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Home Blood Pressure SMS Telemonitoring in the Primary Care Setting

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ClinicalTrials.gov Identifier: NCT03524456
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Renzo Calderon, Universidad Peruana Cayetano Heredia

Tracking Information
First Submitted Date  ICMJE May 2, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE April 9, 2018
Actual Primary Completion Date August 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Blood pressure diference [ Time Frame: 1 month ]
Changes in the blood pressure levels would be compare in both study groups
Change History Complete list of historical versions of study NCT03524456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Blood Pressure SMS Telemonitoring in the Primary Care Setting
Official Title  ICMJE Home Blood Pressure Telemonitoring With an Adapted Device With SMS Capability in the Primary Care Setting
Brief 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. 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:

  1. 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.
  2. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hypertension
Intervention  ICMJE Other: Home blood pressure monitoring
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 Arms  ICMJE
  • Experimental: Home blood pressure monitoring
    Intervention: Other: Home blood pressure monitoring
  • No Intervention: Usual monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 29, 2018
Actual Primary Completion Date August 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Older than 18 years-old.
  • Diagnosis of hypertension more than 3 months ago.
  • Not Controlled hypertension
  • 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 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03524456
Other Study ID Numbers  ICMJE 101180
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Renzo Calderon, Universidad Peruana Cayetano Heredia
Study Sponsor  ICMJE Universidad Peruana Cayetano Heredia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad Peruana Cayetano Heredia
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP