Clinical trial NCT01596244: Jordan Diabetes Microclinic Project
Official title: Pilot and Expansion Project for the Jordan Diabetes Microclinic Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type II
Keywords: Diabetes Mellitus, Type II
Disease management
Chronic disease
Prevention and control
Education
Lead sponsor: Microclinic International
Sponsor class: OTHER
Collaborators: name: Ministry of Health Jordan
name: Royal Health Awareness Society (RHAS), Jordan
First posted: 2012-05-10
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Weight (kg)
timeFrame: Baseline, 4 months (intervention), and 12 months (post-intervention)
Secondary outcomes:
measure: Fasting Blood Glucose (mg/dl)
timeFrame: Baseline, 4 months, 12 months
measure: Hemoglobin A1c (%, HBA1c)
timeFrame: Baseline, 4 months, 12 months
measure: Body Mass Index (kg/m2)
timeFrame: Baseline, 4 months, 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Ein El-Basha Ministry of Health Center
city: Amman
country: Jordan
facility: Jabl Nasr Ministry of Health Center
Study officials:
affiliation: Microclinic International
name: Daniel Zoughbie, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Eric Ding, PhD
role: PRINCIPAL_INVESTIGATOR
References: