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

NCT ID: NCT02511093

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TBC intervention

Intervention Type BEHAVIORAL

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.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Applied Sciences of Western Switzerland

OTHER

Sponsor Role collaborator

Université du Québec à Trois-Rivières

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Valérie Santschi

Dr. Valérie Santschi, PharmDipl, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valerie Santschi, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Michel Burnier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

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Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Valerie Santschi, PhD

Role: CONTACT

0041 21 641 38 24

Michel Burnier, MD

Role: CONTACT

0041 21 314 11 29

Facility Contacts

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Valerie Santschi, PhD

Role: primary

0041 21 641 38 24

Michel Burnier, MD

Role: backup

0041 21 314 11 29

References

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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.

Reference Type DERIVED
PMID: 34760950 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28109266 (View on PubMed)

Other Identifiers

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449/13

Identifier Type: -

Identifier Source: org_study_id

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