A Study Protocol to Assess the Effectiveness of Nurse-Led Telehealth Intervention for Hypertension Control in Nepal

NCT07089290 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 706

Last updated 2025-07-28

No results posted yet for this study

Summary

Despite being the leading cause of cardiovascular diseases and premature death worldwide, hypertension control remains a largely unmet challenge for public health systems even in developed countries. Hypertension control in Nepal is challenging due to decreased awareness, limited access to the health facilities caused by geographical constraints and health care personnel shortage. Telehealth can help address these gaps and nurse-led telehealth can be a better option as nurses can provide timely follow up, track patients' progress and offer guidance on medication adherence and lifestyle changes which are crucial for hypertension control.

This study aims to evaluate the effectiveness of nurse-led telehealth for hypertension control among hypertensive adults in Nepal. We will use the Intervention Mapping (IM) approach to develop a theory-based and evidenced nurse-led telehealth intervention for hypertension control. Following IM, a parallel-group 1:1 randomized control trial 353 participants in each group will be used to evaluate the effectiveness of intervention. The intervention consists of regular BP monitoring, video conferencing and virtual drug adjustment. The follow up will be done in 3 and 6 months. Explanatory Sequential mixed Method will be used to assess the acceptability, appropriateness, and feasibility of adapting nurse-led telehealth for hypertension control.

Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analyzed using STATA 14, contributing valuable insights into the potential impact of nurse-led telehealth interventions on increasing hypertension control.

Conditions

  • Hypertension Combined Diastolic and Systolic

Interventions

BEHAVIORAL

Nurse-led Telehealth Intervention

Control group: Patients will receive standard care as per Nepal government guidelines. This includes lifestyle counseling (salt reduction, physical activity, avoiding tobacco/alcohol), antihypertensive medications based on BP and risk profile, and follow-up every 1-3 months. BP will be recorded at 3 and 6 months by research nurses. Intervention group: Nurse-led telehealth care will be delivered over six months using the Intervention Mapping approach. Participants will receive initial orientation, a BP diary, and instructions to check BP at least twice weekly at nearby centers. Nurses will train local staff, and conduct teleconsultations via Viber/WhatsApp every 15 days (months 1-2) and monthly (months 3-6) covering BP review, adherence, and lifestyle advice. If \<75% of BP readings meet target, nurses will consult physicians for medication adjustments. Emergency protocols will be in place. Data will be collected at baseline, 3, and 6 months.

Sponsors & Collaborators

  • Kathmandu University School of Medical Sciences

    lead OTHER

Principal Investigators

  • Archana Shrestha, PhD · Kathmandu University School of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089290 on ClinicalTrials.gov