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NCT Number: NCT05979168

Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal

Despite evidence of preventing cardiovascular disease (CVD) risk through lifestyle changes, many patients with hypertension (HTN) do not comply with this and suffer from CVD and other complications. A previous study using a structured lifestyle intervention program has reported a 14% decrease in the 10-year risk of developing CVD at one year among hypertensive and diabetes patients. Low and Middle-Income countries (LMICs) struggle with a shortage of health workers to deliver such interventions. In this context, mobile phones can contribute to bridging this gap by incorporating them into the health system for health intervention delivery. There is a need to develop contextual mHealth intervention adapted to local needs and culture and test its effectiveness in LMIC settings like Nepal. Our previous small-scale pilot mHealth (text messages) study reported promising evidence in reducing blood pressure among hypertensive patients in the intervention arm [adjusted reduction in systolic blood pressure (BP) -6.50 (95% CI, -12.6; -0.33) and diastolic BP -4.60 (95% CI, -8.16; -1.04)], with a greater proportion achieving target BP (70% vs 48% in the control arm, p = 0.006)] and improving treatment compliance (p < 0.001) in Nepal. This finding supports the expansion to a large-scale trial of a structured mHealth intervention to see its long-term effectiveness and sustainability for patients with HTN to improve BP control and reduce CVD risk. Hence, this study aims to assess the effectiveness of a behavioural intervention through mHealth (telephone/mobile phone calls and text messages) informed by the RE-AIM framework for improving blood pressure control among patients with hypertension in a hospital (Manamohan Cardiothoracic Vascular and Transplant Center) of Kathmandu, Nepal.

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Key information

Conditions

Hypertension Behavior Blood Pressure Cardiovascular Diseases Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahid Gangalal National Heart Center, Kathmandu, Bagmati, Nepal

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About this study

This study will be a hybrid type 2 effectiveness-implementation study using mixed methods, a parallel randomized controlled trial with a nested qualitative design. The intervention will be codesigned involving patients, their family members, and healthcare providers to incorporate their views, the local context and culture through a formative qualitative component informed by the CFIR. A multi-component mHealth intervention will be delivered through text messages and phone calls (TelTex4BP) by nurses, focusing on behaviour changes (physical activity, healthy diet), medication adherence, a reminder for follow-up, smoking, and alcohol intake. The intervention will be delivered for six months, and follow-up will be carried out at the end of the intervention and six months later (at one year) to assess sustainability and long-term effectiveness. Clinical (blood pressure, 10-year risk of CVD), intermediate (medication adherence, change of dietary habits/physical activity), and implementational outcomes ( Reach, Adoption, Intervention fidelity and Maintenance) will be evaluated using the RE-AIM framework. If the intervention is proven effective, the study findings will be disseminated to promote scaling up to other similar settings.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of hypertension
  • Currently receiving/prescribed blood pressure-lowering medication for more than three months
  • With uncontrolled blood pressure (>130/80mm of Hg)
  • Should have access to a mobile phone
  • Able to read text messages ( by themselves/with the help of family)

Exclusion criteria

  • Diagnosed with myocardial infarction, stroke, and kidney failure
  • Severe mental illness, cognitive impairment
  • Pregnant women or in the postpartum period

Treatment and study plan

Phone call and text Messages

Behavioral

The intervention consists of recommended lifestyle counselling (on a healthy diet, physical activity, smoking, alcohol intake, medication adherence and continuity of care). This counselling will be provided through the research nurse at baseline and for six months (tentative plan phone call once a month; frequency and duration will be finalized based on formative study) by calling on participants' given mobile numbers. In addition, text message reminders on the same topics will be delivered regularly (2-3 times a week) for six months. The counselling and message will focus on three domains of COM-B; capabilities needed, opportunities and practical tools, and motivation strategies informed by behaviour change techniques.

Other names: TelTex4BP

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: baseline, 6 and 12 months

    Average of last of two measures of Blood pressure.

Secondary outcomes

  1. Blood Pressure Control

    Time frame: Baseline, 6 and 12 months

    Measures of Systolic and diastolic BP

  2. 10 year risk of development of CVD

    Time frame: Baseline, 6 and 12 months

    Globo CVD risk calculator

  3. Medication adherence

    Time frame: Baseline, 6 and 12 months

    Hill-Bone compliance to high blood pressure therapy scale will be use to measure adherence to antihypertensive therapy. This tool contains 14 items: nine items related to medication, three items on salt intake and two items on appointment keeping. Each item is scored on a response of 1-4. The total score of Hill Bone is 56 where a lower score indicates higher adherence to antihypertensive therapy.

  4. Dietary habits (salt intake, fruits and vegetables intake)

    Time frame: Baseline, 6 and 12 months

    Dietary salt [9 items] based on the WHO STEPs survey

  5. Physical activity

    Time frame: Baseline, 6 and 12 months

    Physical activity [17 items]based on the WHO STEPs survey

Study contacts

Contact information is provided by the study sponsor or research team.

Buna Bhandari, PhD

CONTACT

[email protected]

8508156644

Rabina Dhakal, MPH

CONTACT

[email protected]

977 9841075217

Sponsors and collaborators

Lead sponsor

Central Department of Public Health

Other

Collaborators

  • Apara Innovations Pvt. Ltd
  • Harvard School of Public Health (HSPH)

Registry information

Official study title

Effectiveness and Adoption of the Structured mHealth Intervention for Improving Blood Pressure Control (TelTex4BP) Among Adults With Hypertension in Nepal: A Randomized Controlled Trial

Acronym: TelTex4BP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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