Clinical trial NCT02511093: A Team-Based Care for Hypertension Management (TBC-HTA)
Official title: A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Team-based care
Collaboration
Healthcare professionals
Healthcare services
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences of Western Switzerland
name: Université du Québec à Trois-Rivières
name: McGill University
First posted: 2015-07-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Difference in daytime ABPM at 6-month between TBC and usual care patients
timeFrame: 6-month
measure: Difference in the proportion of patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 6-month between TBC and usual care patients
timeFrame: 6-month
Secondary outcomes:
measure: Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
timeFrame: 6-month
measure: 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)
timeFrame: 12-month
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Valerie Santschi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Vaudois
name: Michel Burnier, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.