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Status unknownNCT02511093TBC-HTAUpdated Jul 29, 2015

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

An interventional study of TBC intervention in Hypertension, sponsored by Centre Hospitalier Universitaire Vaudois. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-29.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • Team-based care
  • Collaboration
  • Healthcare professionals
  • Healthcare services
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's planned enrollment of 110 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • 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

  • No intervention
    Usual care

Interventions

  • BehavioralTBC 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6-month

  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

    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 outcomes

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

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

    Time frame: 6-month

  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)

    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

07

Study locations

1 of 1 sites recruiting
  • Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois
    Lausanne, Vaud 1011, Switzerland
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34760950 ↗
  • 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. PubMed 28109266 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02511093
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
University of Applied Sciences of Western Switzerland, Université du Québec à Trois-Rivières, McGill University
Responsible party
Valérie Santschi (Dr. Valérie Santschi, PharmDipl, PhD, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Jul 29, 2015
Start date
Sep 2014
Primary completion
Jun 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jul 29, 2015

Study contacts

Valerie Santschi, PhD
Contact
v.santschi@ecolelasource.ch
0041 21 641 38 24
Michel Burnier, MD
Contact
michel.burnier@chuv.ch
0041 21 314 11 29
Valerie Santschi, PhD
principal investigator · Centre Hospitalier Universitaire Vaudois
Michel Burnier, MD
principal investigator · Centre Hospitalier Universitaire Vaudois

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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