Group Versus Individual Care in Diabetes Clinic

Not Applicable

Completed

• Conditions: Group Meetings; Diabetes Mellitus
• Interventions: Behavioral: group care with Empowerment model

• Registration Number: NCT03353376
• Lead Sponsor: Rabin Medical Center

Brief Summary

In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.

Detailed Description

in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.

Study Timeline

• Study Start: 2010-09-13
• Primary Completion: 2014-01-02
• Study Completion: 2014-01-02
• Status Verified: 2017-10
• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-27
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of type 1 or type 2 diabetes
• Fluency in Hebrew
• Attendance at least for the second time at the diabetes clinic
• Follow up of at least one year by a general practitioner
• Willingness to participate in the study and to give informed consent.

Exclusion Criteria

• Uncontrolled psychiatric diseases
• Active cancer
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group care with empowerment model	group care with Empowerment model	4 group visits a year according to empowerment model in a tertiary diabetes clinic
individual usual care	group care with Empowerment model	individual visits according to disponibility in the diabetes clinic and needs of the patients

Primary Outcome Measures

Name	Time	Method
change in in Hba1c levels	one year from date of randomization	Collection of data at start and after one year

Secondary Outcome Measures

Name	Time	Method
change in scores of diabetes specific questionnaire	one year from date of randomization	Collection of data at start and end of study from electronic files
change in BMI in kg/m2	one year from date of randomization	Collection of data (weight in kg, height in meter) at start and end of study from electronic files
change in non HDL Cholesterol	one year from date of randomization	Collection of data at start and end of study from electronic files