STITCH (Simplified Therapeutic Intervention To Control Hypertension)

University of Western Ontario, Canada

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: fixed dose combination therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00129909

RPO402A RPO402B;

Details and patient eligibility

About

The objective of this study is to assess whether the implementation of a primary treatment algorithm using a fixed dose combination therapy will improve the management of hypertension when compared to usual management.

Full description

There is a clear need for improved approaches for both improved blood pressure control and improved compliance with medication regimens. Although decreasing the frequency of drug taking does improve blood pressure control, whether fixed-dose combinations are more effective than taking multiple tablets is unknown. Additionally, notwithstanding the presence of excellent evidence-based recommendations for the treatment of hypertension, the choices for practitioners in regards to first line therapy is widening (and may be more confusing, especially in the setting of the proliferation of recommendations for a range of diseases). Whether a simplified treatment algorithm, consistent with the Canadian Hypertension Education Program (CHEP) guidelines but using a step-care approach, might improve management of hypertension is unknown. The current study will determine the effectiveness of a simplified treatment algorithm which incorporates early use of a fixed-dose combination therapy.

This is a cluster randomized controlled trial. Approximately 50 family practices eligible for study participation will be randomized in a 1:1 ratio to implement a treatment algorithm or to continue usual care for the management of hypertension. The randomization schedule will be stratified by the year of graduation of the family physician (< 1984 or ≥ 1984). Within each practice, 50 subjects will be managed according to the algorithm or usual care and will be followed for six months.

Enrollment

2,081 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Male or female subjects 18 years or older
Hypertension SBP ≥ 140 mmHg or DBP ≥ 90 mmHg whether untreated or partially treated
Absence of ischemic heart disease, atrial fibrillation, peripheral vascular disease, stroke and chronic kidney disease
Not participating in other hypertension studies
Ability to give informed consent