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

Primary Purpose

Hypertension, Medication Adherence, Blood Pressure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Phone call and text Messages
Sponsored by
Central Department of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Mobile Intervention, Blood Pressure Control, Hypertension, Randomized Controlled Trial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central Department of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure
Average of last of two measures of Blood pressure.

Secondary Outcome Measures

Blood Pressure Control
Measures of Systolic and diastolic BP
10 year risk of development of CVD
Globo CVD risk calculator
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.
Dietary habits (salt intake, fruits and vegetables intake)
Dietary salt [9 items] based on the WHO STEPs survey
Physical activity
Physical activity [17 items]based on the WHO STEPs survey

Full Information

First Posted
July 30, 2023
Last Updated
August 7, 2023
Sponsor
Central Department of Public Health
Collaborators
Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT05979168
Brief Title
Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Department of Public Health
Collaborators
Harvard School of Public Health (HSPH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Medication Adherence, Blood Pressure, Cardiovascular Diseases
Keywords
Mobile Intervention, Blood Pressure Control, Hypertension, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Phone call and text Messages
Other Intervention Name(s)
TelTex4BP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Average of last of two measures of Blood pressure.
Time Frame
baseline, 6 and 12 months
Secondary Outcome Measure Information:
Title
Blood Pressure Control
Description
Measures of Systolic and diastolic BP
Time Frame
Baseline, 6 and 12 months
Title
10 year risk of development of CVD
Description
Globo CVD risk calculator
Time Frame
Baseline, 6 and 12 months
Title
Medication adherence
Description
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.
Time Frame
Baseline, 6 and 12 months
Title
Dietary habits (salt intake, fruits and vegetables intake)
Description
Dietary salt [9 items] based on the WHO STEPs survey
Time Frame
Baseline, 6 and 12 months
Title
Physical activity
Description
Physical activity [17 items]based on the WHO STEPs survey
Time Frame
Baseline, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Buna Bhandari
Phone
9851320990
Email
buna.bhandari@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pranil Man Singh Pradhan
Email
pranil.pradhan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buna Bhandari Bhattarai, PhD
Organizational Affiliation
Central Department of Public Health, Tribhuvan University Institue of Medicine Nepal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Department of Public Health
City
Kathmandu
State/Province
Pradesh 3 (Bagmati)
ZIP/Postal Code
40660
Country
Nepal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Buna Bhandari, PhD
Phone
9851320990
Email
buna.bhandari@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr Pranil Man Singh Pradhan, MD
Email
pranil.pradhan@gmail.com
First Name & Middle Initial & Last Name & Degree
Buna Bhandari Bhattarai
First Name & Middle Initial & Last Name & Degree
Pranil Man Singh Pradhan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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