Background
Methods
Design
Setting
Participants
Eligibility criteria for health centers/health posts
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Outreach centers/health posts located in the Kavrepalanchowk and Sindhupalchowk districts
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Have a nurse (staff nurse or auxiliary nurse midwife (ANM))
Eligibility criteria for participants
Screening and recruitment
Randomization
Baseline assessment
Intervention: NUCOD program components
- ▪ Training of nurses: by drawing from standard training manuals published by the International Diabetes Federation and American Diabetes Association, the project management team will first develop a protocol and content for the training of nurses for this program. This training protocol will be tailored to the context of Nepal and will include case studies and examples relevant to Nepal. The training will focus on clinical as well as case management skills. We will train 26 nurses (one for each site) into diabetes nurses using this training protocol.
- ▪ Community awareness campaigns: the nurses will lead the organization of a mass campaign on diabetes in coordination with local newspapers, radio stations, youth groups, municipality offices, district health offices and other health facilities. The campaigns will, in particular, include a simple diabetes risk factor assessment tool to be adapted from the Type 2 Diabetes Risk Test (DRT) of the American Diabetes Association [18]. The campaign will encourage people with high risk to attend the screening program.
- ▪ Screening programs: the nurses will organize screening programs for both diabetes and prediabetes for the community members on specific dates and sites, which will be communicated beforehand to the people in the locality. The screening will be done in coordination with the clinical biochemistry department of DH.
- ▪ Linkage to clinical care: people who screened positive for diabetes and prediabetes (pre-existing as well as new) will be linked to the DH clinic by nurses, where they will be recruited into the program and will receive their group assignment. People assigned to the control group will follow the usual procedure, while those assigned to the intervention group will attend a 1-h nurse-led counseling session on diabetic care. The patients will be responsible for their medical costs (laboratory investigations and medicine), while people experiencing financial hardship can apply for charity care (free or at a reduced price) with guidance from the nurse. The assigned nurse will be responsible for determining their financial profile by reviewing the annual household income, applicable assets, available insurance coverage and confirmation of other sources of payment.
- ▪ Community follow-up counseling and support for the diabetic patients: the nurse will organize diabetic patients into groups of 10 and arrange bimonthly meetings (each 2 h in length) in which the patients will be facilitated using the 5A framework (Assess, Advise, Agree, Assist and Arrange follow-up) to adopt a healthy lifestyle (dietary changes, physical activity, cessation of smoking, etc.) [19]. In addition to the lifestyle changes, the participants will also be facilitated to adhere to medical advice (timely follow-up, adherence to medications, etc.). The nurses will also coordinate with the diabetes clinic at the hospital to ensure that the clinical care and the community-level interventions complement each other. They will also have an electronic tablet that has all the details (laboratory results, behavioral parameters, anthropometric measures, etc.) of the participants so that the progress of the participants in these parameters can be recorded and assessed.
- ▪ Prevention programs for prediabetic participants: in addition to the people with diabetes, the nurses will also form groups of prediabetes participants and will arrange monthly meetings to help facilitate the adoption of a healthy lifestyle using the Diabetes Prevention Program (DPP) curriculum. The DPP lifestyle intervention has been associated with significantly reducing the development of diabetes through its structured behavior-changing approaches [20]. A multidisciplinary team of dieticians and physical therapists will assist with the other components of the DPP program that are related to nutrition and physical activity.
Intervention group | Control group | |
---|---|---|
Community awareness campaigns led by trained nurses | x | x |
Screening | x | x |
Linkage to clinical care | x | |
• Coordinated through the nurses | x | |
• provided by FCHVs without involvement of the nurse | x | |
Improved quality of care at the hospital | x | x |
Nurse-led counseling | x | |
Community follow-up coordinated through the nurses | x | |
Prevention program to prediabetics through the nurses | x |
Outcome measures
Assessment method | Assessor | Baseline | Midline (6 months) | End line (12 months) | Variable | |
---|---|---|---|---|---|---|
Clinical outcomes | ||||||
Primary outcome | ||||||
Glycemic control (HbA1c)a for diabetes | Blood sample | Biochemist | x | x | x | Continuous |
Incidence of diabetes among prediabetes | EHR | RA/nurse | x | x | Binary | |
Secondary outcomes | ||||||
Blood pressure | Electronic monitor | RA/nurse | x | X | x | Continuous |
Lipid profile | Blood sample | Biochemist | x | X | x | Continuous |
Body mass index | EHRb | RA/nurse | x | x | x | Continuous |
Implementation outcomes | ||||||
Reach | Log recordc | RA/nurse | x | x | Continuous | |
Adoption | SDSCA/DTSQ | RA/nurse | x | x | x | Binary |
Implementation (fidelity) | Checklist | SP | x | x | Continuous | |
Self-monitoring of glucose | Self-reported | RA/nurse | x | x | Binary | |
Medication adherence | Self-reported | RA/nurse | x | x | Binary |
Clinical outcomes
Implementation outcomes
- 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.
- Effectiveness will be represented by the clinical outcomes.
- Adoption at the patient level will be measured by the proportion of people adherent to the clinical advice in lifestyle and self-care—this will be measured by the self-reported Summary of Diabetes Self-Care Activities (SDSCA) scale [32] at baseline, 6 months and 12 months (the SDSCA measure is a brief self-report questionnaire that includes items assessing general diet, specific diet, exercise, blood-glucose testing, foot care and smoking) and, in addition, the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [33] will be administered at baseline, 6 months and 12 months (the DTSQ is the most commonly used patient-reported outcome in diabetes trials, which reflects the patient’s perception of the treatment)—and at the clinic level will be measured by the proportion of health clinics successfully recruited into the program over the clinics eligible and approached to participate in the program.
- Implementation will examine the fidelity and quality of the program execution per protocol. To check program fidelity, we will select and train standardized patients (SPs) from the program participants with stable conditions—these SPs will serve as the “secret agents” and the sentry to assess program fidelity with a quality checklist through their routine encounters with the clinicians at the DH diabetes clinic and the nurses; the clinicians will be blinded to the status of the SPs; and the development of SPs and the checklist will follow the protocol we have developed in a separate study [34].
- Maintenance will not be assessed for the purpose of this study.