NCT03783598

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

December 14, 2018

Last Update Submit

February 14, 2020

Conditions

Keywords

Diabetes MellitusProblem SolvingOccupational TherapyHealthy LifestyleOccupational PerformancePerson-CenteredOccupation Based

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

EXPERIMENTAL

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

control group

NO INTERVENTION

Control 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.

Also known as: self management
intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

Gamze Ekici Çağlar

Ankara, 06100, Turkey (Türkiye)

Location

Zeynep Bahadır Ağce

Istanbul, 34674, Turkey (Türkiye)

Location

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: 29552422BACKGROUND
  • 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.

    PMID: 12763713BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • ZEYNEP B BAHADIR AGCE, PHD

    occupational therapy

    STUDY DIRECTOR

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
Model Details: 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.
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

Locations