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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension; Blood Pressure; Medication Adherence
• Intervention / Treatment: Behavioral: Phone call and text Messages

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Buna Bhandari, PhD; Phone Number: 8508156644; Email: buna.bhandari@gmail.com
• Study Contact Backup: Name: Rabina Dhakal, MPH; Phone Number: 977 9841075217; Email: dhakalrabina@gmail.com

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal
      • Recruiting
      • Sahid Gangalal National Heart Center
      • Contact: Rikesh Tamrakar, DM
  • Pradesh 3 (Bagmati)
    • Kathmandu, Pradesh 3 (Bagmati), Nepal, 40660
      • Recruiting
      • Apara Innovations Pvt Ltd
      • Contact: Rabina Dhakal, MPH; Email: dhakalrabina@gmail.com
      • Contact: Dr Buna Bhandari, PhD; Email: buna.bhandari@gmail.com
      • Sub-Investigator: Rikesh Tamrakar
      • Principal Investigator: Buna Bhandari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Hypertensive patients with uncontrolled BP in the intervention group will receive mobile phone text messages in the Nepali language and accept the phone call from the trained research nurse on their given mobile. They will also get the opportunity to ask questions and clarification during the phone call. However, text messaging would be only one way.	Behavioral: Phone call and text Messages; 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
No Intervention: Control arm; The control arm will receive the usual routine maintenance. In Nepal, hypertensive patients usually receive a prescription of antihypertensive medicine and advise for follow-up as the standard care. In addition, a pamphlet containing information about hypertension and required behavior modifications will be provided to all study participants, including the control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Average of last of two measures of Blood pressure.	baseline, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Control	Measures of Systolic and diastolic BP	Baseline, 6 and 12 months
10 year risk of development of CVD	Globo CVD risk calculator	Baseline, 6 and 12 months
Dietary habits (salt intake, fruits and vegetables intake)	Dietary salt [9 items] based on the WHO STEPs survey	Baseline, 6 and 12 months
Physical activity	Physical activity [17 items]based on the WHO STEPs survey	Baseline, 6 and 12 months
Medication adherence	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.	Baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: Central Department of Public Health
• Collaborators: Harvard School of Public Health (HSPH); Apara Innovations Pvt. Ltd
• Investigators: Principal Investigator: Buna Bhandari Bhattarai, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Randomized Controlled Trial; Mobile Intervention; Blood Pressure Control
• Additional Relevant MeSH Terms: Vascular Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Hypertension; Cardiovascular Diseases; Medication Adherence
• Other Study ID Numbers: BLSCHP-2303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No