Group Versus Individual Care in Diabetes Clinic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Group Versus Individual Care in Patients With Long Standing Type 1 and Type 2 Diabetes: Non Inferiority in a One Year Prospective Study in a Tertiary Diabetes Clinic

Conditions
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Diabetes Mellitus, Group Meetings

Intervention / Treatment
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* Behavioral: group care with Empowerment model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group care with empowerment model<br>4 group visits a year according to empowerment model in a tertiary diabetes clinic | Behavioral: group care with Empowerment model<br>* Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment<br>|
| Active Comparator: individual usual care<br>individual visits according to disponibility in the diabetes clinic and needs of the patients | Behavioral: group care with Empowerment model<br>* Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in in Hba1c levels | Collection of data at start and after one year | one year from date of randomization | 

Secondary Outcome Measures

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