Group Versus Individual Care in Diabetes Clinic

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353376
• Other study ID #: JSMG-01
• Status: Completed
• Phase: N/A
• First received: November 2, 2017
• Last updated: November 22, 2017
• Start date: September 13, 2010
• Est. completion date: January 2, 2014

Study information

• Verified date: October 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2, 2014
• Est. primary completion date: January 2, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Group Meetings

Intervention

Behavioral:
• group care with Empowerment model
Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in number of outpatients visits	Collection of data at start and after one year	one year from date of randomization
Other	change in number in hospital admission	Collection of data at start and end of study from electronic files	one year from date of randomization
Primary	change in in Hba1c levels	Collection of data at start and after one year	one year from date of randomization
Secondary	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
Secondary	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
Secondary	change in non HDL Cholesterol	Collection of data at start and end of study from electronic files	one year from date of randomization