Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal (NUCOD)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nurse-led Continuum of Care
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Continuum of care, Diabetes, Pre-diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Continuum of care
Usual care
Arm Description
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.
The control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group.
Outcomes
Primary Outcome Measures
Change in Glycated Hemoglobin (HbA1c) level
The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway)
Change in the incidence of diabetes among individuals with pre-diabetes
Electronic Health Record will be used to measure the incidence of diabetes
Secondary Outcome Measures
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
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)
Change in Body Mass Index
Body Mass Index will be calculated as weight in kilograms divided by height in meters squared
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
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.
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.
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
Full Information
NCT ID
NCT04131257
First Posted
October 15, 2019
Last Updated
October 16, 2019
Sponsor
Kathmandu University School of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04131257
Brief Title
Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kathmandu University School of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Continuum of care, Diabetes, Pre-diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1236 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuum of care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led Continuum of Care
Intervention Description
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 Measure Information:
Title
Change in Glycated Hemoglobin (HbA1c) level
Description
The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway)
Time Frame
Baseline, 6 months, 12 months
Title
Change in the incidence of diabetes among individuals with pre-diabetes
Description
Electronic Health Record will be used to measure the incidence of diabetes
Time Frame
6 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Blood Pressure
Description
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
Time Frame
Baseline, 6 months, 12 months
Title
Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol)
Description
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)
Time Frame
Baseline, 6 months, 12 months
Title
Change in Body Mass Index
Description
Body Mass Index will be calculated as weight in kilograms divided by height in meters squared
Time Frame
Baseline, 6 months, 12 months
Title
Change in the "Reach" of people participating in the program
Description
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
Time Frame
6 months, 12 months
Title
Change in the "Adoption at the patient level" measured by the Summary of Diabetes Self-Care Activities Scale
Description
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.
Time Frame
Baseline, 6 months, 12 months
Title
Change in the "Adoption at the patient level" measured by the Diabetes Treatment Satisfaction Questionnaire
Description
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.
Time Frame
Baseline, 6 months, 12 months
Title
Change in the "Adoption at the clinic level"
Description
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
Time Frame
6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biraj M Karmacharya
Phone
+977 9802000029
Email
birajmk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rubee Dev
Phone
+86 15521049506
Email
meetrubss@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biraj M Karmacharya, PhD
Organizational Affiliation
Kathmandu University School of Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
32471476
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.
Results Reference
derived
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Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal
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