HypertensionTelTex4BPNCT05979168
Effectiveness and Adoption of the TelTex4BP Intervention Among Adults With Hypertension in Nepal
A study testing Phone call and text Messages in people with Hypertension and Medication Adherence, run by Central Department of Public Health at 2 sites in Nepal.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Medication Adherence, Blood Pressure
- What is being tested?
- Phone call and text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesNepal
- Study dates
- 2 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertension
- Currently receiving/prescribed blood pressure-lowering medication for more than three months
- With uncontrolled blood pressure (>130/80mm of Hg)
- Should have access to a mobile phone
- Able to read text messages ( by themselves/with the help of family)
Who cannot join
- Diagnosed with myocardial infarction, stroke, and kidney failure
- Severe mental illness, cognitive impairment
- Pregnant women or in the postpartum period
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal2 sites, 2 recruiting
- Recruiting
Sahid Gangalal National Heart Center
Kathmandu, Bagmati
Rikesh Tamrakar, DM
- Recruiting
Apara Innovations Pvt Ltd
Kathmandu, Pradesh 3 (Bagmati), 40660
Dr Buna Bhandari, PhD, buna.bhandari@gmail.com
Rabina Dhakal, MPH, dhakalrabina@gmail.com
About this study
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
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.
Read the 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 CFIR. 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.
- Being tested
- Phone call and text Messages
- Keywords
- Mobile Intervention, Blood Pressure Control, Hypertension, Randomized Controlled Trial
- Medical subject headings
- Hypertension, Medication Adherence, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone call and text MessagesBehavioural
Also called TelTex4BP
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Behavioral: Phone call and text Messages |
| Control arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Average of last of two measures of Blood pressure.
Measured: baseline, 6 and 12 months
Secondary outcomes (5)
Blood Pressure Control
Measures of Systolic and diastolic BP
Measured: Baseline, 6 and 12 months
10 year risk of development of CVD
Globo CVD risk calculator
Measured: Baseline, 6 and 12 months
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.
Measured: Baseline, 6 and 12 months
Dietary habits (salt intake, fruits and vegetables intake)
Dietary salt [9 items] based on the WHO STEPs survey
Measured: Baseline, 6 and 12 months
Physical activity
Physical activity [17 items]based on the WHO STEPs survey
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start2 Nov 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Department of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Apara Innovations Pvt. Ltd
- Responsible party
- Principal investigator, Buna Bhandari, Indiana University
- Investigators
- Buna Bhandari Bhattarai, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979168
- Sponsor's protocol ID
- BLSCHP-2303
- Acronym
- TelTex4BP
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05979168
- Acronym / sponsor ID
- TelTex4BP / BLSCHP-2303
- Keywords
- Mobile Intervention, Blood Pressure Control, Hypertension, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Department of Public HealthUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Apara Innovations Pvt. Ltd
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 CFIR. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Phone call and text MessagesHypertensive 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. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of hypertension
- Currently receiving/prescribed blood pressure-lowering medication for more than three months
- With uncontrolled blood pressure (>130/80mm of Hg)
- Should have access to a mobile phone
- Able to read text messages ( by themselves/with the help of family)
Key exclusion criteria (3 listed)
- Diagnosed with myocardial infarction, stroke, and kidney failure
- Severe mental illness, cognitive impairment
- Pregnant women or in the postpartum period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone call and text MessagesAlso: TelTex4BPThe 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. | Behavioural | Intervention arm |
Primary outcome
Systolic Blood Pressure
Time frame: baseline, 6 and 12 months
Average of last of two measures of Blood pressure.
5 secondary outcomes
Blood Pressure Control
Time frame: Baseline, 6 and 12 months
10 year risk of development of CVD
Time frame: Baseline, 6 and 12 months
Medication adherence
Time frame: Baseline, 6 and 12 months
Dietary habits (salt intake, fruits and vegetables intake)
Time frame: Baseline, 6 and 12 months
Physical activity
Time frame: Baseline, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Buna Bhandari Bhattarai, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call and text Messages in people with Hypertension and Medication Adherence, run by Central Department of Public Health at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Buna Bhandari, PhD (8508156644, buna.bhandari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.