Viewing Study NCT00123045



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Study NCT ID: NCT00123045
Status: COMPLETED
Last Update Posted: 2016-07-29
First Post: 2005-07-20

Brief Title: Patient-Physician Partnership to Improve High Blood Pressure Adherence
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Heart Lung and Blood Institute NHLBI

Study Overview

Official Title: Patient-Physician Partnership to Improve High Blood Pressure Adherence
Status: COMPLETED
Status Verified Date: 2011-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To test the efficacy of a patient-centered culturally tailored education and activation intervention designed to improve adherence to medication and life style recommendations among adults with uncontrolled hypertension
Detailed Description: BACKGROUND

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

DESIGN NARRATIVE

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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL069403 NIH None httpsreporternihgovquickSearchR01HL069403