Patient-Physician Partnership to Improve High Blood Pressure Adherence
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|ClinicalTrials.gov Identifier: NCT00123045|
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : July 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Hypertension||Behavioral: health education||Phase 4|
Hypertension is a common, chronic condition that contributes substantially to cardiovascular morbidity and mortality and resource use. Despite the proven efficacy of pharmacologic therapy and lifestyle modification for treatment of hypertension and prevention of its complications, most adults with established hypertension are uncontrolled. Limited access to medical care and financial barriers to obtaining medications play an important role; however, even among patients who receive regular care, blood pressure control remains suboptimal. Patient non-adherence to recommended therapies and problems in physician management of patients with hypertension are critical contributors to poor quality of care and negative health outcomes of hypertension. Of particular concern is the disproportionately high prevalence and incidence of hypertension and its complications among African Americans and socioeconomically disadvantaged persons. Ethnic and social class disparities in patient adherence are frequently based on financial, logistical, environmental, and cultural barriers that, while not unique to ethnic minorities and the poor, have a greater impact on these populations. Patient and physician interventions were designed to address the specific needs of inner city ethnic minorities and persons living in poverty. The study used a patient-centered, culturally tailored, education and activation intervention with active follow-up delivered by a community health worker in the clinic. It also included a computerized, self-study communication skills training program delivered via an interactive CD-ROM, with tailored feedback to address physicians' individual communication skills needs.
The study used a patient-centered, culturally tailored, education and activation intervention with active follow-up delivered by a community health worker in the clinic. It also included a computerized, self-study communication skills training program delivered via an interactive CD-ROM, with tailored feedback to address physicians' individual communication skills needs. Fifty physicians and 500 of their patients who had uncontrolled hypertension were recruited into a randomized controlled trial with a 2X2 factorial design. The 50 physicians were randomized to receive either a 2-hour CD-ROM based communication skills training or no training. Within each randomized physician, 10 patient-subjects were randomized to either minimal intervention or patient activation (community health worker visit and follow-up calls, plus photo novels and other mailed educational literature). Assessments of primary care appointment keeping, medication possession, medication taking, health status, satisfaction, and numerous other variables were made at baseline, 3 months, and 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||279 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Patient-Physician Partnership to Improve High Blood Pressure Adherence|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
- Patient adherence [ Time Frame: 12 months ]self-report, Morisky measure
- Reduction in systolic blood pressure [ Time Frame: 12 months ]change in systolic blood pressure from baseline to 12 months of follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123045
|Principal Investigator:||Lisa A Cooper, MD, MPH||Johns Hopkins University|