- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01596244
Jordan Diabetes Microclinic Project
Pilot and Expansion Project for the Jordan Diabetes Microclinic Project
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Amman, Jordan
- Ein El-Basha Ministry of Health Center
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Amman, Jordan
- Jabl Nasr Ministry of Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight (kg)
Time Frame: Baseline, 4 months (intervention), and 12 months (post-intervention)
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Change in weight overtime
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Baseline, 4 months (intervention), and 12 months (post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting Blood Glucose (mg/dl)
Time Frame: Baseline, 4 months, 12 months
|
Change in fasting blood glucose overtime
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Baseline, 4 months, 12 months
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Hemoglobin A1c (%, HBA1c)
Time Frame: Baseline, 4 months, 12 months
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Change in HBA1c overtime
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Baseline, 4 months, 12 months
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Body Mass Index (kg/m2)
Time Frame: Baseline, 4 months, 12 months
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Change in body mass index overtime
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Baseline, 4 months, 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Zoughbie, DPhil, Microclinic International
- Principal Investigator: Eric Ding, PhD, Harvard University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WDF07-231
- LT07-135 (International Diabetes Federation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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