HypertensionNCT07878728
Text Message Support to Help Adults With Newly Diagnosed High Blood Pressure Control Their Blood Pressure in Primary Care Clinics in Germany and Pakistan
A study testing mHealth Text Message Program in people with Hypertension and Primary Hypertension, run by GIFT University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if text messages can help adults with newly diagnosed high blood pressure (hypertension) bring their blood pressure under control. The study took place in primary care clinics in Bangladesh and Pakistan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Primary Hypertension
- What is being tested?
- mHealth Text Message Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,295 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Apr 2025to 11 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosed with primary hypertension within the past 4 weeks
- Receiving care at one of the participating primary care clinics
Who cannot join
- Secondary hypertension
- Recent major cardiovascular event (stroke or heart attack)
- Enrolled in another blood pressure management study or another interventional study
- Serious health conditions that could interfere with participation or with measuring outcomes
- Unable to understand study procedures
- Unable to communicate with researchers by mobile phone
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gujranwala Institute of Future Technologies
Multan Khurd, Punjab, Pakistance, 60000
About this study
Official title: Effectiveness of a Mobile Health-Supported Hypertension Management Program on Blood Pressure Control in Primary Care: A Cluster Randomized Clinical Trial
The goal of this clinical trial is to learn if text messages can help adults with newly diagnosed high blood pressure (hypertension) bring their blood pressure under control. The study took place in primary care clinics in Bangladesh and Pakistan. The main questions it aims to answer are:
Do more participants who get text messages have their blood pressure under control after 6 months? Under control means a top number below 140 and a bottom number below 90.
Read more
Do text messages help participants take their blood pressure medicine as prescribed?
Researchers compared a text message program to usual care to see if the text messages work to lower blood pressure. They randomly assigned whole clinics, not individual people, to one of the two groups.
Participants:
Got text messages for 6 months, or got written health materials and usual care. Received daily messages for the first month and fewer after that, if in the text message group. The messages encouraged taking medicine, healthy habits, and checking blood pressure.
Had their blood pressure checked at 9 weeks and at 6 months.
Read the detailed description
Hypertension is a major risk factor for heart disease and death worldwide, and it can be treated. But many people with hypertension still do not reach healthy blood pressure levels. This trial tests whether a low-cost text message program can help adults with newly diagnosed hypertension reach blood pressure control in routine primary care.
The trial is multicenter and cluster randomized. Researchers randomly assigned whole primary care clinics, rather than individual participants, to the text message program or usual care. Clinics were assigned in a 2:1 ratio, so twice as many clinics offered the text message program as usual care. Participants were followed for 6 months.
Blood pressure control was the main focus because it is the clinical goal of hypertension treatment. The trial also looked at several other measures of how participants did on treatment. These include blood pressure control at an earlier point (9 weeks), how long participants stayed on their medicine, whether treatment worked or failed, how many participants dropped out of follow-up, and deaths.
Because participants in the same clinic may have similar outcomes, the analysis accounts for clustering by clinic.
- Conditions
- Hypertension, Primary Hypertension
- Being tested
- mHealth Text Message Program, Usual Care
- Keywords
- mHealth, Mobile health, Text messaging (SMS), Blood pressure control Medication adherence, Lifestyle modification, Primary care, Cluster randomized trial, Low- and middle-income countries, Digital health
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Text Message ProgramBehavioural
Participants receive text messages on their mobile phones for 6 months. The messages encourage three things: taking blood pressure medicine as prescribed, making healthy lifestyle changes, and checking blood pressure. Messages are sent daily for the first month and less often after that. Participants receive this program in addition to routine hypertension care at their clinic.
Usual CareOther
Participants receive written educational materials about hypertension and routine hypertension care at their clinic for 6 months. They do not receive text messages.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Text Message Program | Experimental | Participants receive text messages for 6 months that encourage taking blood pressure medicine, making healthy lifestyle changes, and checking blood pressure. Messages are sent daily for the first month and less often after that. Participants also receive routine hypertension care at their clinic. Receives: Behavioral: mHealth Text Message Program |
| Usual Care | Active comparator | Participants receive written educational materials about hypertension and routine hypertension care at their clinic for 6 months. They do not receive text messages. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control at 6 months
Percentage of participants whose blood pressure is under control at 6 months. Control means systolic blood pressure (the top number) below 140 mm Hg and diastolic blood pressure (the bottom number) below 90 mm Hg.
Measured: 6 months
Secondary outcomes (5)
Blood pressure control at 9 weeks
Percentage of participants whose blood pressure is under control at 9 weeks. Control means systolic blood pressure (the top number) below 140 mm Hg and diastolic blood pressure (the bottom number) below 90 mm Hg.
Measured: 9 weeks
Treatment adherence
Number of days participants take their blood pressure medicine during the 6-month follow-up.
Measured: 6 months
Treatment success
Percentage of participants who have treatment success at 6 months.
Measured: 6 months
Treatment failure
Percentage of participants who have treatment failure during the 6-month follow-up.
Measured: 6 months
Loss to follow-up
Percentage of participants who stop attending follow-up visits and cannot be assessed during the 6-month follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start8 Apr 2025
- Primary completion8 Jun 2025
- Study completion11 Sep 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, cluster randomized trial with two parallel groups. Researchers randomly assigned 23 primary care clinics in Bangladesh and Pakistan in a 2:1 ratio to an mHealth text message program or usual care. All participants at a clinic were in the same group. Participants were followed for 6 months.
