HypertensionNCT03524456
Home Blood Pressure SMS Telemonitoring in the Primary Care Setting
A study testing Home blood pressure monitoring in people with Hypertension, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
Hypertension is a public health problem worldwide, being responsible for 9.4 million deaths worldwide each year, as well as contributing to the burden of coronary, cerebrovascular, renal diseases, among others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Home blood pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePeru
- Study dates
- 9 Apr 2018to 29 Sep 2018
- 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
- Older than 18 years-old.
- Diagnosis of hypertension more than 3 months ago.
- Not Controlled hypertension
- In antihypertensive medication
Who cannot join
- Patient with chronic kidney disease on hemodialysis or peritoneal dialysis.
- Pregnant women.
- Travel or change of address in the next 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Blood Pressure Telemonitoring With an Adapted Device With SMS Capability in the Primary Care Setting
Hypertension is a public health problem worldwide, being responsible for 9.4 million deaths worldwide each year, as well as contributing to the burden of coronary, cerebrovascular, renal diseases, among others. The monitoring of blood pressure at home has gained importance in recent years, being related to adherence to treatment, as well as in the prevention of complications and optimization of pressure levels; In the same way, the use of information and communication technologies (ICT) in health has contributed to the improvement of communication systems by providing alternative tele-monitoring in this type of diseases.
Objective:
Read more
To evaluate the impact of tele-monitoring at home through tensiometers with integrated SMS system (text message), for the sending and recording of blood pressure and heart rate data in the primary care setting.
Methods:
A randomized controlled trial will be conducted, evaluating the intervention with the integrated blood pressure device with SMS capability, comparing it with the standard care. After a follow-up of 1 month, the effect on the values of systolic and diastolic blood pressure will be evaluated, as well as the adherence to treatment and complications related to arterial hypertension. A sample number of 20 participants per group was calculated, with a significance of 95% and a power of 80%, to detect a minimum significant difference of 10 mmHg.
Read the detailed description
Objectives
Main Objective:
To evaluate the impact of the home blood pressure telemonitoring through a device with integrated SMS system, in blood pressure values in uncontrolled hypertensive patients.
Secondary objectives:
- Compare adherence to treatment at the beginning and end of the follow-up between the group that uses integrated tele-monitoring with SMS and the usual monitoring.
- Describe the experiences of the participants of the intervention group with the tele-monitoring system.
Methods
Study design: A randomized controlled trial will be conducted, which will be followed for 1 month. The main measurement will be to evaluate the difference in blood pressure levels in both groups at the end of the follow-up, the intervention group would use the device for 2 weeks.
Intervention group: Tele-monitoring with sphygmomanometer with SMS capacity Control group: Regular monitoring Follow-up time: 1 month Primary Outcome: Difference in systolic and diastolic blood pressure
Population: Hypertensive patients who attend a Primary Care Centers:
Condevilla Health Center
Inclusion criteria:
Older than 18 years-old. Diagnosis of hypertension more than 3 months ago. Not Controlled In antihypertensive medication
Exclusion criteria:
Patient with chronic kidney disease on hemodialysis or peritoneal dialysis. Pregnant women. Travel or change of address in the next 1 month.
Sample:
A sample of 20 participants per group was calculated, with a significance of 95% and a power of 80%, to show a difference of 10 mmHg, with a standard deviation of 10 and 12 according to the literature evaluated.
Assignment of groups:
A selection of patients will be made in the clinic of the health centers. If the inclusion and exclusion criteria are met, they will be invited to participate in the study, after accepting and signing the informed consent, a randomization will be made for complete blocks of 4 (2 controls, 2 interventions) until the total of 40 participants is reached, 20 in the intervention group and 20 in the control group.
Intervention group:
Participants will receive general education on hypertension and general care as well as training for the use of the tensiometer and a graphic guide provided by the manufacturer of the tensiometer.
The participants of the intervention group will receive a commercial blood pressure monitor "Omron Series 10®" which was integrated into an SMS messaging system using open hardware developing boards.
The measurement scheme will be programmed 4 times a day: 2 in the morning, and 2 in the evening with a 3-minute interval. If no record is received in 24hrs, specific reminder text messages will be sent to the patient, caregiver and/or relative, if after 2 days, there is no measurement, the patient will be contacted by phone and / or caregiver / family.
The SMS of the tensiometer to the information center will include the following data:
Systolic blood pressure Diastolic blood pressure Heart Rate Date Hour
The sphygmomanometer SMS will be sent to the information and monitoring center that will be hosted on a server in the cloud. The information and monitoring system will store blood pressure records and would be accessible to the primary care centers physicians, they would be free to any decision making regarding treatment adjustment or scheduling visits to the patients.
