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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Nurse-led Continuum of Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuum of care<br>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. | Behavioral: Nurse-led Continuum of Care<br>* 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.<br>|
| Active Comparator: Usual care<br>The control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group. | Behavioral: Nurse-led Continuum of Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycated Hemoglobin (HbA1c) level | The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway) | Baseline, 6 months, 12 months | 
| Change in the incidence of diabetes among individuals with pre-diabetes | Electronic Health Record will be used to measure the incidence of diabetes | 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure | The blood pressure will be measured using mean of three measurements of systolic and diastolic blood pressure, using a Microlife automatic blood pressure measuring device | Baseline, 6 months, 12 months | 
| Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol) | LDL and HDL will be measured using the elimination method (Dialab, Austria); triglyceride using GPO-PAP (Dialab, Austria); and total cholesterol using CHOD-PAP (Dialab, Austria) | Baseline, 6 months, 12 months | 
| Change in Body Mass Index | Body Mass Index will be calculated as weight in kilograms divided by height in meters squared | Baseline, 6 months, 12 months | 
| Change in the Reach of people participating in the program | Reach will be measured by the number of people participating in the program divided by the number of people eligible to be recruited into the program | 6 months, 12 months | 
| Change in the Adoption at the patient level measured by the Summary of Diabetes Self-Care Activities Scale | Adoption at the patient level will be measured by the proportion of people adherent to the clinical advice in lifestyle and self-care. These will be measured by the self-reported Summary of Diabetes Self-Care Activities scale. Five areas are assessed by the scale: Diet, Exercise, Blood-glucose testing, Foot care, and Smoking status. Scale of 0-7 is used. Higher the score better is the outcome. | Baseline, 6 months, 12 months | 
| Change in the Adoption at the patient level measured by the Diabetes Treatment Satisfaction Questionnaire | The Diabetes Treatment Satisfaction Questionnaire will be used to measure patient perception of the treatment. It is composed of eight questions, each of which is scored by patients on a scale ranging from zero (e.g., very dissatisfied, very inconvenient) to six (e.g., very satisfied, very convenient). More satisfied the patient, better is the outcome. | Baseline, 6 months, 12 months | 
| Change in the Adoption at the clinic level | Adoption at the clinic level will be measured by a number of participants served using health records and examining nurses' adoption of intervention program through interviews | 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuum of care, Diabetes, Pre-diabetes