Clinical trial NCT03005470: Technology for Innovative Monitoring of Cardiovascular Prevention: a RCT
Official title: Technology for Innovative Monitoring of Cardiovascular Prevention: A Precision Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Blood Pressure, High
Prehypertension
Keywords: Prehypertension
Hypertension
Blood pressure
Intervention
Lifestyle
Blood pressure monitoring
Ambulatory Blood Pressure Monitoring
Text Messages
High blood pressure
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2016-12-29
Enrollment: 231
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory blood pressure monitoring (ABPM)
timeFrame: Change at six months (end of the trial)
Secondary outcomes:
measure: ABPM
timeFrame: Change at six months (end of the trial)
measure: Other ABPM measurements
timeFrame: Change from baseline to end of the trial
measure: Office blood pressure
timeFrame: At six months (end of the trial)
measure: Reduction in sodium urinary excretion
timeFrame: Change at six months (end of the trial)
measure: Improvement of lifestyle: increase of regular physical activity, intake of DASH-type diet, or weight reduction
timeFrame: Change at six months (end of the trial)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: HCPA, UFRGS
name: Sandra C Fuchs
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.