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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorKathmandu University School of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 30 years and above

Blood pressure at baseline of more than 140 or 90 mm Hg on at least two separate visits or under antihypertensive medications

Willing to monitor their blood pressure and self-titrate medication

Possess a smartphone with internet access and WhatsApp/Viber at least biweekly

Disqualifiers

Pregnant women

Patients in hypertensive crisis (BP ≥180/120 mm Hg)

Had a stroke in the past 30 days or are on dialysis

Individuals with self-reported serious advanced illness such as terminal cancer

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nurse-led Telehealth Intervention

    Behavioral

    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.

Treatment groups

706 Participants
are divided into 2 treatment groups
Group A: Standard CareActive comparator 1 intervention
Group B: Nurse-led Telehalth InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Systolic Blood Pressure

It is the difference in Systolic Blood Pressure from the endline to baseline measured in mmHg.

Time frame
6 months

Secondary outcomes

1

Change in Diastolic Blood pressure

It is the difference in Systolic Blood Pressure from the endline to baseline measured in mmHg.

Time frame
6 months
2

Blood pressure control

It is the difference in blood pressure control from the endline to baseline measured in percentage.

Time frame
6 months
3

Medication Adherence

it is the difference in Medication Adherence measured using Hill-Bone Compliance to High Blood Pressure Therapy Scale (HBCTS) from endline to baseline.

Time frame
6 months
4

Hypertension selfcare

It is the difference in the Hypertension selfcare measured by using Hypertension Selfcare profile from endline to baseline.

Time frame
6 months

Other outcomes

Sponsors and contacts

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