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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Nepal
Apara Innovations Pvt Ltd
RECRUITING
Kathmandu
Sahid Gangalal National Heart Center
RECRUITING
Kathmandu
Contact Information
Primary
Buna Bhandari
buna.bhandari@gmail.com
9851320990
Backup
Rabina Dhakal, MPH
dhakalrabina@gmail.com
Time Frame
Start Date: 2025-11-02
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 500
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Harvard School of Public Health (HSPH), Apara Innovations Pvt. Ltd
Leads: Central Department of Public Health

This content was sourced from clinicaltrials.gov