Clinical trial NCT05979168: Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal
Official title: Effectiveness and Adoption of the Structured mHealth Intervention for Improving Blood Pressure Control (TelTex4BP) Among Adults With Hypertension in Nepal: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Medication Adherence
Blood Pressure
Cardiovascular Diseases
Keywords: Mobile Intervention
Blood Pressure Control
Hypertension
Randomized Controlled Trial
Lead sponsor: Central Department of Public Health
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2023-08-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: baseline, 6 and 12 months
Secondary outcomes:
measure: Blood Pressure Control
timeFrame: Baseline, 6 and 12 months
measure: 10 year risk of development of CVD
timeFrame: Baseline, 6 and 12 months
measure: Medication adherence
timeFrame: Baseline, 6 and 12 months
measure: Dietary habits (salt intake, fruits and vegetables intake)
timeFrame: Baseline, 6 and 12 months
measure: Physical activity
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Central Department of Public Health
state: Pradesh 3 (Bagmati)
Study officials:
affiliation: Central Department of Public Health, Tribhuvan University Institue of Medicine Nepal
name: Buna Bhandari Bhattarai, PhD
role: PRINCIPAL_INVESTIGATOR
References: