Group Versus Individual Care in Diabetes Clinic

NCT03353376 | Completed

• 1 other identifier: JSMG-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Group Meetings

Outcome Measures

Primary Outcomes (1)

• change in in Hba1c levels

  Collection of data at start and after one year

  one year from date of randomization

Secondary Outcomes (3)

• change in scores of diabetes specific questionnaire

  one year from date of randomization

• change in BMI in kg/m2

  one year from date of randomization

• change in non HDL Cholesterol

  one year from date of randomization

Other Outcomes (2)

• change in number of outpatients visits

  one year from date of randomization

• change in number in hospital admission

  one year from date of randomization

Study Arms (2)

group care with empowerment model

EXPERIMENTAL

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

Behavioral: group care with Empowerment model

individual usual care

ACTIVE COMPARATOR

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

Behavioral: group care with Empowerment model

Interventions

group care with Empowerment model BEHAVIORAL

Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment

group care with empowerment model; individual usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled psychiatric diseases
• Active cancer
• Pregnancy

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Noa Naftali, MA

  Rabin Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 27, 2017
• Study Start: September 13, 2010
• Primary Completion: January 2, 2014
• Study Completion: January 2, 2014
• Last Updated: November 27, 2017

Record last verified: 2017-10