Technology for Innovative Monitoring of Cardiovascular Prevention: a RCT

Phase 3

• Conditions: Prehypertension; Blood Pressure, High

• Registration Number: NCT03005470
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

National and international guidelines that guide evidence-based clinical practice advocate an effort to improve blood pressure control based on changing lifestyle and use of blood pressure lowering medication. However, the effectiveness of the approach usually depends on patient adherence to both types of interventions - pharmacological and behavioral. Lack of success on blood pressure control has increased the scope of interventions to improve adherence and to reduce cardiovascular risk factors without overburdening the public health system. The use of technologies - mobile or smart phones, games, blogs, internet and video conferencing - to implement interventions can reduce costs and increase coverage.

Interactive interventions have been associated with a reduction in systolic blood pressure of 3-8 mmHg in patients with hypertension. These interventions were individually tailored to patient specificities and involved self-monitoring of blood pressure and lifestyle changes, including regular physical activity, DASH diet, restriction of dietary salt intake, and weight control. However, the effectiviness of these interventions may have short half-lives without periodic reinforcement, either to adhere to pharmacological treatment or behavioral changes. Innovative technologies can be used to achieve lasting effect and even greater blood pressure reduction.

Therefore, the purpose of this study is to compare effectiveness of four strategies to reduce blood pressure and improve lifestyle.

Detailed Description

This is a factorial randomized controlled trial of comparative effectiveness and precision medicine. Participants will be randomly assigned in a ratio of 1:1:2:1 to one of four arms: telemonitoring of blood pressure by smart phone, text message for lifestyle changes, both interventions (telemonitoring and messages) or usual clinical care. At randomization, all participants will receive a printed booklet with lifestyle modification guidelines. The standardized recommendation to adhere to the pharmacological treatment prescribed by the attending physician will also be implemented. These types of interventions do not allow the research assistant responsible for monitoring to be blinded, but the researcher resposible for the assessment of the outcome will be blinded to the allocated arm and the results will be evaluated through objective measurements.

Study Timeline

• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2016-12-23
• Study First Posted: 2016-12-29
• Study Start: 2017-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26
• Primary Completion: 2019-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

• Office blood pressure: systolic blood pressure greater or equal to 135 mmHg and below 180 mmHg or diastolic blood pressure greater or equal to 85 mmhg and below 110 mmhg
• Ambulatory Blood Pressure Monitoring (ABPM): 24h-SBP ≥130 mmHg or 24h-DBP ≥80 mmHg
• Use of one or two blood pressure lowering drugs
• Have a smartphone

Exclusion Criteria

• Cardiovascular event in the last 6 months (eg myocardial infarction, stroke, pacemaker or other use)
• Life threatening conditions, low life expectancy
• Inability to measure blood pressure;
• Previous diagnosis of secondary hypertension;
• IF WOMAN: lactating, pregnancy or who intend to become pregnant within the next 6 months.
• Unable to understand the interventions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Ambulatory blood pressure monitoring (ABPM)	Change at six months (end of the trial)	Reduction in 24h-systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Other ABPM measurements	Change from baseline to end of the trial	Reduction in daytime and nighttime systolic blood pressure
Office blood pressure	At six months (end of the trial)	Office blood pressure control rate: \<130/80 mmHg
Reduction in sodium urinary excretion	Change at six months (end of the trial)	Reduction in sodium urinary excretion in a urinary spot
Improvement of lifestyle: increase of regular physical activity, intake of DASH-type diet, or weight reduction	Change at six months (end of the trial)	Increase in average steps taken during 7 days, using pedometer; reported dietary intake using 24h recall of food groups; reduction of reported intake, using a quantitative questionnaire; or reduction of at least 3 kg or the average reduction
ABPM	Change at six months (end of the trial)	Reduction in 24h-diastolic blood pressure

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil