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
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.
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.
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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|
- 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
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
|Centro de Salud Condevilla|