- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304158
Community Based Management of Diabetes in Nepal (COBIN-D)
August 12, 2020 updated by: Bishal Gyawali, University of Aarhus
Community Based Intervention for Management of Diabetes in Nepal (COBIN-D): A Cluster Randomised Controlled Trial
Type 2 diabetes is the largest growing concern across the globe, and this is particularly apparent in developing countries, including Nepal.
Despite the growing burden and chronic nature of diabetes, prevention and control of this disease is far from adequate setting in Nepal.
Moreover, there is lack of evidence on effectiveness and affordability of a population approach on reducing blood glucose level among diabetes persons.
The main aim of this study is to determine the effect of Female Community Health Volunteers' (FCHVs)-led family-based health education and screening on blood sugar level in adults at community level in Nepal.
This is a community-based cluster randomized controlled trial involving family based health education through FCHVs in Nepal.
People ≥25 years of age listed in the Community-Based Management of Hypertension (COBIN) study and who were diabetics are eligible for eligible for participation in the study.
FCHVs will conduct family based health education and fasting blood glucose measurements in the treatment arm vs not any interventions in the control arm.
Independent assessors will conduct the baseline and end line assessment of the intervention.
Intention to treat analysis and per protocol analysis will be used in analysis to detect significant differences between treatment and control group participants at baseline and follow up.
For individual outcomes, proportions will be compared using Chi-square test and continuous measures will be compared using t-tests.
Random effect mixed regression analysis will be adjusted for age and sex.
Since randomisation will be at the cluster level in the study, a random-effect model will be used to account for clustering effect.
Effectiveness of the intervention will be tested by analysis of covariance, which will allow us to adjust for baseline differences between groups.
It is anticipated that the study can give valuable information regarding effectiveness, acceptability, and feasibility of an innovative way to improve diabetes management.
Assessing the FCHVs' ability to address diabetes may contribute to develop a policy that can be scaled-up to a national level.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
224
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pokhara, Nepal
- A semi-urban area of Pokhara-Lekhnath Metropolitan City of Nepal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Those ≥25 years of age and listed in the COBIN study
- Those who participated in our prevalence study
- Those who give consent to participate in our intervention study
- Those who do not have any plan to migrate from the study area for at least 1 year
- Those who are non-pregnant women
- Those who are not severely ill
Exclusion Criteria:
- Those who do not give consent
- Those who are pregnant women
- Those who are severely ill
- Those who have plans to migrate from the study area within 1 year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FCHV visit-diabetes
|
FCHVs will visit selected households 3 times a year for providing health promotion messages and measure the blood glucose
|
No Intervention: FCHV no visit-diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean fasting blood glucose level
Time Frame: 1 year
|
Change in mean fasting blood glucose level in diabetes populations
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gyawali B, Sharma R, Mishra SR, Neupane D, Vaidya A, Sandbaek A, Kallestrup P. Effectiveness of a Female Community Health Volunteer-Delivered Intervention in Reducing Blood Glucose Among Adults With Type 2 Diabetes: An Open-Label, Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2035799. doi: 10.1001/jamanetworkopen.2020.35799.
- Gyawali B, Neupane D, Vaidya A, Sandbaek A, Kallestrup P. Community-based intervention for management of diabetes in Nepal (COBIN-D trial): study protocol for a cluster-randomized controlled trial. Trials. 2018 Oct 22;19(1):579. doi: 10.1186/s13063-018-2954-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
January 31, 2019
Study Registration Dates
First Submitted
October 3, 2017
First Submitted That Met QC Criteria
October 3, 2017
First Posted (Actual)
October 6, 2017
Study Record Updates
Last Update Posted (Actual)
August 13, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUBIS123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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