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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension, Resistant to Conventional Therapy
• Intervention / Treatment: Other: Health Coaching; Other: Multiprofessional Team

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sayuri Inuzuka; Phone Number: 5562 982157771; Email: sa.inuzuka@gmail.com

Study Locations

• Brazil
  • GO
    • Goiania, GO, Brazil, 74015040
      • Recruiting
      • Universidade Federal de Goias
      • Contact: Sayuri Inuzuka, Physician; Phone Number: 5562 982157771; Email: sa.inuzuka@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health Coaching; Individualized follow-up, supporting the individual for a better autonomy in personal care.	Other: Health Coaching
Active Comparator: Multiprofessional Team; Physician, nurse, nutrionist usual care.	Other: Multiprofessional Team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade Federal de Goias
• Investigators: Study Chair: Thiago Veiga Jardim, Universidade Federal de Goias

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 30, 2017

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: UFGoias

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No