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

Diabetes Mellitus, Type 2 Clinical Trial

— NUCOD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04131257
• Other study ID #: KathmanduUSMS
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: Kathmandu University School of Medical Sciences
• Contact: Biraj M Karmacharya
• Phone: +977 9802000029
• Email: birajmk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1236
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Prediabetic State

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kathmandu University School of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Hemoglobin (HbA1c) level	The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway)	Baseline, 6 months, 12 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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