HypertensionNCT01255436
Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension
A study testing SMS text reminders in people with Hypertension, run by University of the Philippines at 1 site in Philippines.
Trial summary
Objective: To test the primary hypothesis that SMS text messages delivered to patients via mobile phone can improve blood pressure within 12 weeks compared to usual care Design: Parallel group, randomized, controlled trial; the patient is the unit of randomization Setting: General Medicine Outpatient Continuity Clinic… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- SMS text reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 sitePhilippines
- Study dates
- Jan 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory adult patients of both sexes with age at least 19 years old being seen at the General Medicine Outpatient Clinic of the Philippine General Hospital
- A diagnosis of hypertension in the medical record
- On at least 1 maintenance medication for hypertension for at least 1 month
- A systolic blood pressure greater than 129 mmHg and less than 160 mmHg or a diastolic blood pressure greater than 79 mmHg or less than 100 mmHg at the time of screening
- Patients with daily access to a mobile phone in the household
- Patients who live with someone who knows how to retrieve and read text messages on their mobile phone, and can relay these messages to them
- Written informed consent
Who cannot join
- Participation in other studies within one month of trial initiation
- Patients who are unable or refuse to give informed consent
- Patients who have a clinical condition that might interfere with the study (dementia, psychological disorder)
- Patients who share a household with another patient who has already been recruited to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension at a General Medicine Outpatient Clinic in a Tertiary Center in Manila, Philippines: A Randomized Controlled Trial
Objective: To test the primary hypothesis that SMS text messages delivered to patients via mobile phone can improve blood pressure within 12 weeks compared to usual care
Design: Parallel group, randomized, controlled trial; the patient is the unit of randomization
Read more
Setting: General Medicine Outpatient Continuity Clinic of the Philippine General Hospital and Private Outpatient Clinics near the Philippine General Hospital
Patients: Ambulatory men and women aged 19 years and older (N=700) with a diagnosis of essential hypertension, on maintenance blood pressure-lowering medications, who have daily access to a mobile phone in the household and know or live with someone who knows how to retrieve, read and reply to text messages using a mobile phone
Intervention: SMS text messages delivered twice a week for 12 weeks, which aim to 1) provide information regarding hypertension; 2) remind patients to take their medications.
Main Outcome Measure: The primary outcomes are the mean change in systolic and diastolic blood pressures at the end of 12 weeks. The secondary outcomes are improvement in blood pressure control rate and medication adherence.
Read the detailed description
The study will be done in 2 phases:
Phase I: Development of the SMS text messages
The SMS messages to be used in the trial will be developed and pre-tested in focus group discussions of a convenience sample of subjects similar to the target population for understandability and acceptability.
Phase II: Parallel group, open-label, randomized, controlled trial
Target Population
Hypertensive patients being seen at the General Medicine Outpatient Clinic of a public, tertiary, university hospital in Manila, Philippines
Sampling Method
A criterion sampling strategy will be used in the study. Patients who fulfill the eligibility criteria will be recruited consecutively until the desired sample size is reached.
Randomization and Allocation Concealment
Eligible patients will be randomized to one of two treatment groups using a computer-generated random allocation sequence. Allocation of treatment will be done by a third party using sequential, sealed opaque envelopes.
Blinding
Given the nature of the intervention, patients will not be blinded to the treatment groups. However, measures will be taken to blind the physicians managing the participants at the clinic. Outcome assessors will also be blinded to the participants' treatment groups.
Procedures and Measurements
Written, informed consent will be obtained prior to enrolment in the study. Once an eligible participant has given consent, he will be randomized to either the intervention or control arm of the trial by a third party using sequentially numbered opaque envelopes. At the end of a 12-week follow up period, participants will be asked to return for a final study visit, where blood pressure and medication adherence will be measured. Acceptability of the SMS intervention will also be determined using a structured questionnaire. A period of four weeks from scheduled date of final visit is allowed before a patient is considered to have been lost to follow-up.
Intervention: SMS reminders
Patients in the intervention arm will receive 2 text messages per week delivered via SMS on randomly chosen days and times during the 12-week study period. The aims of the messages are to remind patients to take their blood pressure medications daily, what the target blood pressure is, and the benefits of daily intake of anti-hypertensive medications. Successful contact will be assumed when "Message sent" is seen on the screen. Otherwise, the same text message shall be immediately resent up to a maximum of 3 times. Receipt of the messages will be free to the study participants and independent of their telephone service provider.
Control: Usual Care
Routine or usual care of hypertensive patients at the General Medicine Outpatient clinic is based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. This consists of physician visits, advice and medication prescription by the healthcare provider. It does not include sending SMS messages to encourage adherence and provide information regarding hypertension.
Outcome Measurements
Blood Pressure
Blood pressure will be measured using a calibrated digital sphygmomanometer manufactured by Omron after the participant has been seated quietly for five minutes. The average of two readings taken five minutes apart will be recorded.
Medication Adherence
The Adherence Self-Report Questionnaire (ASRQ), a brief, validated, self-administered questionnaire, will be used to measure medication adherence. Participants will be asked to complete the Filipino translation of the ASRQ.
Acceptability of SMS Messages
Acceptability of the SMS messages will be measured using a brief, self-administered questionnaire.
Planned Analysis
Descriptive statistics for baseline characteristics, adherence scores, and adherence rates in both groups (mean, sd, frequency (%), median) will be computed. Between-group comparisons will be done at baseline to check for similarity of baseline characteristics, and at the end of 12 weeks to test the hypothesis of inequality between two populations. All hypothesis tests will be one-sided with a level of significance set at 0.05. Intention-to-treat (ITT) analysis will be done, with possible sensitivity analysis for drop-outs. All statistical computations will be computed using the Stata statistical software.
Sample Size
The NCSS-PASS statistical software was used to compute for the desired sample size.
The sample size required to fulfill the objectives of the study is 286 subjects per group. Allowing for a loss to follow up of approximately 20%, the final sample size is 350 subjects per group (total of 700 subjects).
Ethical Considerations
Ethics approval will be obtained prior to conducting this study. Written informed consent will be obtained from all participants prior to enrolment. Good clinical practice guidelines will be followed during the course of the study.
At the beginning of the trial, it will be emphasised that communication through SMS in this study is one-way (provider to patient), so there will be no reply to any and all text messages received from participants. The participants will also be advised to consult their physicians for any problems they may experience.
- Conditions
- Hypertension
- Being tested
- SMS text reminders, Usual Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS text remindersOther
Patients in the intervention arm will receive 2 text messages per week delivered via SMS on randomly chosen days and times during the 12-week study period. The aims of the messages are to remind patients to take their blood pressure medications daily, what the target blood pressure is, and the benefits of daily intake of anti-hypertensive medications.
Usual CareOther
Also called No SMS text reminders
Patients in the usual care arm will receive the care usually provided by their physicians. This consists of consultations, medical advice, and prescriptions for maintenance medications. They will not be sent any SMS text reminders from the study.
