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

NCT04131257 | Unknown DMC

• 1 other identifier: KathmanduUSMS
• Study Type: interventional
• Target: 1,236
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Continuum of care; Diabetes; Pre-diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Blood Pressure

  Baseline, 6 months, 12 months

• Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol)

  Baseline, 6 months, 12 months

• Change in Body Mass Index

  Baseline, 6 months, 12 months

• Change in the "Reach" of people participating in the program

  6 months, 12 months

• Change in the "Adoption at the patient level" measured by the Summary of Diabetes Self-Care Activities Scale

  Baseline, 6 months, 12 months

Study Arms (2)

Continuum of care

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Nurse-led Continuum of Care BEHAVIORAL

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.

Continuum of care; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• are not psychologically capable of communication
• are diagnosed as type 1 diabetes

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Related Publications (1)

• 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.

  PMID: 32471476 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Biraj M Karmacharya, PhD

  Kathmandu University School of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biraj M Karmacharya

CONTACT

+977 9802000029; birajmk@gmail.com

Rubee Dev

CONTACT

+86 15521049506; meetrubss@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.