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

NCT05979168 | Recruiting DMC

• 1 other identifier: BLSCHP-2303
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypertension; Medication Adherence; Blood Pressure; Cardiovascular Diseases

Keywords

Mobile Intervention; Blood Pressure Control; Hypertension; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Average of last of two measures of Blood pressure.

  baseline, 6 and 12 months

Secondary Outcomes (5)

• Blood Pressure Control

  Baseline, 6 and 12 months

• 10 year risk of development of CVD

  Baseline, 6 and 12 months

• Medication adherence

  Baseline, 6 and 12 months

• Dietary habits (salt intake, fruits and vegetables intake)

  Baseline, 6 and 12 months

• Physical activity

  Baseline, 6 and 12 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

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.

Also known as: TelTex4BP

Intervention arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of hypertension
• Currently receiving/prescribed blood pressure-lowering medication for more than three month
• With uncontrolled blood pressure (\>140/90mm of Hg)
• Should have access to a mobile phone
• Able to read text messages ( by themselves/with the help of family)

You may not qualify if:

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

Sponsors & Collaborators

• Central Department of Public Health: lead
• Harvard School of Public Health (HSPH): collaborator
• Apara Innovations Pvt. Ltd: collaborator

Study Sites (2)

Sahid Gangalal National Heart Center

Kathmandu, Bagmati, Nepal

RECRUITING

Apara Innovations Pvt Ltd

Kathmandu, Pradesh 3 (Bagmati), 40660, Nepal

RECRUITING

MeSH Terms

Conditions

Hypertension; Medication Adherence; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Buna Bhandari Bhattarai, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Buna Bhandari

CONTACT

9851320990; buna.bhandari@gmail.com

Rabina Dhakal, MPH

CONTACT

dhakalrabina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will use a two-arm parallel-group, individually randomized control trial design to test the effectiveness of a TelTex4BP intervention compared to standard care at one year among diagnosed patients of HTN.

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: November 2, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (2)