An interventional study of Low Intensity Community-Based Group NCD Care and High Intensity Community-Based Group NCD Care in Hypertension and Diabetes, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in Nepal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
This dual randomized controlled trial will be conducted across 37 health facilities in four municipalities in Nepal- Panchkhal, Bhumlu, Tamakoshi, and Bhimeshwor. The health facilities will be randomly assigned to three arms: control (n =12-13), low intensity implementation (n = 12-13 ), and high intensity implementation (n =12-13). Each intervention cluster will form 2-3 group care groups, each comprising of 8-10 participants, with group sessions facilitated by health workers and Female Community Health Volunteers (FCHVs). The low-intensity arm will receive the group care model with standard implementation support, while the high-intensity strategy arm will receive the group care model with enhanced implementation strategies. Group sessions will be conducted every month, focusing on lifestyle modification, medication adherence, and peer support. The patients in the control arm will continue to receive usual care at the nearest health facility, including hypertension and diabetes detection and management based on the WHO PEN Protocols. After study completion, control facilities will be offered training on the group care model. Data will be collected at baseline, 6 months, and 12 months. The primary effectiveness outcomes will be the proportion of patients with controlled versus systolic blood pressure (among patients with hypertension) and HbA1c (among patients with diabetes), assessed at 6 and 12 months. The primary implementation outcome will be intervention fidelity between the intervention arms, using a fidelity scoring system comparing the high intensity and low intensity intervention groups. The researchers will conduct a three-arm comparison (control vs. low intensity vs. high intensity implementation), with additional pairwise contrasts to examine differences in effectiveness. The researchers will also conduct an economic analysis, looking at program costs and comparing costs between the two intervention arms. This study will seek to determine the effectiveness of the group care model at both high intensity and low intensity doses in managing hypertension and diabetes within the context of Nepal. The researchers anticipate that the intervention will lead to significant improvements in blood pressure and blood glucose control, and improvements in hypertension and diabetes knowledge and medication adherence. Additionally, the trial will explore the scalability of the group care model in other resource-constrained settings. The findings from this study will provide valuable insights into the potential for group care models to address the growing burden of non-communicable diseases in Nepal and similar contexts.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 1,110 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
390 participants, at the 13 health facilities selected for the control arm, with hypertension will be linked to usual care.
360 participants, affiliated with the 12 health facilities, with hypertension and diabetes will be assigned to receive group care with low intensity implementation strategies.
Behavioral: Low Intensity Community-Based Group NCD Care
360 patients, affiliated with the 12 health facilities, with hypertension and diabetes patients will be assigned to receive group care, that will be delivered with high intensity implementation strategies.
Behavioral: High Intensity Community-Based Group NCD Care
A 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
A 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
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 intervention
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 intervention
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 months
Hb A1c (percentage)
Blood test to measure percentage of glycated hemoglobin for patients with diabetes
Time frame: at baseline, 6 months and 12 months
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 months
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 months
Hill-Bone Blood Pressure Scale
Hill-Bone Blood Pressure scale- 14-item scale to assess patient behaviors for three domains of BP treatment including sodium intake, appointment keeping, and medication keeping. Each item is a four point Likert-type scale, Full scale scored from 4 to 56 and higher scores mean better adherence. This set of questions will only be asked to patients with hypertension.
Time frame: at baseline and 12 months
Self Efficacy for Managing Chronic Disease
Self Efficacy for Managing Chronic Disease - 6 question validated scale asking about confidence in different parts of chronic disease management, Full scale scored from 6 to 60, higher score indicates higher confidence in managing chronic disease
Time frame: at baseline and 12 months
Smoking amount
Smoking: Asking if participant smokes and what products they use, and how many times they smoke per day/week.
Time frame: at baseline and 12 months
Alcohol amount
Alcohol: Asking if participant drinks alcohol and what types of drinks they have, how many times they drink per day/week.
Time frame: at baseline and 12 months
Metabolic equivalents (MET) minutes per week.
Physical Activity: Measuring number of metabolic equivalents (MET) minutes per week using the global physical activity questionnaire (GPAQ) The global physical activity questionnaire (GPAQ) is a 16 item instrument. Each object has a specific code starting from P1 to P16, which is then used to calculate activity in MET value. Scores are split across work, recreation and transport domains.
Time frame: at baseline and 12 months
Total program delivery costs
Total program delivery costs required for implementing the group care model (personnel, training, materials, supervision, logistics).
Time frame: 12 months
Costs of strategies
Comparison of costs across the three intervention arms (control, low intensity strategy, high intensity strategy).
Time frame: 12 months
Cost per participant
Cost per participant enrolled and cost per participant achieving BP or HbA1c control.
Time frame: 12 months
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 13 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 13 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
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