Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities
1 other identifier
interventional
150
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedFebruary 8, 2017
February 1, 2017
6 months
February 1, 2017
February 5, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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.
6 months
Lifestyle Changes
Number of patients with grade 2 hypertension who were able to lose weight, adhere to physical exercises, reduce dietary salt.
6 months
Treatment Adhesion
Number of patients with grade 2 hypertension who took the drugs according to the medical prescription
6 months
Study Arms (2)
Health Coaching
EXPERIMENTALIndividualized follow-up, supporting the individual for a better autonomy in personal care.
Multiprofessional Team
ACTIVE COMPARATORPhysician, nurse, nutrionist usual care.
Interventions
Eligibility Criteria
You may qualify if:
- Blood pressure above 160/90mmHg
- Signed the free and informed consent form
- Regularly enrolled, with at least two visits in the last 12 months
You may not qualify if:
- Miss the subsequent consultation
- Those who have not signed the free informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Goias
Goiânia, Goiás, 74015040, Brazil
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Thiago Veiga Jardim
Universidade Federal de Goias
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist
Study Record Dates
First Submitted
February 1, 2017
First Posted
February 8, 2017
Study Start
December 1, 2016
Primary Completion
June 1, 2017
Study Completion
December 30, 2017
Last Updated
February 8, 2017
Record last verified: 2017-02