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NCT05979168
Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal
Conditions: Hypertension, Medication Adherence, Blood Pressure, Cardiovascular Diseases
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 500
Sponsor: Central Department of Public Health
Location: Sahid Gangalal National Heart Center Kathmandu Bagmati
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 Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Diagnosed with myocardial infarction, stroke, and kidney failure
* Severe mental illness, cognitive impairment
* Pregnant women or in the postpartum period
Source: ClinicalTrials.gov (NCT05979168). StuddyBuddy aggregates publicly available trial information.