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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
TBC intervention
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Team-based care, Collaboration, Healthcare professionals, Healthcare services

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire VaudoisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TBC intervention

Usual care

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
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)
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)

Full Information

First Posted
July 27, 2015
Last Updated
July 28, 2015
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Applied Sciences of Western Switzerland, Université du Québec à Trois-Rivières, McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT02511093
Brief Title
A Team-Based Care for Hypertension Management (TBC-HTA)
Acronym
TBC-HTA
Official Title
A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Applied Sciences of Western Switzerland, Université du Québec à Trois-Rivières, McGill University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Team-based care, Collaboration, Healthcare professionals, Healthcare services

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TBC intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
TBC intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in daytime ABPM at 6-month between TBC and usual care patients
Description
Difference in daytime ABPM at 6-month between TBC and usual care patients
Time Frame
6-month
Title
Difference in the proportion of patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 6-month between TBC and usual care patients
Description
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
Secondary Outcome Measure Information:
Title
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
Description
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
Time Frame
6-month
Title
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)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Santschi, PhD
Phone
0041 21 641 38 24
Email
v.santschi@ecolelasource.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Burnier, MD
Phone
0041 21 314 11 29
Email
michel.burnier@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Santschi, PhD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Burnier, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Santschi, PhD
Phone
0041 21 641 38 24
Email
v.santschi@ecolelasource.ch
First Name & Middle Initial & Last Name & Degree
Michel Burnier, MD
Phone
0041 21 314 11 29
Email
michel.burnier@chuv.ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
34760950
Citation
Santschi V, Wuerzner G, Pais B, Chiolero A, Schaller P, Cloutier L, Paradis G, Burnier M. Team-Based Care for Improving Hypertension Management: A Pragmatic Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 25;8:760662. doi: 10.3389/fcvm.2021.760662. eCollection 2021.
Results Reference
derived
PubMed Identifier
28109266
Citation
Santschi V, Wuerzner G, Chiolero A, Burnand B, Schaller P, Cloutier L, Paradis G, Burnier M. Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. BMC Cardiovasc Disord. 2017 Jan 21;17(1):39. doi: 10.1186/s12872-017-0472-y.
Results Reference
derived

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

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