Technology for Innovative Monitoring of Cardiovascular Prevention: a RCT (TIM)

April 24, 2018 updated by: Sandra Costa Fuchs, Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

231

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TELEM group
Participants in the telemonitoring home blood pressure group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made 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.
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.
EXPERIMENTAL: TELEMEV group
In the telemonitoring of lifestyle group, 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 to the smarphones on four of the five days of the week at random times using a software developed for this study.
Device: 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.
EXPERIMENTAL: TELEM-TELEMEV group
Participants in the telemonitoring home blood pressure plus telemonitoring of lifestyle group (TELEM-TELEMEV) will receive both interventions as previously described.
Device: TELEM-TELEMEV
Participants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described.
ACTIVE_COMPARATOR: Usual clinical treatment (UCT)
Participants in the control group will be under antihypertensive treatment, chosen at the discretion of the assistant physician. Participants will not receive any technological tool to stimulate blood pressure control or lifestyle modification.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory blood pressure monitoring (ABPM)
Time Frame: Change at six months (end of the trial)
Reduction in 24h-systolic blood pressure
Change at six months (end of the trial)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Sandra C Fuchs, HCPA, UFRGS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

February 1, 2019

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (ESTIMATE)

December 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 31423214.0.0000.5327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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