Development of tensiometer with SMS capacity:
An information acquisition and SMS sending station capable of capturing the tensiometer measurement will be developed using Arduino ® development cards.
The tensiometer will be linked through its USB interface to the development board, which in turn will send the blood pressure data automatically.
It should be mentioned that the operation of the tensiometer has not been altered, and remains the same as that recommended by the manufacturer. At the end of the pressure collection, the data will be sent automatically.
Control group:
The control group will receive the same educational session, and the usual monitoring in Health Centers will continue.
Outcome:
The difference in blood pressure values will be made, after 1 month of follow-up, under the same conditions as the initial measurement, as well as adherence to treatment, complications, and compliance with scheduled appointments during follow-up.
Analysis plan:
The primary statistical analysis will be a Mann-Whitney test of two independent samples comparing the change in blood pressure measured between the baseline and after 1 month of follow-up.
A secondary analysis of medication differences, adherence to treatment, complications, and fulfillment of appointments will be made, between the 2 study groups The level of significance will be given by a value of p <0.05.
Ethical aspects
Written informed consent will be requested from participants and caregivers / relatives.
The equipment will include a SIM card that will be recharged by the researchers of the study, as well as the cost of the equipment and the messaging packages will be covered by the researchers throughout the follow-up.
The present protocol will be presented to the CIE of the UPCH as well as to the CIE of the HNCH for its approval.
The data obtained will be confidential, the personal identifiers will be separated from the analysis database, which will be stored in a separate database, stored with a password to which only the researchers will have access. The SMS data will be sent in an encrypted way so that it can only be read by the information center.
- Conditions
- Hypertension
- Being tested
- Home blood pressure monitoring
- Keywords
- home blood pressure monitoring, sms, primary care
- Medical subject headings
- Hypertension, Smith-Magenis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home blood pressure monitoringOther
Participants would use a blood pressure device at home, that sends the readings automatically to the health center via SMS. The physicians would use this tool for medication management or rescheduling visits.
| Study group | Role | What they receive |
|---|---|---|
| Home blood pressure monitoring | Experimental | Not described Receives: Other: Home blood pressure monitoring |
| Usual monitoring | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood pressure diference before and after the intervention period between the control and intervention arm
Changes in the blood pressure levels would be compare in both study groups
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start9 Apr 2018
- Primary completion29 Aug 2018
- Study completion29 Sep 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renzo Calderon, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524456
- Sponsor's protocol ID
- 101180
- Status last verified
- May 2019
- First submitted
- 2 May 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Blood Pressure Telemonitoring With an Adapted Device With SMS Capability in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT03524456
- Acronym / sponsor ID
- 101180
- Conditions
- Hypertension
- Keywords
- home blood pressure monitoring, sms, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 14 May 2018 (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.
Hypertension is a public health problem worldwide, being responsible for 9.4 million deaths worldwide each year, as well as contributing to the burden of coronary, cerebrovascular, renal diseases, among others. The monitoring of blood pressure at home has gained importance in recent years, being related to adherence to treatment, as well as in the prevention of complications and optimization of pressure levels; In the same way, the use of information and communication technologies (ICT) in health has contributed to the improvement of communication systems by providing alternative tele-monitoring in this type of diseases.
Objective:
To evaluate the impact of tele-monitoring at home through tensiometers with integrated SMS system (text message), for the sending and recording of blood pressure and heart rate data in the primary care setting.
Methods:
A randomized controlled trial will be conducted, evaluating the intervention with the integrated blood pressure device with SMS capability, comparing it with the standard care. After a follow-up of 1 month, the effect on the values of systolic and diastolic blood pressure will be evaluated, as well as the adherence to treatment and complications related to arterial hypertension. A sample number of 20 participants per group was calculated, with a significance of 95% and a power of 80%, to detect a minimum significant difference of 10 mmHg.
Detailed description
Objectives
Main Objective:
To evaluate the impact of the home blood pressure telemonitoring through a device with integrated SMS system, in blood pressure values in uncontrolled hypertensive patients.
Secondary objectives:
- Compare adherence to treatment at the beginning and end of the follow-up between the group that uses integrated tele-monitoring with SMS and the usual monitoring.
- Describe the experiences of the participants of the intervention group with the tele-monitoring system.
Methods
Study design: A randomized controlled trial will be conducted, which will be followed for 1 month. The main measurement will be to evaluate the difference in blood pressure levels in both groups at the end of the follow-up, the intervention group would use the device for 2 weeks.
