
- Mental disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uskudar Universitylead
- Hacettepe Universitycollaborator
Study Sites (2)
Gamze Ekici Çağlar
Ankara, 06100, Turkey (Türkiye)
Zeynep Bahadır Ağce
Istanbul, 34674, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 29552422BACKGROUNDHill-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.
PMID: 12763713BACKGROUNDHwang 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.
PMID: 23927025RESULTBahadir 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.
PMID: 32746841DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ZEYNEP B BAHADIR AGCE, PHD
occupational therapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
December 14, 2018
First Posted
December 21, 2018
Study Start
December 2, 2015
Primary Completion
February 2, 2017
Study Completion
March 27, 2018
Last Updated
February 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share