HypertensionTBC-HTANCT02511093
A Team-Based Care for Hypertension Management (TBC-HTA)
A study testing TBC intervention in people with Hypertension, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- TBC intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
Valerie Santschi, PhD, 0041 21 641 38 24, v.santschi@ecolelasource.ch
Michel Burnier, MD, 0041 21 314 11 29, michel.burnier@chuv.ch
About this study
Official title: A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study
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.
- Conditions
- Hypertension
- Being tested
- TBC intervention
- Keywords
- Hypertension, Team-based care, Collaboration, Healthcare professionals, Healthcare services
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBC interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TBC intervention | Experimental | 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. Receives: Behavioral: TBC intervention |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6-month
Secondary outcomes (2)
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
Measured: 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)
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)
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, Université du Québec à Trois-Rivières, McGill University
- Responsible party
- Principal investigator, Valérie Santschi, Centre Hospitalier Universitaire Vaudois
- Investigators
- Valerie Santschi, PhD, Principal investigator, Centre Hospitalier Universitaire VaudoisMichel Burnier, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511093
- Sponsor's protocol ID
- 449/13
- Acronym
- TBC-HTA
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
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 34760950Santschi 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02511093
- Acronym / sponsor ID
- TBC-HTA / 449/13
- Conditions
- Hypertension
- Keywords
- Hypertension, Team-based care, Collaboration, Healthcare professionals, Healthcare services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, Université du Québec à Trois-Rivières, McGill University
- Study start
- Sep 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBC intervention | Experimental | Behavioral: TBC interventionA 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 intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- unable to understand the study aim;
- pregnancy and lactating;
- livimg in a nursing home;
- hospitalization during the recruitment period;
- participation in another study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBC interventionA 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. | Behavioural | TBC intervention |
Primary outcome
Difference in daytime ABPM at 6-month between TBC and usual care patients
Time frame: 6-month
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
Time frame: 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
2 secondary outcomes
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
Time frame: 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)
Time frame: 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Derived from this study: PubMed 34760950Santschi 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.
- Derived from this study: PubMed 28109266Santschi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Santschi, PhD principal investigator
Centre Hospitalier Universitaire Vaudois
Michel Burnier, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TBC intervention in people with Hypertension, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie Santschi, PhD (0041 21 641 38 24, v.santschi@ecolelasource.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in daytime ABPM at 6-month between TBC and usual care patients (time frame: 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511093, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.