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Study on Impact of Patient-Held Guidelines on Blood Pressure

This study has been completed.
Sponsor:
Collaborator:
University of Edinburgh
Information provided by:
Ashgrove Research Practice
ClinicalTrials.gov Identifier:
NCT00148434
First received: September 7, 2005
Last updated: September 26, 2005
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00148434     History of Changes
Other Study ID Numbers: OOB/3/19/F25, OOB/3/19/F25 CSO
Study First Received: September 7, 2005
Last Updated: September 26, 2005
Health Authority: Scotland: Scottish Executive Health Department

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013