Group-Care for Hypertension and Diabetes Management in Nepal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
Hypertension and diabetes represent significant and growing public health challenges in Nepal, particularly in underserved communities. Traditional individual-based care approaches may not adequately address the multifaceted needs of patients with these chronic conditions in resource-limited settings. The group care model, which combines peer support, education, and clinical care, offers a promising alternative that could enhance patient outcomes. This protocol outlines a dual cluster randomized controlled trial (DRCT) using a hybrid type II design to evaluate the effectiveness of a group care model for improving the control and management of hypertension and diabetes in four municipalities in Nepal. The trial will also evaluate the implementation outcomes of fidelity and economic costs.
The researchers will assess the effect of the group care model on clinical outcomes. The primary outcomes will be the proportion of patients with controlled versus uncontrolled blood pressure (among patients with hypertension) and the proportion of patients with controlled versus uncontrolled hemoglobin A1c (among patients with diabetes) at 6 and 12 months. The researchers will conduct a three-arm comparison (control vs. low intensity strategies vs. high intensity strategies), with additional pairwise contrasts to examine differences in effectiveness. The researchers will also evaluate intervention fidelity in the two intervention groups and conduct an economic analysis. Each cluster, representing a health facility, will be randomly allocated to one of the three arms after baseline data collection and prior to initiating the intervention phase. The low intensity arm will receive the group care model with standard implementation support, while the high intensity arm will receive the group care model with enhanced implementation strategies. The control arm will continue with the standard of care offered in the nearest health facility, including hypertension and diabetes detection and management based on PEN protocols 1 and 2. After study completion, control facilities will be offered training on the group care model.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and above living in the catchment areas of the 37 health facilities participating in the trial, across the 4 specified municipalities
Individuals who are newly diagnosed with hypertension (defined as systolic blood pressure 140 mmhg or higher and/or diastolic blood pressure 90 mmHg or higher.) and/or diabetes (defined as fasting blood glucose ≥126 mg/dL, random blood glucose ≥200 mg/dL, or Hgb A1c≥6.5).
Individuals with previously known diagnoses of hypertension and/or diabetes with records from health facilities record or patient card of individuals.
Residents of the catchment areas served by the enrolled health facilities in the study sites.
Disqualifiers
Individuals with physical or verbal disabilities that would impede their participation in the intervention activities, such as attending and participating in group discussions, counseling sessions, or self-reporting during data collection.
Pregnant women
People who may migrate within a year
Trial design
Design model
Parallel
Treatments tested in this trial
Low Intensity Community-Based Group NCD Care
BehavioralA community-based group care model for hypertension and diabetes management, facilitated by HWs and FCHVs, delivered with low-intensity implementation strategies, including: * Clinical supervision to FCHVs and HWs at baseline, midline and endline only * Remote quarterly refresher sessions on group care model * Initial governmental meetings * One-time training on data entry forms at initiation of study
High Intensity Community-Based Group NCD Care
BehavioralA community-based group care model for hypertension and diabetes management, facilitated by HWs and FCHVs, delivered with high-intensity implementation strategies including: * Frequent intensive clinical supervision for HWs/FCHVs * Quarterly refresher sessions and monthly remote check-ins about group care * Partnering with municipalities through regular meetings, goal to supplement programming with local governmental funding * Intensive data review (quarterly) with structured feedback and regular quality checks of data entry
Treatment groups
1,110 Participants
are divided into 3 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Low Intensity ImplementationExperimental treatment 1 intervention
Group C: High Intensity ImplementationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with NCD Control from baseline to follow-up
NCD control will be defined as follows: 1. For patients with ONLY hypertension: systolic blood pressure \< 140 mmHg AND diastolic blood pressure \< 90 mm Hg; 2. For patients with only diabetes: HbA1c,% \<7 for diabetes; 3. For patients with hypertension and diabetes: SBP\< 130 and DBP\< 80 AND HbA1c \< 7%
Time frame
at 6 months from start of intervention, and 12 months from start of intervention2
Fidelity Score
Will be determined in high-intensity and low-intensity implementation arms as follows: Fidelity Components Frequency = % of group visits conducted as per protocol. Duration = % attendance at group care session. Coverage of appropriate NCD reading = % of BP and/or blood sugar readings completed as per protocol Coverage of medication = % of visits where medication appropriately received Fidelity Score Calculation Fidelity Scoring: Each component receives a standardized score from 0 to 100 where 0 = non-adherence and 100 = full adherence. The overall fidelity score will be calculated per patient using this formula: Fidelity Score = Σ (W × C) / 4, where W = 25% (equal weight per component) and C = score for each component.
Time frame
at 6 months and at 12 months from start of interventionSecondary outcomes
1
Change in Systolic BP (mmHg) and Diastolic BP
Net change in mean systolic BP from baseline to follow up, net change in mean diastolic BP from baseline to follow up
Time frame
at baseline, 6 months and 12 months2
Hb A1c (percentage)
Blood test to measure percentage of glycated hemoglobin for patients with diabetes
Time frame
at baseline, 6 months and 12 months3
Hypertension Knowledge Level Scale (HK-LS)
HK-LS: Hypertension Knowledge Level Scale is a validated 22-point survey on hypertension knowledge. Full scale scored from 0-22. Higher scores mean better knowledge.
Time frame
at baseline and 12 months4
Diabetes Knowledge Questionnaire (DKQ)
DKQ- Diabetes Knowledge Questionnaire is a validated 24-point questionnaire on basic diabetes knowledge. Full scale scored from 0-24 with higher score implying better knowledge of diabetes.
Time frame
at baseline and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
Kathmandu University School of Medical Sciences
Collaborator
Source ClinicalTrials.gov
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