- Masking
- None (open label)
- Enrolment
- 1,295 participants (actual)
Sponsor and investigators
- Lead sponsor
- GIFT University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna Iqbal, Bahauddin Zakariya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878728
- Sponsor's protocol ID
- EC524
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research team has not yet decided whether to share individual participant data (IPD) with other researchers. A decision will be made after the main results are published. Any plan will follow the ethics approvals and consent terms of the participating clinics.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Health-Supported Hypertension Management Program on Blood Pressure Control in Primary Care: A Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07878728
- Acronym / sponsor ID
- EC524
- Conditions
- Hypertension, Primary Hypertension
- Keywords
- mHealth, Mobile health, Text messaging (SMS), Blood pressure control Medication adherence, Lifestyle modification, Primary care, Cluster randomized trial, Low- and middle-income countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,295 participants (actual)
- Lead sponsor
- GIFT UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 Jun 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 16 Oct 2026 (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.
The goal of this clinical trial is to learn if text messages can help adults with newly diagnosed high blood pressure (hypertension) bring their blood pressure under control. The study took place in primary care clinics in Bangladesh and Pakistan. The main questions it aims to answer are:
Do more participants who get text messages have their blood pressure under control after 6 months? Under control means a top number below 140 and a bottom number below 90.
Do text messages help participants take their blood pressure medicine as prescribed?
Researchers compared a text message program to usual care to see if the text messages work to lower blood pressure. They randomly assigned whole clinics, not individual people, to one of the two groups.
Participants:
Got text messages for 6 months, or got written health materials and usual care. Received daily messages for the first month and fewer after that, if in the text message group. The messages encouraged taking medicine, healthy habits, and checking blood pressure.
Had their blood pressure checked at 9 weeks and at 6 months.
Detailed description
Hypertension is a major risk factor for heart disease and death worldwide, and it can be treated. But many people with hypertension still do not reach healthy blood pressure levels. This trial tests whether a low-cost text message program can help adults with newly diagnosed hypertension reach blood pressure control in routine primary care.
The trial is multicenter and cluster randomized. Researchers randomly assigned whole primary care clinics, rather than individual participants, to the text message program or usual care. Clinics were assigned in a 2:1 ratio, so twice as many clinics offered the text message program as usual care. Participants were followed for 6 months.
Blood pressure control was the main focus because it is the clinical goal of hypertension treatment. The trial also looked at several other measures of how participants did on treatment. These include blood pressure control at an earlier point (9 weeks), how long participants stayed on their medicine, whether treatment worked or failed, how many participants dropped out of follow-up, and deaths.
Because participants in the same clinic may have similar outcomes, the analysis accounts for clustering by clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, cluster randomized trial with two parallel groups. Researchers randomly assigned 23 primary care clinics in Bangladesh and Pakistan in a 2:1 ratio to an mHealth text message program or usual care. All participants at a clinic were in the same group. Participants were followed for 6 months.
| Arm | Type | Receives |
|---|---|---|
| mHealth Text Message Program | Experimental | Behavioral: mHealth Text Message ProgramParticipants receive text messages for 6 months that encourage taking blood pressure medicine, making healthy lifestyle changes, and checking blood pressure. Messages are sent daily for the first month and less often after that. Participants also receive routine hypertension care at their clinic. |
| Usual Care | Active comparator | Other: Usual CareParticipants receive written educational materials about hypertension and routine hypertension care at their clinic for 6 months. They do not receive text messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diagnosed with primary hypertension within the past 4 weeks
- Receiving care at one of the participating primary care clinics
Key exclusion criteria (6 listed)
- Secondary hypertension
- Recent major cardiovascular event (stroke or heart attack)
- Enrolled in another blood pressure management study or another interventional study
- Serious health conditions that could interfere with participation or with measuring outcomes
- Unable to understand study procedures
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 |
|---|---|---|
| mHealth Text Message ProgramParticipants receive text messages on their mobile phones for 6 months. The messages encourage three things: taking blood pressure medicine as prescribed, making healthy lifestyle changes, and checking blood pressure. Messages are sent daily for the first month and less often after that. Participants receive this program in addition to routine hypertension care at their clinic. | Behavioural | mHealth Text Message Program |
| Usual CareParticipants receive written educational materials about hypertension and routine hypertension care at their clinic for 6 months. They do not receive text messages. | Other | Usual Care |
Primary outcome
Blood pressure control at 6 months
Time frame: 6 months
Percentage of participants whose blood pressure is under control at 6 months. Control means systolic blood pressure (the top number) below 140 mm Hg and diastolic blood pressure (the bottom number) below 90 mm Hg.
5 secondary outcomes
Blood pressure control at 9 weeks
Time frame: 9 weeks
Treatment adherence
Time frame: 6 months
Treatment success
Time frame: 6 months
Treatment failure
Time frame: 6 months
Loss to follow-up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided. The research team has not yet decided whether to share individual participant data (IPD) with other researchers. A decision will be made after the main results are published. Any plan will follow the ethics approvals and consent terms of the participating clinics.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Text Message Program in people with Hypertension and Primary Hypertension, run by GIFT University at 1 site in Pakistan.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure control at 6 months (time frame: 6 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 26 Oct 2026.