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

NCT ID: NCT05979168

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2025-08-31

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.

Conditions

Hypertension; Medication Adherence; Blood Pressure; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention arm

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.

Group Type: EXPERIMENTAL

Phone call and text Messages

Intervention Type: BEHAVIORAL

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.

Control arm

The control arm will receive the usual routine maintenance. In Nepal, hypertensive patients usually receive a prescription of antihypertensive medicine and advise for follow-up as the standard care. In addition, a pamphlet containing information about hypertension and required behavior modifications will be provided to all study participants, including the control arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TelTex4BP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Central Department of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Buna Bhandari Bhattarai, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Department of Public Health, Tribhuvan University Institue of Medicine Nepal

Locations

Central Department of Public Health

Kathmandu, Pradesh 3 (Bagmati), Nepal

Countries

Nepal

Central Contacts

Buna Bhandari

Role: CONTACT

buna.bhandari@gmail.com

9851320990

Pranil Man Singh Pradhan

Role: CONTACT

pranil.pradhan@gmail.com

Facility Contacts

Dr Buna Bhandari, PhD

Role: primary

buna.bhandari@gmail.com

9851320990

Dr Pranil Man Singh Pradhan, MD

Role: backup

pranil.pradhan@gmail.com

Other Identifiers

BLSCHP-2303

Identifier Type: -

Identifier Source: org_study_id