A Team-Based Care for Hypertension Management (TBC-HTA)
TBC-HTA
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Sep 2014
Longer than P75 for not_applicable hypertension
1 active site
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
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 27, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 29, 2015
July 1, 2015
3.8 years
July 27, 2015
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
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 Outcomes (2)
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)
12-month
Study Arms (2)
TBC intervention
EXPERIMENTALA 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.
Usual care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire Vaudoislead
- University of Applied Sciences of Western Switzerlandcollaborator
- Université du Québec à Trois-Rivièrescollaborator
- McGill Universitycollaborator
Study Sites (1)
Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (2)
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.
PMID: 34760950DERIVEDSantschi 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.
PMID: 28109266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie Santschi, PhD
Centre Hospitalier Universitaire Vaudois
- PRINCIPAL INVESTIGATOR
Michel Burnier, MD
Centre Hospitalier Universitaire Vaudois
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Valérie Santschi, PharmDipl, PhD
Study Record Dates
First Submitted
July 27, 2015
First Posted
July 29, 2015
Study Start
September 1, 2014
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
July 29, 2015
Record last verified: 2015-07