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

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Unknown status

CT.gov ID

NCT02511093

Collaborator

University of Applied Sciences of Western Switzerland (Other), Université du Québec à Trois-Rivières (Other), McGill University (Other)

110

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: TBC intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 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.
No Intervention: Usual care

Arm

Intervention/Treatment

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

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.

No Intervention: Usual care

Outcome Measures

Primary Outcome Measures

Difference in daytime ABPM at 6-month between TBC and usual care patients [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 [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

Secondary Outcome Measures

Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention [6-month]
Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention
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]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

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

Investigators

Principal Investigator: Valerie Santschi, PhD, Centre Hospitalier Universitaire Vaudois
Principal Investigator: Michel Burnier, MD, Centre Hospitalier Universitaire Vaudois