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Nurse Administered Intervention to Improve Blood Pressure Control

This study has been completed.

Sponsors and Collaborators: Duke University
Pfizer
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00129103
  Purpose

The goal of this randomized controlled trial is to tailor a health communication intervention to improve functionally health illiterate (FHI) patients' management of their hypertension and to evaluate the impact of this intervention on health outcomes. The investigators expect the intervention will improve FHI patients' management of their hypertension and the study will demonstrate an effective and cost-efficient method for clearly conveying health information to FHI adults.


Condition Intervention
Hypertension
Cardiovascular Diseases
Heart Diseases
Behavioral: Telephone Behavioral Education

MedlinePlus related topics:   Heart Diseases    High Blood Pressure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Health Services Research, Randomized, Open Label, Factorial Assignment, Efficacy Study
Official Title:   Nurse Administered, Tailored, Self-Management Intervention to Improve Blood Pressure Control Among Functionally Illiterate Adults

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Blood pressure (BP) control, systolic blood pressure (SBP)/diastolic blood pressure (DBP) measured at primary care provider (PCP) visits [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Satisfaction with care [ Time Frame: 6 and 12 months ]
  • Efficacy with treatment [ Time Frame: 6 and 12 months ]
  • Risk associated with hypertension [ Time Frame: 6 and 12 months ]
  • Self reported adherence [ Time Frame: 6 and 12 months ]

Enrollment:   174
Study Start Date:   July 2004
Study Completion Date:   June 2007

Arms Assigned Interventions
Intervention: Experimental
Nurse-administered tailored behavioral intervention via telephone
Behavioral: Telephone Behavioral Education
Nursed administered phone calls every 8 weeks.
Usual Care: No Intervention
No nurse-administered behavioral intervention

Detailed Description:

The proposed research will develop a cost-effective, health communication intervention specifically for the purpose of improving BP control among patients with low levels of functional health literacy. Its objectives are:

  • To enroll 250 FHI, hypertensive individuals from primary care clinics into the randomized controlled study;
  • To implement a health communication intervention in which a nurse delivers personally tailored information about BP management over the phone to the patient, using standardized scripts and complementing the phone intervention with visual aids and support of a family member or friend;
  • To evaluate the effectiveness of the intervention on a primary clinical outcome measure -- blood pressure control;
  • To evaluate the intervention's effect on secondary outcome measures -- changes in hypertension risk perception, satisfaction with care, patient confidence following recommended regimen, and self-reported adherence to recommended regimens.

We expect to demonstrate improved health outcomes, measured by BP control (<140/90 mm/Hg), as a result of the intervention. If successful, our intervention will constitute an important health communication tool specifically designed to improve BP control of patients with low health literacy.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • >= 1 International Classification of Diseases, 9th Revision (ICD9) Diagnosis 401.0, 401.1, 401.9
  • Designated primary care provider
  • 1 primary care visit between 4/03 and 4/04
  • Live in 8 county area in North Carolina (NC)
  • >= 1 BP medication

Exclusion Criteria:

  • Dialysis patient
  • Hospitalization for stroke in prior 3 months
  • Myocardial infarction in prior 3 months
  • Coronary artery revascularization in prior 3 months
  • Metastatic cancer diagnosis in prior 3 months
  • Transplant of: kidney; liver; lung; pancreas; peripheral stem cells; bone; bone marrow; heart; intestine; stem cells; tissue (unspecified organ or tissue; V42.9); complications of transplants
  • Nursing home resident
  • Documented diagnosis of dementia
  • Difficulty hearing on telephone
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129103

Locations
United States, North Carolina
Duke University Medical Center Primary Care Clinics    
      Durham, North Carolina, United States, 27705

Sponsors and Collaborators
Duke University
Pfizer

Investigators
Principal Investigator:     Hayden B Bosworth, PhD     Duke University Medical Center and Durham Veterans Affairs Medical Center    
  More Information


Study ID Numbers:   SPS125874
First Received:   August 10, 2005
Last Updated:   November 21, 2007
ClinicalTrials.gov Identifier:   NCT00129103
Health Authority:   United States: Institutional Review Board

Keywords provided by Duke University:
Hypertension  
Cardiovascular Diseases  
Health Illiteracy  

Study placed in the following topic categories:
Heart Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008




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