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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
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE July 20, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date July 29, 2016
Study Start Date  ICMJE September 2001
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
Patient adherence [ Time Frame: 12 months ]
self-report, Morisky measure
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00123045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
Reduction in systolic blood pressure [ Time Frame: 12 months ]
change in systolic blood pressure from baseline to 12 months of follow-up
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-Physician Partnership to Improve High Blood Pressure Adherence
Official Title  ICMJE Patient-Physician Partnership to Improve High Blood Pressure Adherence
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Hypertension
Intervention  ICMJE Behavioral: health education
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2011)
279
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Physicians - general internists and family physicians who see patients at least 20 hours per week at one of the participating study sites. Physicians are excluded if they intend to leave the practice within 12 months.

Patients - adults aged 18 years and older, with a diagnosis of hypertension (at least one claim with the ICD-9 code 401 in the preceding year), and able to provide contact information for themselves and at least one other person.

Patients who are too acutely ill, disoriented, or unresponsive to complete the baseline assessment and those with medical conditions that might limit their participation in the study (e.g., AIDS/HIV, schizophrenia, cancer (except skin), Alzheimer's or other form of dementia; end-stage renal disease, congestive heart failure, or active tuberculosis) are excluded.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123045
Other Study ID Numbers  ICMJE 232
R01HL069403 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa A Cooper, MD, MPH Johns Hopkins University
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP