Diabetes Mellitus, Type 2NUCODNCT04131257
Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal
A study testing Nurse-led Continuum of Care in people with Diabetes Mellitus, Type 2, run by Kathmandu University School of Medical Sciences.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Nurse-led Continuum of Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,236 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- are not psychologically capable of communication
- are diagnosed as type 1 diabetes
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Nurse-led Continuum of Care
- Keywords
- Continuum of care, Diabetes, Pre-diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Continuum of CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Nurse-led Continuum of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c) level
The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway)
Measured: 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
Measured: 6 months, 12 months
Secondary outcomes (7)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biraj Man Karmacharya, Kathmandu University School of Medical Sciences
- Investigators
- Biraj M Karmacharya, PhD, Principal investigator, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131257
- Sponsor's protocol ID
- KathmanduUSMS
- Acronym
- NUCOD
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome will be made available.
Publications
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.
PubMed 32471476
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04131257
- Acronym / sponsor ID
- NUCOD / KathmanduUSMS
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Continuum of care, Diabetes, Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,236 participants (estimated)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuum of care | Experimental | Behavioral: Nurse-led Continuum of CareTrained 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. |
| Usual care | Active comparator | Behavioral: Nurse-led Continuum of CareThe control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- are not psychologically capable of communication
- are diagnosed as type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led Continuum of CareThis 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. | Behavioural | Continuum of care, Usual care |
Primary outcome
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)
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
7 secondary outcomes
Change in Blood Pressure
Time frame: Baseline, 6 months, 12 months
Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol)
Time frame: Baseline, 6 months, 12 months
Change in Body Mass Index
Time frame: Baseline, 6 months, 12 months
Change in the "Reach" of people participating in the program
Time frame: 6 months, 12 months
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
Change in the "Adoption at the patient level" measured by the Diabetes Treatment Satisfaction Questionnaire
Time frame: Baseline, 6 months, 12 months
Change in the "Adoption at the clinic level"
Time frame: 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Derived from this study: PubMed 32471476Xu 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biraj M Karmacharya, PhD principal investigator
Kathmandu University School of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Continuum of Care in people with Diabetes Mellitus, Type 2, run by Kathmandu University School of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biraj M Karmacharya (+977 9802000029, birajmk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) level (time frame: Baseline, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.