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Jordan Diabetes Microclinic Project

Primary Purpose

Diabetes Mellitus, Type II

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Microclinic
Sponsored by
Microclinic International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type II focused on measuring Diabetes Mellitus, Type II, Disease management, Chronic disease, Prevention and control, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ein El-Basha Ministry of Health Center
  • Jabl Nasr Ministry of Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microclinics training

Arm Description

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.

Outcomes

Primary Outcome Measures

Weight (kg)
Change in weight overtime

Secondary Outcome Measures

Fasting Blood Glucose (mg/dl)
Change in fasting blood glucose overtime
Hemoglobin A1c (%, HBA1c)
Change in HBA1c overtime
Body Mass Index (kg/m2)
Change in body mass index overtime

Full Information

First Posted
May 9, 2012
Last Updated
November 7, 2012
Sponsor
Microclinic International
Collaborators
Ministry of Health Jordan, Royal Health Awareness Society (RHAS), Jordan
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1. Study Identification

Unique Protocol Identification Number
NCT01596244
Brief Title
Jordan Diabetes Microclinic Project
Official Title
Pilot and Expansion Project for the Jordan Diabetes Microclinic Project
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microclinic International
Collaborators
Ministry of Health Jordan, Royal Health Awareness Society (RHAS), Jordan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
Keywords
Diabetes Mellitus, Type II, Disease management, Chronic disease, Prevention and control, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microclinics training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Microclinic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight (kg)
Description
Change in weight overtime
Time Frame
Baseline, 4 months (intervention), and 12 months (post-intervention)
Secondary Outcome Measure Information:
Title
Fasting Blood Glucose (mg/dl)
Description
Change in fasting blood glucose overtime
Time Frame
Baseline, 4 months, 12 months
Title
Hemoglobin A1c (%, HBA1c)
Description
Change in HBA1c overtime
Time Frame
Baseline, 4 months, 12 months
Title
Body Mass Index (kg/m2)
Description
Change in body mass index overtime
Time Frame
Baseline, 4 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Zoughbie, DPhil
Organizational Affiliation
Microclinic International
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Ding, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ein El-Basha Ministry of Health Center
City
Amman
Country
Jordan
Facility Name
Jabl Nasr Ministry of Health Center
City
Amman
Country
Jordan

12. IPD Sharing Statement

Links:
URL
http://www.microclinics.org/
Description
Related Info

Learn more about this trial

Jordan Diabetes Microclinic Project

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