Group Versus Individual Care in Diabetes Clinic

Clalit Health Services

Status: Completed

Conditions: Diabetes Mellitus; Group Meetings

Treatments: Behavioral: group care with Empowerment model

Study type: Interventional

Funder types: Other

Identifiers

NCT03353376

JSMG-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

group care with empowerment model

Experimental group

Description:

4 group visits a year according to empowerment model in a tertiary diabetes clinic

Treatment:

Behavioral: group care with Empowerment model

individual usual care

Active Comparator group

Description:

individual visits according to disponibility in the diabetes clinic and needs of the patients

Treatment:

Behavioral: group care with Empowerment model