Hypertension, Resistant to Conventional TherapyNCT03046680
Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities
A study testing Health Coaching and Multiprofessional Team in people with Hypertension, Resistant to Conventional Therapy, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
Hypertension is a multifactorial clinical condition, it may not cause symptoms and its diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage an adequate blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Health Coaching and Multiprofessional Team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2016to 30 Dec 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blood pressure above 160/90mmHg
- Signed the free and informed consent form
- Regularly enrolled, with at least two visits in the last 12 months
Who cannot join
- Miss the subsequent consultation
- Those who have not signed the free informed consent form.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Goias
Goiânia, Goiás, 74015040
Sayuri Inuzuka, Physician, 5562 982157771, sa.inuzuka@gmail.com
About this study
Hypertension is a multifactorial clinical condition, it may not cause symptoms and its diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage an adequate blood pressure.
There are several hypotheses for the non-control of blood pressure, among them the difficulty of lifestyle change, irregular treatment with antihypertensive drugs, non-individualized treatment. Studies haven shown that tools such as multiprofessional team and hypertension leagues are important strategies to obtain a better outcome in the hypertension treatment, but new approaches are still necessary. Health Coaching is an individualized form of follow-up, promoting better adherence, better nutrition, smoking cessation, regular physical exercise and regular use of drugs, thus reducing cardiovascular mortality.
Read the detailed description
Drug adherence and lifestyle changes are tools for chronic disease control. The relationship between nutrients, alcohol intake, and weight change in blood pressure was demonstraded in one study, demonstrating the importance of lifestyle change. Studies have shown that multiprofessional team and hypertension leagues are important strategies to obtain a better outcome, but new approaches to the patient are still necessary. Health coaching is an individualized follow-up, promoting better adherence to the hypertension treatment. Health coaching is a new model based on the support of the individual, for a better autonomy in personal care. The process engages de patient with the conditions of the disease itself by increasing knowledge, skill and confidence so that the patient become informed, active in the participation of its own care. Among health care, training is characterized by the expression. Of concerns, answering questions, providing information on home-based follow-up, and collaborative development of health care plans.
Motivated patients are more likely to treatment adherence and more committed to making lifestyle changes and thus effectively managing their illness.
The research is a randomized clinical trial comparing treatment based on health coaching and the usual treatment based in the treatment of hypertension and comorbidities in uncontrolled hypertensive patients.
- Being tested
- Health Coaching, Multiprofessional Team
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingOther
Multiprofessional TeamOther
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Individualized follow-up, supporting the individual for a better autonomy in personal care. Receives: Other: Health Coaching |
| Multiprofessional Team | Active comparator | Physician, nurse, nutrionist usual care. Receives: Other: Multiprofessional Team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Grade 2 hypertension achieving blood pressure control (Graded According to NCI CTCAE Version 3.0)
Number of patients with grade 2 hypertension reaching BP <140 / 90mmHg.
Measured: 6 months
Lifestyle Changes
Number of patients with grade 2 hypertension who were able to lose weight, adhere to physical exercises, reduce dietary salt.
Measured: 6 months
Treatment Adhesion
Number of patients with grade 2 hypertension who took the drugs according to the medical prescription
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start1 Dec 2016
- Primary completion1 Jun 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayuri Inuzuka, Universidade Federal de Goias
- Investigators
- Thiago Veiga Jardim, Study chair, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046680
- Sponsor's protocol ID
- UFGoias
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities
- ClinicalTrials.gov ID
- NCT03046680
- Acronym / sponsor ID
- UFGoias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 8 Feb 2017 (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.
Hypertension is a multifactorial clinical condition, it may not cause symptoms and its diagnosis is often delayed. And even when it is diagnosed early, some patients cannot manage an adequate blood pressure.
There are several hypotheses for the non-control of blood pressure, among them the difficulty of lifestyle change, irregular treatment with antihypertensive drugs, non-individualized treatment. Studies haven shown that tools such as multiprofessional team and hypertension leagues are important strategies to obtain a better outcome in the hypertension treatment, but new approaches are still necessary. Health Coaching is an individualized form of follow-up, promoting better adherence, better nutrition, smoking cessation, regular physical exercise and regular use of drugs, thus reducing cardiovascular mortality.
Detailed description
Drug adherence and lifestyle changes are tools for chronic disease control. The relationship between nutrients, alcohol intake, and weight change in blood pressure was demonstraded in one study, demonstrating the importance of lifestyle change. Studies have shown that multiprofessional team and hypertension leagues are important strategies to obtain a better outcome, but new approaches to the patient are still necessary. Health coaching is an individualized follow-up, promoting better adherence to the hypertension treatment. Health coaching is a new model based on the support of the individual, for a better autonomy in personal care. The process engages de patient with the conditions of the disease itself by increasing knowledge, skill and confidence so that the patient become informed, active in the participation of its own care. Among health care, training is characterized by the expression. Of concerns, answering questions, providing information on home-based follow-up, and collaborative development of health care plans.
Motivated patients are more likely to treatment adherence and more committed to making lifestyle changes and thus effectively managing their illness.
The research is a randomized clinical trial comparing treatment based on health coaching and the usual treatment based in the treatment of hypertension and comorbidities in uncontrolled hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Other: Health CoachingIndividualized follow-up, supporting the individual for a better autonomy in personal care. |
| Multiprofessional Team | Active comparator | Other: Multiprofessional TeamPhysician, nurse, nutrionist usual care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blood pressure above 160/90mmHg
- Signed the free and informed consent form
- Regularly enrolled, with at least two visits in the last 12 months
Key exclusion criteria (2 listed)
- Miss the subsequent consultation
- Those who have not signed the free informed consent form.
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 |
|---|---|---|
| Health Coaching | Other | Health Coaching |
| Multiprofessional Team | Other | Multiprofessional Team |
Primary outcome
Number of patients with Grade 2 hypertension achieving blood pressure control (Graded According to NCI CTCAE Version 3.0)
Time frame: 6 months
Number of patients with grade 2 hypertension reaching BP <140 / 90mmHg.
Lifestyle Changes
Time frame: 6 months
Number of patients with grade 2 hypertension who were able to lose weight, adhere to physical exercises, reduce dietary salt.
Treatment Adhesion
Time frame: 6 months
Number of patients with grade 2 hypertension who took the drugs according to the medical prescription
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- 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.
Thiago Veiga Jardim study chair
Universidade Federal de Goias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching and Multiprofessional Team in people with Hypertension, Resistant to Conventional Therapy, run by Universidade Federal de Goias 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 3 inclusion and 2 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 8 Feb 2017. 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.
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 Sayuri Inuzuka (5562 982157771, sa.inuzuka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Grade 2 hypertension achieving blood pressure control (Graded According to NCI CTCAE Version 3.0) (time frame: 6 months). The study lists 3 primary outcomes in all. 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 8 Feb 2017.