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

Study Overview
=================
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.

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

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: TBC intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBC intervention<br>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<br>* 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.<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention | Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention | 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) | 12-month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Team-based care, Collaboration, Healthcare professionals, Healthcare services