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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Other: Home blood pressure monitoring Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Home Blood Pressure Telemonitoring With an Adapted Device With SMS Capability in the Primary Care Setting
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : September 29, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Home blood pressure monitoring 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.
No Intervention: Usual monitoring


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524456


Locations
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Peru
Centro de Salud Condevilla
Lima, Peru
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
More Information
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Responsible Party: Renzo Calderon, Researcher, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT03524456     History of Changes
Other Study ID Numbers: 101180
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Renzo Calderon, Universidad Peruana Cayetano Heredia:
home blood pressure monitoring
sms
primary care
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases