Blood Pressure, HighPhase 3TIMNCT03005470
Technology for Innovative Monitoring of Cardiovascular Prevention: a RCT
A Phase 3 study testing TELEM, TELEMEV and TELEM-TELEMEV in people with Blood Pressure, High and Prehypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Blood Pressure, High, Prehypertension
- What is being tested?
- TELEM, TELEMEV and TELEM-TELEMEV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to Feb 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Pressure, High, Prehypertension
- Being tested
- TELEM, TELEMEV, TELEM-TELEMEV, UCT
- Keywords
- Prehypertension, Hypertension, Blood pressure, Intervention, Lifestyle, Blood pressure monitoring, Ambulatory Blood Pressure Monitoring, Text Messages, High blood pressure
- Medical subject headings
- Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TELEMDevice
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.
TELEMEVDevice
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-TELEMEVDevice
Participants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described.
UCTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: UCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure monitoring (ABPM)
Reduction in 24h-systolic blood pressure
Measured: Change at six months (end of the trial)
Secondary outcomes (5)
ABPM
Reduction in 24h-diastolic blood pressure
Measured: Change at six months (end of the trial)
Other ABPM measurements
Reduction in daytime and nighttime systolic blood pressure
Measured: Change from baseline to end of the trial
Office blood pressure
Office blood pressure control rate: <130/80 mmHg
Measured: At six months (end of the trial)
Reduction in sodium urinary excretion
Reduction in sodium urinary excretion in a urinary spot
Measured: Change at six months (end of the trial)
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
Measured: Change at six months (end of the trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure, HighStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Sandra Costa Fuchs, Hospital de Clinicas de Porto Alegre
- Investigators
- Sandra C Fuchs, Principal investigator, HCPA, UFRGS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005470
- Sponsor's protocol ID
- CAAE: 31423214.0.0000.5327
- Acronym
- TIM
- Status last verified
- Apr 2018
- First submitted
- 23 Dec 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 37107903Fuchs 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.
PubMed 30087093
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology for Innovative Monitoring of Cardiovascular Prevention: A Precision Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03005470
- Acronym / sponsor ID
- TIM / CAAE: 31423214.0.0000.5327
- Conditions
- Blood Pressure, High, Prehypertension
- Keywords
- Prehypertension, Hypertension, Blood pressure, Intervention, Lifestyle, Blood pressure monitoring, Ambulatory Blood Pressure Monitoring, Text Messages
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Jan 2017
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| TELEM group | Experimental | Device: TELEMParticipants 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. |
| TELEMEV group | Experimental | Device: TELEMEVIn 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. |
| TELEM-TELEMEV group | Experimental | Device: TELEM-TELEMEVParticipants in the telemonitoring home blood pressure plus telemonitoring of lifestyle group (TELEM-TELEMEV) will receive both interventions as previously described. |
| Usual clinical treatment (UCT) | Active comparator | Other: UCTParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TELEMParticipants 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. | Device | TELEM group |
| TELEMEVIn 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. | Device | TELEMEV group |
| TELEM-TELEMEVParticipants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described. | Device | TELEM-TELEMEV group |
| UCTParticipants 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. | Other | Usual clinical treatment (UCT) |
Primary outcome
Ambulatory blood pressure monitoring (ABPM)
Time frame: Change at six months (end of the trial)
Reduction in 24h-systolic blood pressure
5 secondary outcomes
ABPM
Time frame: Change at six months (end of the trial)
Other ABPM measurements
Time frame: Change from baseline to end of the trial
Office blood pressure
Time frame: At six months (end of the trial)
Reduction in sodium urinary excretion
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Derived from this study: PubMed 37107903David 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.
- Derived from this study: PubMed 30087093Fuchs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra C Fuchs principal investigator
HCPA, UFRGS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TELEM, TELEMEV and TELEM-TELEMEV in people with Blood Pressure, High and Prehypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory blood pressure monitoring (ABPM) (time frame: Change at six months (end of the trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005470, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.