Group Versus Individual Care in Diabetes Clinic

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Group Meetings
• Intervention / Treatment: Behavioral: group care with Empowerment model

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	one year from date of randomization

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Study Chair: Noa Naftali, MA, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2010
• Primary Completion (Actual): January 2, 2014
• Study Completion (Actual): January 2, 2014

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: JSMG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No