| Study group | Role | What they receive |
|---|---|---|
| SMS text reminders | Experimental | Participants in this arm will receive SMS text messages on top of the usual care they receive from their physicians. Receives: Other: SMS text reminders |
| Usual Care | Other | Participants in this arm will receive the usual care they receive from their physicians. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Absolute Change in Systolic Blood Pressure After 12 Weeks
Absolute change in systolic blood pressure from baseline to 12 weeks
Measured: baseline and 12 weeks
Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks
Absolute change in diastolic blood pressure from baseline to 12 weeks
Measured: baseline and 12 weeks
Secondary outcomes (2)
Medication Adherence Rate
The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire at the end of 12 weeks Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)
Measured: 12 weeks
Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks
The percentage of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg at the end of 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Philippines
- Responsible party
- Principal investigator, Lia M. Palileo, University of the Philippines
- Investigators
- Lia M. Palileo, MD, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255436
- Sponsor's protocol ID
- GCS IM 2010-002 (R-006TE)
- Status last verified
- Jan 2017
- First submitted
- 6 Dec 2010
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of SMS Text Reminders to Improve Blood Pressure Among Patients With Hypertension at a General Medicine Outpatient Clinic in a Tertiary Center in Manila, Philippines: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01255436
- Acronym / sponsor ID
- GCS IM 2010-002 (R-006TE)
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Department of Health, Philippines
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Posted 2 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To test the primary hypothesis that SMS text messages delivered to patients via mobile phone can improve blood pressure within 12 weeks compared to usual care
Design: Parallel group, randomized, controlled trial; the patient is the unit of randomization
Setting: General Medicine Outpatient Continuity Clinic of the Philippine General Hospital and Private Outpatient Clinics near the Philippine General Hospital
Patients: Ambulatory men and women aged 19 years and older (N=700) with a diagnosis of essential hypertension, on maintenance blood pressure-lowering medications, who have daily access to a mobile phone in the household and know or live with someone who knows how to retrieve, read and reply to text messages using a mobile phone
Intervention: SMS text messages delivered twice a week for 12 weeks, which aim to 1) provide information regarding hypertension; 2) remind patients to take their medications.
Main Outcome Measure: The primary outcomes are the mean change in systolic and diastolic blood pressures at the end of 12 weeks. The secondary outcomes are improvement in blood pressure control rate and medication adherence.
Detailed description
The study will be done in 2 phases:
Phase I: Development of the SMS text messages
The SMS messages to be used in the trial will be developed and pre-tested in focus group discussions of a convenience sample of subjects similar to the target population for understandability and acceptability.
Phase II: Parallel group, open-label, randomized, controlled trial
Target Population
Hypertensive patients being seen at the General Medicine Outpatient Clinic of a public, tertiary, university hospital in Manila, Philippines
Sampling Method
A criterion sampling strategy will be used in the study. Patients who fulfill the eligibility criteria will be recruited consecutively until the desired sample size is reached.
Randomization and Allocation Concealment
Eligible patients will be randomized to one of two treatment groups using a computer-generated random allocation sequence. Allocation of treatment will be done by a third party using sequential, sealed opaque envelopes.
Blinding
Given the nature of the intervention, patients will not be blinded to the treatment groups. However, measures will be taken to blind the physicians managing the participants at the clinic. Outcome assessors will also be blinded to the participants' treatment groups.
Procedures and Measurements
Written, informed consent will be obtained prior to enrolment in the study. Once an eligible participant has given consent, he will be randomized to either the intervention or control arm of the trial by a third party using sequentially numbered opaque envelopes. At the end of a 12-week follow up period, participants will be asked to return for a final study visit, where blood pressure and medication adherence will be measured. Acceptability of the SMS intervention will also be determined using a structured questionnaire. A period of four weeks from scheduled date of final visit is allowed before a patient is considered to have been lost to follow-up.
Intervention: SMS reminders
Patients in the intervention arm will receive 2 text messages per week delivered via SMS on randomly chosen days and times during the 12-week study period. The aims of the messages are to remind patients to take their blood pressure medications daily, what the target blood pressure is, and the benefits of daily intake of anti-hypertensive medications. Successful contact will be assumed when "Message sent" is seen on the screen. Otherwise, the same text message shall be immediately resent up to a maximum of 3 times. Receipt of the messages will be free to the study participants and independent of their telephone service provider.
Control: Usual Care
Routine or usual care of hypertensive patients at the General Medicine Outpatient clinic is based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. This consists of physician visits, advice and medication prescription by the healthcare provider. It does not include sending SMS messages to encourage adherence and provide information regarding hypertension.
Outcome Measurements
Blood Pressure
Blood pressure will be measured using a calibrated digital sphygmomanometer manufactured by Omron after the participant has been seated quietly for five minutes. The average of two readings taken five minutes apart will be recorded.
