Diabetes Mellitus, Group Meetings
Conditions
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.
Interventions
BEHAVIORALgroup care with Empowerment model
Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in in Hba1c levels | one year from date of randomization | Collection of data at start and after one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in non HDL Cholesterol | one year from date of randomization | Collection of data at start and end of study from electronic files |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in number of outpatients visits | one year from date of randomization | Collection of data at start and after one year |
| change in number in hospital admission | one year from date of randomization | Collection of data at start and end of study from electronic files |
Outcome results
None listed