Technology for Innovative Monitoring of Cardiovascular Prevention: a RCT

Prehypertension Clinical Trial

— TIM  

Official title:

Technology for Innovative Monitoring of Cardiovascular Prevention: A Precision Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03005470
• Other study ID #: CAAE: 31423214.0.0000.5327
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 23, 2016
• Last updated: April 24, 2018
• Start date: January 2017
• Est. completion date: February 2019

Study information

• Verified date: April 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 231
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure, High
• Hypertension
• Prehypertension

Intervention

Device:
• TELEM
Participants in the telemonitoring home blood pressure (TELEM) group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made early in the morning (5:00 to 10:00) and in the evening (18:00 to 21:00) for at least five days a week (including one day during the weekend). Each blood pressure measure will be sent to the center of the study coordination center through software downloaded on the participant's smartphone.
• TELEMEV
In the lifestyle telemonitoring group (TELEMEV), participants will receive customized standardized text messages to stimulate lifestyle changes and adherence to blood pressure lowering medication. The messages will be focused on the adoption of DASH diet, sodium restriction, increase of physical activity, weight control and adherence to drug treatment. They will be sent out on four of the five days of the week at random times. The messages will be sent to the smarphones through a software developed for this study.
• TELEM-TELEMEV
Participants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described.

Other:
• UCT
Participants in the control group will receive usual clinical treatment (UCT) on pre-scheduled visits, but will not receive any technological tool to stimulate blood pressure control or lifestyle modification.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure monitoring (ABPM)	Reduction in 24h-systolic blood pressure	Change at six months (end of the trial)
Secondary	ABPM	Reduction in 24h-diastolic blood pressure	Change at six months (end of the trial)
Secondary	Other ABPM measurements	Reduction in daytime and nighttime systolic blood pressure	Change from baseline to end of the trial
Secondary	Office blood pressure	Office blood pressure control rate: <130/80 mmHg	At six months (end of the trial)
Secondary	Reduction in sodium urinary excretion	Reduction in sodium urinary excretion in a urinary spot	Change at six months (end of the trial)
Secondary	Improvement of lifestyle: increase of regular physical activity, intake of DASH-type diet, or weight reduction	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	Change at six months (end of the trial)