Technology for Innovative Monitoring of Cardiovascular Prevention: a RCT

NCT03005470 | Unknown Phase 3 DMC

• 1 other identifier: CAAE: 31423214.0.0000.5327
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure, High; Prehypertension

Keywords

Prehypertension; Hypertension; Blood pressure; Intervention; Lifestyle; Blood pressure monitoring; Ambulatory Blood Pressure Monitoring; Text Messages; High blood pressure

Outcome Measures

Primary Outcomes (1)

• Ambulatory blood pressure monitoring (ABPM)

  Reduction in 24h-systolic blood pressure

  Change at six months (end of the trial)

Secondary Outcomes (5)

• ABPM

  Change at six months (end of the trial)

• Other ABPM measurements

  Change from baseline to end of the trial

• Office blood pressure

  At six months (end of the trial)

• Reduction in sodium urinary excretion

  Change at six months (end of the trial)

• Improvement of lifestyle: increase of regular physical activity, intake of DASH-type diet, or weight reduction

  Change at six months (end of the trial)

Study Arms (4)

TELEM group

EXPERIMENTAL

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

TELEMEV group

EXPERIMENTAL

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

TELEM-TELEMEV group

EXPERIMENTAL

Participants in the telemonitoring home blood pressure plus telemonitoring of lifestyle group (TELEM-TELEMEV) will receive both interventions as previously described.

Device: TELEM-TELEMEV

Usual clinical treatment (UCT)

ACTIVE COMPARATOR

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

Interventions

TELEM DEVICE

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.

TELEM group

TELEMEV DEVICE

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.

TELEMEV group

TELEM-TELEMEV DEVICE

Participants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described.

TELEM-TELEMEV group

UCT OTHER

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.

Usual clinical treatment (UCT)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (2)

• David CN, Iochpe C, Harzheim E, Sesin GP, Goncalves MR, Moreira LB, Fuchs FD, Fuchs SC. Effect of Mobile Health Interventions on Lifestyle and Anthropometric Characteristics of Uncontrolled Hypertensive Participants: Secondary Analyses of a Randomized Controlled Trial. Healthcare (Basel). 2023 Apr 8;11(8):1069. doi: 10.3390/healthcare11081069.

  PMID: 37107903 DERIVED

• Fuchs SC, Harzheim E, Iochpe C, David CN, Goncalves MR, Sesin GP, Costa CM, Moreira LB, Fuchs FD. Technologies for Innovative Monitoring to Reduce Blood Pressure and Change Lifestyle Using Mobile Phones in Adult and Elderly Populations (TIM Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 7;7(8):e169. doi: 10.2196/resprot.9619.

  PMID: 30087093 DERIVED

MeSH Terms

Conditions

Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sandra C Fuchs

  HCPA, UFRGS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants have uncontrolled hypertension under on pharmacological treatment. They will be requested not to change drugs and medicine doses during the trial.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sandra C. Fuchs, MD, PhD

Model Details: This is a factorial randomized controlled trial (Figure 1) of effectiveness of the use of technologies - smartphones and blood pressure monitoring - to reduce systolic blood pressure and change lifestyle.

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

BR (1)