STITCH (Simplified Therapeutic Intervention To Control Hypertension)

• ClinicalTrials.gov Identifier: NCT00129909
• Recruitment Status: Completed
• First Posted: August 12, 2005
• Last Update Posted: June 14, 2012
• Sponsor: University of Western Ontario, Canada
• Collaborator: Pfizer
• Information provided by (Responsible Party): University of Western Ontario, Canada

Tracking Information

• First Submitted Date: August 10, 2005
• First Posted Date: August 12, 2005
• Last Update Posted Date: June 14, 2012
• Study Start Date: May 2005
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 26, 2005): The primary measure of outcome is the proportion of subjects treated to target (systolic blood pressure [SBP] <140 mmHg and diastolic blood pressure [DBP] <90 mmHg) at 6 months, compared at the practice level.
• Original Primary Outcome Measures (submitted: August 10, 2005): The primary measure of outcome is the proportion of subjects treated to target (SBP <140 mmHg and DBP <90 mmHg) at 6 months, compared at the practice level.

Current Secondary Outcome Measures (submitted: September 26, 2005)

• Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level
• Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.

Original Secondary Outcome Measures (submitted: August 10, 2005)

• Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level.
• Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: STITCH (Simplified Therapeutic Intervention To Control Hypertension)
• Official Title: Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms
• Brief Summary: 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension
• Intervention: Drug: fixed dose combination therapy
• Study Arms: Not Provided

Publications *

• Kirkland SA, MacLean DR, Langille DB, Joffres MR, MacPherson KM, Andreou P. Knowledge and awareness of risk factors for cardiovascular disease among Canadians 55 to 74 years of age: results from the Canadian Heart Health Surveys, 1986-1992. CMAJ. 1999;161(8 Suppl):S10-6.
• Berlowitz DR, Ash AS, Hickey EC, Friedman RH, Glickman M, Kader B, Moskowitz MA. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998 Dec 31;339(27):1957-63.
• Khan NA, McAlister FA, Campbell NR, Feldman RD, Rabkin S, Mahon J, Lewanczuk R, Zarnke KB, Hemmelgarn B, Lebel M, Levine M, Herbert C; Canadian Hypertension Education Program. The 2004 Canadian recommendations for the management of hypertension: Part II--Therapy. Can J Cardiol. 2004 Jan;20(1):41-54.
• ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97. Erratum in: JAMA 2003 Jan 8;289(2):178. JAMA. 2004 May 12;291(18):2196.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 13, 2007): 2081
• Original Enrollment (submitted: August 10, 2005): 2500
• Actual Study Completion Date: January 2007
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00129909
• Other Study ID Numbers: RPO402A; RPO402B
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Western Ontario, Canada
• Study Sponsor: University of Western Ontario, Canada
• Collaborators: Pfizer

Investigators

• Study Director: Ross D Feldman, MD; University of Western Ontario, Canada

• PRS Account: University of Western Ontario, Canada
• Verification Date: June 2012