NCT03046680

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

February 1, 2017

Last Update Submit

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

EXPERIMENTAL

Individualized follow-up, supporting the individual for a better autonomy in personal care.

Other: Health Coaching

Multiprofessional Team

ACTIVE COMPARATOR

Physician, nurse, nutrionist usual care.

Other: Multiprofessional Team

Interventions

Health Coaching
Multiprofessional Team

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

  • Thiago Veiga Jardim

    Universidade Federal de Goias

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
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

Locations