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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04131257
Recruitment Status : Not yet recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Biraj Man Karmacharya, Kathmandu University School of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Nurse-led Continuum of Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Continuum of care
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
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.

Active Comparator: Usual care
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
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.




Primary Outcome Measures :
  1. Change in Glycated Hemoglobin (HbA1c) level [ Time Frame: Baseline, 6 months, 12 months ]
    The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway)

  2. Change in the incidence of diabetes among individuals with pre-diabetes [ Time Frame: 6 months, 12 months ]
    Electronic Health Record will be used to measure the incidence of diabetes


Secondary Outcome Measures :
  1. Change in Blood Pressure [ Time Frame: Baseline, 6 months, 12 months ]
    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

  2. Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol) [ Time Frame: Baseline, 6 months, 12 months ]
    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)

  3. Change in Body Mass Index [ Time Frame: Baseline, 6 months, 12 months ]
    Body Mass Index will be calculated as weight in kilograms divided by height in meters squared

  4. Change in the "Reach" of people participating in the program [ Time Frame: 6 months, 12 months ]
    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

  5. Change in the "Adoption at the patient level" measured by the Summary of Diabetes Self-Care Activities Scale [ Time Frame: Baseline, 6 months, 12 months ]
    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.

  6. Change in the "Adoption at the patient level" measured by the Diabetes Treatment Satisfaction Questionnaire [ Time Frame: Baseline, 6 months, 12 months ]
    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.

  7. Change in the "Adoption at the clinic level" [ Time Frame: 6 months, 12 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131257


Contacts
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Contact: Biraj M Karmacharya +977 9802000029 birajmk@gmail.com
Contact: Rubee Dev +86 15521049506 meetrubss@hotmail.com

Sponsors and Collaborators
Kathmandu University School of Medical Sciences
Investigators
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Principal Investigator: Biraj M Karmacharya, PhD Kathmandu University School of Medical Sciences

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Responsible Party: Biraj Man Karmacharya, Associate Professor, Kathmandu University School of Medical Sciences
ClinicalTrials.gov Identifier: NCT04131257    
Other Study ID Numbers: KathmanduUSMS
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biraj Man Karmacharya, Kathmandu University School of Medical Sciences:
Continuum of care
Diabetes
Pre-diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia