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Study on Impact of Patient-Held Guidelines on Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148434
First Posted: September 8, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Edinburgh
Information provided by:
Ashgrove Research Practice
  Purpose
While patient held guidelines for the management of chronic diseases have been employed in some countries. There is little evidence of their effectiveness in improving patient outcomes. We hypothesised that a patient held guideline on the management of hypertension combined with a specific exhortation to patients to challenge their medical care where the guidelines did not appear to have been applied would improve blood pressure control, lower average blood pressure, lower average cholesterol, increase the appropriate use of statins and aspirin, and have no impact on patient anxiety. Patients were randomised to the guideline or to standard hypertension information. Measures of anxiety were taken at baseline 2 weeks and one year, blood pressure and cholesterol was measured at one year and case notes examined to determine appropriate statin and aspirin usage.

Condition Intervention Phase
Hypertension Behavioral: Patient-held guideline for hypertension Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: A Pilot Randomised Controlled Trial to Assess the Impact on Blood Pressure Control of Empowering Patients to Become Involved in Their Own Blood Pressure Management.

Further study details as provided by Ashgrove Research Practice:

Primary Outcome Measures:
  • Proportion of patients with systolic blood pressure <150 and diastolic blood pressure <90

Secondary Outcome Measures:
  • Average systolic blood pressure
  • Average cholesterol
  • Proportion of patients with cholesterol < 5.0mmol/l
  • Hospital Anxiety and Depression Score
  • Proportion with appropriate use of aspirin and statins according to UK guideline
  • Satisfaction with care
  • Perception of involvement with decision making

Estimated Enrollment: 300
Study Start Date: January 2002
Estimated Study Completion Date: March 2003
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients on the hypertension register of the practice

Exclusion Criteria:

  • Patients unable to consent
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00148434


Locations
United Kingdom
Ashgrove Health Centre
Blackburn West Lothian, United Kingdom, EH47 7LL
Sponsors and Collaborators
Ashgrove Research Practice
University of Edinburgh
Investigators
Principal Investigator: Brian McKinstry, MD University of Edinburgh
  More Information

ClinicalTrials.gov Identifier: NCT00148434     History of Changes
Other Study ID Numbers: OOB/3/19/F25
OOB/3/19/F25 CSO
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Ashgrove Research Practice:
hypertension
guidelines
patient empowerment
anxiety

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases