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Group Versus Individual Care in Diabetes Clinic

NCT ID: NCT03353376

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-13

Study Completion Date

2014-01-02

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Group Meetings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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group care with empowerment model

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

Group Type EXPERIMENTAL

group care with Empowerment model

Intervention Type BEHAVIORAL

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

individual usual care

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

Group Type ACTIVE_COMPARATOR

group care with Empowerment model

Intervention Type BEHAVIORAL

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

Interventions

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group care with Empowerment model

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noa Naftali, MA

Role: STUDY_CHAIR

Rabin Medical Center

Other Identifiers

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JSMG-01

Identifier Type: -

Identifier Source: org_study_id