Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal
- Conditions
- Medication AdherenceBlood PressureCardiovascular DiseasesHypertension
- Interventions
- Behavioral: Phone call and text Messages
- Registration Number
- NCT05979168
- Lead Sponsor
- Central Department of Public Health
- 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.
- 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 COM-B model. 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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)
- Diagnosed with myocardial infarction, stroke, and kidney failure
- Severe mental illness, cognitive impairment
- Pregnant women or in the postpartum period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Phone call and text Messages 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.
- Primary Outcome Measures
Name Time Method Systolic Blood Pressure baseline, 6 and 12 months Average of last of two measures of Blood pressure.
- Secondary Outcome Measures
Name Time Method Blood Pressure Control Baseline, 6 and 12 months Measures of Systolic and diastolic BP
Medication adherence Baseline, 6 and 12 months 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.
10 year risk of development of CVD Baseline, 6 and 12 months Globo CVD risk calculator
Dietary habits (salt intake, fruits and vegetables intake) Baseline, 6 and 12 months Dietary salt \[9 items\] based on the WHO STEPs survey
Physical activity Baseline, 6 and 12 months Physical activity \[17 items\]based on the WHO STEPs survey
Trial Locations
- Locations (1)
Central Department of Public Health
🇳🇵Kathmandu, Pradesh 3 (Bagmati), Nepal