Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal

Hypertension Clinical Trial

— TelTex4BP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05979168
• Other study ID #: BLSCHP-2303
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: Central Department of Public Health
• Contact: Buna Bhandari
• Phone: 9851320990
• Email: buna.bhandari[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Hypertension
• Medication Adherence

Intervention

Behavioral:
• Phone call and text Messages
The 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.

Locations

Country	Name	City	State
Nepal	Central Department of Public Health	Kathmandu	Pradesh 3 (Bagmati)

Sponsors (2)

Lead Sponsor	Collaborator
Central Department of Public Health	Harvard School of Public Health (HSPH)

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Average of last of two measures of Blood pressure.	baseline, 6 and 12 months
Secondary	Blood Pressure Control	Measures of Systolic and diastolic BP	Baseline, 6 and 12 months
Secondary	10 year risk of development of CVD	Globo CVD risk calculator	Baseline, 6 and 12 months
Secondary	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.	Baseline, 6 and 12 months
Secondary	Dietary habits (salt intake, fruits and vegetables intake)	Dietary salt [9 items] based on the WHO STEPs survey	Baseline, 6 and 12 months
Secondary	Physical activity	Physical activity [17 items]based on the WHO STEPs survey	Baseline, 6 and 12 months