Intervention group: Tele-monitoring with sphygmomanometer with SMS capacity Control group: Regular monitoring Follow-up time: 1 month Primary Outcome: Difference in systolic and diastolic blood pressure
Population: Hypertensive patients who attend a Primary Care Centers:
Condevilla Health Center
Inclusion criteria:
Older than 18 years-old. Diagnosis of hypertension more than 3 months ago. Not Controlled In antihypertensive medication
Exclusion criteria:
Patient with chronic kidney disease on hemodialysis or peritoneal dialysis. Pregnant women. Travel or change of address in the next 1 month.
Sample:
A sample of 20 participants per group was calculated, with a significance of 95% and a power of 80%, to show a difference of 10 mmHg, with a standard deviation of 10 and 12 according to the literature evaluated.
Assignment of groups:
A selection of patients will be made in the clinic of the health centers. If the inclusion and exclusion criteria are met, they will be invited to participate in the study, after accepting and signing the informed consent, a randomization will be made for complete blocks of 4 (2 controls, 2 interventions) until the total of 40 participants is reached, 20 in the intervention group and 20 in the control group.
Intervention group:
Participants will receive general education on hypertension and general care as well as training for the use of the tensiometer and a graphic guide provided by the manufacturer of the tensiometer.
The participants of the intervention group will receive a commercial blood pressure monitor "Omron Series 10®" which was integrated into an SMS messaging system using open hardware developing boards.
The measurement scheme will be programmed 4 times a day: 2 in the morning, and 2 in the evening with a 3-minute interval. If no record is received in 24hrs, specific reminder text messages will be sent to the patient, caregiver and/or relative, if after 2 days, there is no measurement, the patient will be contacted by phone and / or caregiver / family.
The SMS of the tensiometer to the information center will include the following data:
Systolic blood pressure Diastolic blood pressure Heart Rate Date Hour
The sphygmomanometer SMS will be sent to the information and monitoring center that will be hosted on a server in the cloud. The information and monitoring system will store blood pressure records and would be accessible to the primary care centers physicians, they would be free to any decision making regarding treatment adjustment or scheduling visits to the patients.
Development of tensiometer with SMS capacity:
An information acquisition and SMS sending station capable of capturing the tensiometer measurement will be developed using Arduino ® development cards.
The tensiometer will be linked through its USB interface to the development board, which in turn will send the blood pressure data automatically.
It should be mentioned that the operation of the tensiometer has not been altered, and remains the same as that recommended by the manufacturer. At the end of the pressure collection, the data will be sent automatically.
Control group:
The control group will receive the same educational session, and the usual monitoring in Health Centers will continue.
Outcome:
The difference in blood pressure values will be made, after 1 month of follow-up, under the same conditions as the initial measurement, as well as adherence to treatment, complications, and compliance with scheduled appointments during follow-up.
Analysis plan:
The primary statistical analysis will be a Mann-Whitney test of two independent samples comparing the change in blood pressure measured between the baseline and after 1 month of follow-up.
A secondary analysis of medication differences, adherence to treatment, complications, and fulfillment of appointments will be made, between the 2 study groups The level of significance will be given by a value of p <0.05.
Ethical aspects
Written informed consent will be requested from participants and caregivers / relatives.
The equipment will include a SIM card that will be recharged by the researchers of the study, as well as the cost of the equipment and the messaging packages will be covered by the researchers throughout the follow-up.
The present protocol will be presented to the CIE of the UPCH as well as to the CIE of the HNCH for its approval.
The data obtained will be confidential, the personal identifiers will be separated from the analysis database, which will be stored in a separate database, stored with a password to which only the researchers will have access. The SMS data will be sent in an encrypted way so that it can only be read by the information center.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home blood pressure monitoring | Experimental | Other: Home blood pressure monitoring |
| Usual monitoring | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years-old.
- Diagnosis of hypertension more than 3 months ago.
- Not Controlled hypertension
- In antihypertensive medication
Key exclusion criteria (3 listed)
- Patient with chronic kidney disease on hemodialysis or peritoneal dialysis.
- Pregnant women.
- Travel or change of address in the next 4 weeks
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 |
|---|---|---|
| Home blood pressure monitoringParticipants would use a blood pressure device at home, that sends the readings automatically to the health center via SMS. The physicians would use this tool for medication management or rescheduling visits. | Other | Home blood pressure monitoring |
Primary outcome
Comparison of blood pressure diference before and after the intervention period between the control and intervention arm
Time frame: 1 month
Changes in the blood pressure levels would be compare in both study groups
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 7 May 2019.
- Individual participant dataSharing planned: Undecided
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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 Home blood pressure monitoring in people with Hypertension, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 4 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: finished, as of the sponsor's last update on 7 May 2019. 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 Peru. 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?
Comparison of blood pressure diference before and after the intervention period between the control and intervention arm (time frame: 1 month). 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 7 May 2019.