Medication Adherence
The Adherence Self-Report Questionnaire (ASRQ), a brief, validated, self-administered questionnaire, will be used to measure medication adherence. Participants will be asked to complete the Filipino translation of the ASRQ.
Acceptability of SMS Messages
Acceptability of the SMS messages will be measured using a brief, self-administered questionnaire.
Planned Analysis
Descriptive statistics for baseline characteristics, adherence scores, and adherence rates in both groups (mean, sd, frequency (%), median) will be computed. Between-group comparisons will be done at baseline to check for similarity of baseline characteristics, and at the end of 12 weeks to test the hypothesis of inequality between two populations. All hypothesis tests will be one-sided with a level of significance set at 0.05. Intention-to-treat (ITT) analysis will be done, with possible sensitivity analysis for drop-outs. All statistical computations will be computed using the Stata statistical software.
Sample Size
The NCSS-PASS statistical software was used to compute for the desired sample size.
The sample size required to fulfill the objectives of the study is 286 subjects per group. Allowing for a loss to follow up of approximately 20%, the final sample size is 350 subjects per group (total of 700 subjects).
Ethical Considerations
Ethics approval will be obtained prior to conducting this study. Written informed consent will be obtained from all participants prior to enrolment. Good clinical practice guidelines will be followed during the course of the study.
At the beginning of the trial, it will be emphasised that communication through SMS in this study is one-way (provider to patient), so there will be no reply to any and all text messages received from participants. The participants will also be advised to consult their physicians for any problems they may experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS text reminders | Experimental | Other: SMS text remindersParticipants in this arm will receive SMS text messages on top of the usual care they receive from their physicians. |
| Usual Care | Other | Other: Usual CareParticipants in this arm will receive the usual care they receive from their physicians. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ambulatory adult patients of both sexes with age at least 19 years old being seen at the General Medicine Outpatient Clinic of the Philippine General Hospital
- A diagnosis of hypertension in the medical record
- On at least 1 maintenance medication for hypertension for at least 1 month
- A systolic blood pressure greater than 129 mmHg and less than 160 mmHg or a diastolic blood pressure greater than 79 mmHg or less than 100 mmHg at the time of screening
- Patients with daily access to a mobile phone in the household
Key exclusion criteria (4 listed)
- Participation in other studies within one month of trial initiation
- Patients who are unable or refuse to give informed consent
- Patients who have a clinical condition that might interfere with the study (dementia, psychological disorder)
- Patients who share a household with another patient who has already been recruited to participate in this study
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 |
|---|---|---|
| SMS text remindersPatients in the intervention arm will receive 2 text messages per week delivered via SMS on randomly chosen days and times during the 12-week study period. The aims of the messages are to remind patients to take their blood pressure medications daily, what the target blood pressure is, and the benefits of daily intake of anti-hypertensive medications. | Other | SMS text reminders |
| Usual CareAlso: No SMS text remindersPatients in the usual care arm will receive the care usually provided by their physicians. This consists of consultations, medical advice, and prescriptions for maintenance medications. They will not be sent any SMS text reminders from the study. | Other | Usual Care |
Primary outcome
Mean Absolute Change in Systolic Blood Pressure After 12 Weeks
Time frame: baseline and 12 weeks
Absolute change in systolic blood pressure from baseline to 12 weeks
Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks
Time frame: baseline and 12 weeks
Absolute change in diastolic blood pressure from baseline to 12 weeks
2 secondary outcomes
Medication Adherence Rate
Time frame: 12 weeks
Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lia M. Palileo, MD principal investigator
University of the Philippines Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS text reminders in people with Hypertension, run by University of the Philippines at 1 site in Philippines.
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 7 inclusion and 4 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 23 Feb 2017. 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 Philippines. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Absolute Change in Systolic Blood Pressure After 12 Weeks (time frame: baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 23 Feb 2017.