Jordan Diabetes Microclinic Project

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Jordan
Royal Health Awareness Society (RHAS), Jordan
Information provided by (Responsible Party):
Microclinic International
ClinicalTrials.gov Identifier:
NCT01596244
First received: May 9, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

The purpose of the study is to provide participants in economically depressed areas of Jordan essential knowledge, practical skills, and intimate support groups—called microclinics—for managing their diabetes. Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular micro-clinic meetings.


Condition Intervention
Diabetes Mellitus, Type II
Behavioral: Microclinic

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot and Expansion Project for the Jordan Diabetes Microclinic Project

Resource links provided by NLM:


Further study details as provided by Microclinic International:

Primary Outcome Measures:
  • Weight (kg) [ Time Frame: Baseline, 4 months (intervention), and 12 months (post-intervention) ] [ Designated as safety issue: No ]
    Change in weight overtime


Secondary Outcome Measures:
  • Fasting Blood Glucose (mg/dl) [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
    Change in fasting blood glucose overtime

  • Hemoglobin A1c (%, HBA1c) [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
    Change in HBA1c overtime

  • Body Mass Index (kg/m2) [ Time Frame: Baseline, 4 months, 12 months ] [ Designated as safety issue: No ]
    Change in body mass index overtime


Enrollment: 2400
Study Start Date: April 2008
Study Completion Date: August 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microclinics training
Diabetic, pre-diabetic, or those with family members who are diabetic/pre-diabetic who participated in a 4 month long intervention with a focus on disease management, health behavior change, and social network supports in order to improve chronic disease risk factors.
Behavioral: Microclinic
Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular microclinic meetings.

Detailed Description:

The Global Microclinic Project seeks to empower people to prevent and manage diseases in economically depressed areas Jordan. The project seeks to more broadly link health education opportunities in the form of lectures and seminars with practical experience through workshops and hands-on learning, ultimately resulting in the creation of microclinics. Microclinics are intimate support groups of diabetic patients (2-8 per clinic) who meet in their homes and businesses in order to share the costs of maintaining medical monitoring equipment and supplies, come together to support one another in the management of diabetes, collectively utilize vital treatment options, and receive personalized screening, education and management tools from medical professionals.

The microclinics concept is ideal for the management of chronic disorders such as diabetes, a disease which requires ongoing education about diet and exercise and regular monitoring of health indices such as blood glucose levels and weight change. Indeed, the microclinics model has been established successfully in the West Bank specifically to combat diabetes. The goal here is to extend the model to Jordan and to establish microclinics in a collaborative effort with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 18 years old
  • Mentally competent
  • Have diabetes or pre-diabetes or brought a family member who was diabetic/pre-diabetic (Diabetes: Fasting blood glucose higher than 125 mg/dl; Pre-diabetes: Fasting blood glucose between 100 and 124 mg/dl.)

Exclusion Criteria:

  • They do not meet the above criteria
  • They are pregnant
  • They have significant medical complications that prevent them from making changes to diet or level of physical activity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596244

Locations
Jordan
Jabl Nasr Ministry of Health Center
Amman, Jordan
Ein El-Basha Ministry of Health Center
Amman, Jordan
Sponsors and Collaborators
Microclinic International
Ministry of Health, Jordan
Royal Health Awareness Society (RHAS), Jordan
Investigators
Principal Investigator: Daniel Zoughbie, DPhil Microclinic International
Principal Investigator: Eric Ding, PhD Harvard University
  More Information

Additional Information:
No publications provided

Responsible Party: Microclinic International
ClinicalTrials.gov Identifier: NCT01596244     History of Changes
Other Study ID Numbers: WDF07-231, LT07-135
Study First Received: May 9, 2012
Last Updated: November 7, 2012
Health Authority: Jordan: Ethical Committee

Keywords provided by Microclinic International:
Diabetes Mellitus, Type II
Disease management
Chronic disease
Prevention and control
Education

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014