Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal
NCT ID: NCT04131257
Last Updated: 2019-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1236 participants
INTERVENTIONAL
2019-12-31
2020-12-31
Brief Summary
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Detailed Description
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We will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NUrse-led COntinuum of care for people with diabetes and pre-diabetes (NUCOD), with primary care centers (Outreach centers and Government health posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among pre-diabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis.
The results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and pre-diabetes individuals, and implementation outcomes for the organization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Continuum of care
Trained diabetes nurses will provide continuum of care to the participants that includes: conducting community awareness campaigns, screening programs, linkage to clinical care, community follow-up counseling and support for individuals with diabetes, and prevention programs for individuals with pre-diabetes.
Nurse-led Continuum of Care
This will be a nurse-led community level prevention program for individuals with diabetes and pre-diabetes, where participants in intervention group will receive nurse-led continuum of care while control group will receive usual diabetic care.
Usual care
The control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group.
Nurse-led Continuum of Care
This will be a nurse-led community level prevention program for individuals with diabetes and pre-diabetes, where participants in intervention group will receive nurse-led continuum of care while control group will receive usual diabetic care.
Interventions
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Nurse-led Continuum of Care
This will be a nurse-led community level prevention program for individuals with diabetes and pre-diabetes, where participants in intervention group will receive nurse-led continuum of care while control group will receive usual diabetic care.
Eligibility Criteria
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Inclusion Criteria
* with confirmed diagnosis of type II diabetes or prediabetes after our community screening process (i.e., newly diagnosed diabetes and prediabetes)
* is not planning to relocate outside of the current place of living in next 2 years
* is older than 18 years of age
Exclusion Criteria
* are diagnosed as type 1 diabetes
18 Years
ALL
Yes
Sponsors
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Kathmandu University School of Medical Sciences
OTHER
Responsible Party
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Biraj Man Karmacharya
Associate Professor
Principal Investigators
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Biraj M Karmacharya, PhD
Role: PRINCIPAL_INVESTIGATOR
Kathmandu University School of Medical Sciences
Central Contacts
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References
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Xu DR, Dev R, Shrestha A, Zhang L, Shrestha A, Shakya P, Hughes JP, Shakya PR, Li J, Liao J, Karmacharya BM. NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial. Trials. 2020 May 29;21(1):442. doi: 10.1186/s13063-020-04372-5.
Other Identifiers
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KathmanduUSMS
Identifier Type: -
Identifier Source: org_study_id
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