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

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ClinicalTrials.gov Identifier: NCT02511093
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : July 29, 2015
Sponsor:
Collaborators:
University of Applied Sciences of Western Switzerland
Université du Québec à Trois-Rivières
McGill University
Information provided by (Responsible Party):
Valérie Santschi, Centre Hospitalier Universitaire Vaudois

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: TBC intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study
Study Start Date : September 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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.

No Intervention: Usual care



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511093


Contacts
Contact: Valerie Santschi, PhD 0041 21 641 38 24 v.santschi@ecolelasource.ch
Contact: Michel Burnier, MD 0041 21 314 11 29 michel.burnier@chuv.ch

Locations
Switzerland
Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Valerie Santschi, PhD    0041 21 641 38 24    v.santschi@ecolelasource.ch   
Contact: Michel Burnier, MD    0041 21 314 11 29    michel.burnier@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University of Applied Sciences of Western Switzerland
Université du Québec à Trois-Rivières
McGill University
Investigators
Principal Investigator: Valerie Santschi, PhD Centre Hospitalier Universitaire Vaudois
Principal Investigator: Michel Burnier, MD Centre Hospitalier Universitaire Vaudois

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valérie Santschi, Dr. Valérie Santschi, PharmDipl, PhD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02511093     History of Changes
Other Study ID Numbers: 449/13
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Valérie Santschi, Centre Hospitalier Universitaire Vaudois:
Hypertension
Team-based care
Collaboration
Healthcare professionals
Healthcare services

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases