Clinical trial NCT04131257: Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal
Official title: Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal (NUCOD): Study Protocol for a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Continuum of care
Diabetes
Pre-diabetes
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 1236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycated Hemoglobin (HbA1c) level
timeFrame: Baseline, 6 months, 12 months
measure: Change in the incidence of diabetes among individuals with pre-diabetes
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Baseline, 6 months, 12 months
measure: Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol)
timeFrame: Baseline, 6 months, 12 months
measure: Change in Body Mass Index
timeFrame: Baseline, 6 months, 12 months
measure: Change in the "Reach" of people participating in the program
timeFrame: 6 months, 12 months
measure: Change in the "Adoption at the patient level" measured by the Summary of Diabetes Self-Care Activities Scale
timeFrame: Baseline, 6 months, 12 months
measure: Change in the "Adoption at the patient level" measured by the Diabetes Treatment Satisfaction Questionnaire
timeFrame: Baseline, 6 months, 12 months
measure: Change in the "Adoption at the clinic level"
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Kathmandu University School of Medical Sciences
name: Biraj M Karmacharya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.