Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal (NUCOD)

Kathmandu University School of Medical Sciences

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Nurse-led Continuum of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04131257

KathmanduUSMS

Details and patient eligibility

About

The study aims to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.

Full description

The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.

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.

Enrollment: 1,236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• with confirmed pre-existing type II diabetes and prediabetes at the time of our screening (i.e., pre-existing diabetes or prediabetes)
• 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 not psychologically capable of communication
• are diagnosed as type 1 diabetes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,236 participants in 2 patient groups

Continuum of care

Experimental group

Description:

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.

Treatment:

Behavioral: Nurse-led Continuum of Care

Usual care

Active Comparator group

Description:

The control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group.

Treatment:

Behavioral: Nurse-led Continuum of Care