Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

Health Coaching Based Treatment Versus Usual Treatment of Systemic Arterial Hypertension and Comorbidities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03046680
• Other study ID #: UFGoias
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2017
• Last updated: February 5, 2017
• Start date: December 1, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: February 2017
• Source: Universidade Federal de Goias
• Contact: Sayuri Inuzuka
• Phone: 5562 982157771
• Email: sa.inuzuka[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Other:
• Health Coaching

• Multiprofessional Team

Locations

Country	Name	City	State
Brazil	Universidade Federal de Goias	Goiania	GO

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Goias

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lifestyle Changes	Number of patients with grade 2 hypertension who were able to lose weight, adhere to physical exercises, reduce dietary salt.	6 months
Primary	Treatment Adhesion	Number of patients with grade 2 hypertension who took the drugs according to the medical prescription	6 months