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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group care with empowerment model | Experimental | 4 group visits a year according to empowerment model in a tertiary diabetes clinic |
|
| individual usual care | Active Comparator | individual visits according to disponibility in the diabetes clinic and needs of the patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group care with Empowerment model | Behavioral | Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in in Hba1c levels | Collection of data at start and after one year | one year from date of randomization |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in number of outpatients visits | Collection of data at start and after one year | one year from date of randomization |
| change in number in hospital admission | Collection of data at start and end of study from electronic files |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noa Naftali, MA | Rabin Medical Center | Study Chair |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
| one year from date of randomization |