Home Blood Pressure SMS Telemonitoring in the Primary Care Setting

NCT03524456 | Completed DMC

• 1 other identifier: 101180
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

home blood pressure monitoring; sms; primary care

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Study Arms (2)

Home blood pressure monitoring

EXPERIMENTAL

Other: Home blood pressure monitoring

Usual monitoring

NO INTERVENTION

Interventions

Home blood pressure monitoring OTHER

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.

Home blood pressure monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years-old.
• Diagnosis of hypertension more than 3 months ago.
• Not Controlled hypertension
• In antihypertensive medication

You may not qualify if:

• Patient with chronic kidney disease on hemodialysis or peritoneal dialysis.
• Pregnant women.
• Travel or change of address in the next 4 weeks

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead

Study Sites (1)

Centro de Salud Condevilla

Lima, Peru

Location

MeSH Terms

Conditions

Hypertension; Smith-Magenis Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Chronobiology Disorders; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 14, 2018
• Study Start: April 9, 2018
• Primary Completion: August 29, 2018
• Study Completion: September 29, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

PE (1)