Jordan Diabetes Microclinic Project

Diabetes Mellitus, Type II Clinical Trial

Official title:

Pilot and Expansion Project for the Jordan Diabetes Microclinic Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596244
• Other study ID #: WDF07-231
• Secondary ID: LT07-135
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: November 7, 2012
• Start date: April 2008
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: Microclinic International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: August 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

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.

Locations

Country	Name	City	State
Jordan	Ein El-Basha Ministry of Health Center	Amman
Jordan	Jabl Nasr Ministry of Health Center	Amman

Sponsors (3)

Lead Sponsor	Collaborator
Microclinic International	Ministry of Health, Jordan, Royal Health Awareness Society (RHAS), Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (kg)	Change in weight overtime	Baseline, 4 months (intervention), and 12 months (post-intervention)	No
Secondary	Fasting Blood Glucose (mg/dl)	Change in fasting blood glucose overtime	Baseline, 4 months, 12 months	No
Secondary	Hemoglobin A1c (%, HBA1c)	Change in HBA1c overtime	Baseline, 4 months, 12 months	No
Secondary	Body Mass Index (kg/m2)	Change in body mass index overtime	Baseline, 4 months, 12 months	No

External Links

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