Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities
Primary Purpose
Hypertension, Resistant to Conventional Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Health Coaching
Multiprofessional Team
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension, Resistant to Conventional Therapy
Eligibility Criteria
Inclusion Criteria:
- Blood pressure above 160/90mmHg
- Signed the free and informed consent form
- Regularly enrolled, with at least two visits in the last 12 months
Exclusion Criteria:
- Miss the subsequent consultation
- Those who have not signed the free informed consent form.
Sites / Locations
- Universidade Federal de GoiasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Health Coaching
Multiprofessional Team
Arm Description
Individualized follow-up, supporting the individual for a better autonomy in personal care.
Physician, nurse, nutrionist usual care.
Outcomes
Primary Outcome Measures
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.
Lifestyle Changes
Number of patients with grade 2 hypertension who were able to lose weight, adhere to physical exercises, reduce dietary salt.
Treatment Adhesion
Number of patients with grade 2 hypertension who took the drugs according to the medical prescription
Secondary Outcome Measures
Full Information
NCT ID
NCT03046680
First Posted
February 1, 2017
Last Updated
February 5, 2017
Sponsor
Universidade Federal de Goias
1. Study Identification
Unique Protocol Identification Number
NCT03046680
Brief Title
Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities
Official Title
Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
June 1, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Goias
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Resistant to Conventional Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health Coaching
Arm Type
Experimental
Arm Description
Individualized follow-up, supporting the individual for a better autonomy in personal care.
Arm Title
Multiprofessional Team
Arm Type
Active Comparator
Arm Description
Physician, nurse, nutrionist usual care.
Intervention Type
Other
Intervention Name(s)
Health Coaching
Intervention Type
Other
Intervention Name(s)
Multiprofessional Team
Primary Outcome Measure Information:
Title
Number of patients with Grade 2 hypertension achieving blood pressure control (Graded According to NCI CTCAE Version 3.0)
Description
Number of patients with grade 2 hypertension reaching BP <140 / 90mmHg.
Time Frame
6 months
Title
Lifestyle Changes
Description
Number of patients with grade 2 hypertension who were able to lose weight, adhere to physical exercises, reduce dietary salt.
Time Frame
6 months
Title
Treatment Adhesion
Description
Number of patients with grade 2 hypertension who took the drugs according to the medical prescription
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Blood pressure above 160/90mmHg
Signed the free and informed consent form
Regularly enrolled, with at least two visits in the last 12 months
Exclusion Criteria:
Miss the subsequent consultation
Those who have not signed the free informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sayuri Inuzuka
Phone
5562 982157771
Email
sa.inuzuka@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thiago Veiga Jardim
Organizational Affiliation
Universidade Federal de Goias
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal de Goias
City
Goiania
State/Province
GO
ZIP/Postal Code
74015040
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sayuri Inuzuka, Physician
Phone
5562 982157771
Email
sa.inuzuka@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities
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