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

Hypertension Clinical Trial

— TBC-HTA  

Official title:

A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02511093
• Other study ID #: 449/13
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2015
• Last updated: July 28, 2015
• Start date: September 2014
• Est. completion date: December 2018

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Valerie Santschi, PhD
• Phone: 0041 21 641 38 24
• Email: v.santschi[@]ecolelasource.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Switzerland	Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (4)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois	McGill University, Université du Québec à Trois-Rivières, University of Applied Sciences of Western Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention	Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention	6-month	No
Secondary	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)	12-month	No