A Team-Based Care for Hypertension Management (TBC-HTA) (TBC-HTA)

July 28, 2015 updated by: Valérie Santschi, Centre Hospitalier Universitaire Vaudois

A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study

The purpose of this study is to determine whether a team-based care (TBC) intervention, combining physician, nurse and pharmacist care improves BP control compared to usual care at 6 months among outpatients with uncontrolled hypertension.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • treated patients with uncontrolled hypertension (defined as daytime systolic/diastolic ambulatory blood pressure monitoring (ABPM) ≥135/85mmHg) taking one or two antihypertensive medications;
  • speak and understand French;
  • agree to use the same pharmacy's services for the whole duration of the study.

Exclusion Criteria:

  • unable to understand the study aim;
  • pregnancy and lactating;
  • livimg in a nursing home;
  • hospitalization during the recruitment period;
  • participation in another study;
  • daytime ABPM>180/110 mmHg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: TBC intervention

A structured collaborative intervention delivered by trained nurses of ambulatory clinics and by community pharmacists working in collaboration with physicians during 6-month of follow-up includes:

  • BP measurements;
  • an educational and counselling intervention on patient adherence;
  • an educational and counselling intervention on lifestyle (physical activity and diet).

Physicians adjust antihypertensive medications based on nurse and pharmacist feedback.
Behavioral: TBC intervention

A structured collaborative intervention delivered by trained nurses of ambulatory clinics and by community pharmacists working in collaboration with physicians during 6-month of follow-up includes:

  • BP measurements;
  • an educational and counselling intervention on patient adherence;
  • an educational and counselling intervention on lifestyle (physical activity and diet) Physicians adjust antihypertensive medications based on nurse and pharmacist feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in daytime ABPM at 6-month between TBC and usual care patients
Time Frame: 6-month
Difference in daytime ABPM at 6-month between TBC and usual care patients
6-month
Difference in the proportion of patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 6-month between TBC and usual care patients
Time Frame: 6-month
Difference in the proportion of patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 6-month between TBC and usual care patients
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
Time Frame: 6-month
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
6-month
Difference in the proportion of TBC and usual care patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 12-month (6 months after intervention stopped)
Time Frame: 12-month
Difference in the proportion of TBC and usual care patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 12-month (6 months after intervention stopped)
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

McGill University
Université du Québec à Trois-Rivières
University of Applied Sciences of Western Switzerland

Investigators

  • Principal Investigator: Michel Burnier, MD, Centre Hospitalier Universitaire Vaudois
  • Principal Investigator: Valerie Santschi, PhD, Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 449/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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