About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Diagnosed with myocardial infarction, stroke, and kidney failure
Severe mental illness, cognitive impairment
Pregnant women or in the postpartum period
Trial design
Parallel
Treatments tested in this trial
Phone call and text Messages
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Systolic Blood Pressure
Average of last of two measures of Blood pressure.
Secondary outcomes
Blood Pressure Control
Measures of Systolic and diastolic BP
10 year risk of development of CVD
Globo CVD risk calculator
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.
Dietary habits (salt intake, fruits and vegetables intake)
Dietary salt \[9 items\] based on the WHO STEPs survey
Sponsors and contacts
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Central Department of Public Health
Lead sponsor
Indiana University
Sponsor institution
Harvard School of Public Health (HSPH)
Collaborator
Apara Innovations Pvt. Ltd
Collaborator