Blood PressureNCT04475367
Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory
A study testing App hypercross group and without App hypercross group in people with Blood Pressure and Adhesion, run by Instituto de Cardiologia do Rio Grande do Sul.
Trial summary
Brief Summary: Through the App, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Blood Pressure, Adhesion
- What is being tested?
- App hypercross group and without App hypercross group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2020to 30 Dec 2021
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia
- older 18 years
Who cannot join
- Patients without a mobile phone compatible with the App
Trial locations and contacts
No sites are listed yet.
About this study
Brief Summary: Through the App, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension.
Read the detailed description
To evaluate treatment adherence and blood pressure reduction, through the HiperCross App, between two groups of hypertensive patients in a Hypertension Public Ambulatory in Porto Alegre.
The investigators hope to identify better adherence to treatment, as well as a significant reduction in blood pressure, all of these results will be better evaluated using the HiperCross application.
- Conditions
- Blood Pressure, Adhesion
- Being tested
- App hypercross group, without App hypercross group
- Keywords
- software, hypertension, technology
- Medical subject headings
- Tissue Adhesions, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App hypercross groupOther
hypertensive patients using HyperCrossApp
without App hypercross groupOther
Interdisciplinary health care
| Study group | Role | What they receive |
|---|---|---|
| hypertensive patients using HyperCrossApp | Experimental | Interdisciplinary health care
+ HyperCross App Receives: Other: App hypercross group |
| hypertensive patients without using HyperCrossApp | Active comparator | Interdisciplinary health care Receives: Other: without App hypercross group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure value
systolic Blood pressure and dyastolic Blood pressure
Measured: 15 minutes
Secondary outcomes (1)
Morisky scale
Medication adherence. The Morisky scale condition and medication specific assessment: 1) measures the level of adherence an medication, 2) measures the severity of Major Depressive Disorder, a determinant of non-adherence 3) identifies why the patient is not taking their medication, 4) determines the risk between non-adherence to BP measures of disease control. 0-1 = Low motivation; 2-3 = High motivation / 0-1 = Low knowledge; 2-3 = High knowledge
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start10 Jul 2020 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be randomized into 2 intervention groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Reis, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Bruna Eibel, PhD, Study director, Post Graduation professor - Cardiology Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475367
- Sponsor's protocol ID
- 5701-19
- Status last verified
- Jul 2020
- First submitted
- 29 May 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory
- ClinicalTrials.gov ID
- NCT04475367
- Acronym / sponsor ID
- 5701-19
- Conditions
- Blood Pressure, Adhesion
- Keywords
- software, hypertension, technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 10 Jul 2020 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 Jul 2020 (actual)
- 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.
Brief Summary: Through the App, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension.
Detailed description
To evaluate treatment adherence and blood pressure reduction, through the HiperCross App, between two groups of hypertensive patients in a Hypertension Public Ambulatory in Porto Alegre.
The investigators hope to identify better adherence to treatment, as well as a significant reduction in blood pressure, all of these results will be better evaluated using the HiperCross application.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomized into 2 intervention groups
| Arm | Type | Receives |
|---|---|---|
| hypertensive patients using HyperCrossApp | Experimental | Other: App hypercross groupInterdisciplinary health care + HyperCross App |
| hypertensive patients without using HyperCrossApp | Active comparator | Other: without App hypercross groupInterdisciplinary health care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia
- older 18 years
Key exclusion criteria (1 listed)
- Patients without a mobile phone compatible with the App
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 |
|---|---|---|
| App hypercross grouphypertensive patients using HyperCrossApp | Other | hypertensive patients using HyperCrossApp |
| without App hypercross groupInterdisciplinary health care | Other | hypertensive patients without using HyperCrossApp |
Primary outcome
Blood pressure value
Time frame: 15 minutes
systolic Blood pressure and dyastolic Blood pressure
1 secondary outcome
Morisky scale
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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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.
Bruna Eibel, PhD study director
Post Graduation professor - Cardiology Foundation
Questions about this trial
What is this clinical trial studying?
A study testing App hypercross group and without App hypercross group in people with Blood Pressure and Adhesion, run by Instituto de Cardiologia do Rio Grande do Sul.
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 2 inclusion and 1 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Ana Paula Reis, Nurse (+555132303600, areis9874@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure value (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2020.