Study on Impact of Patient-Held Guidelines on Blood Pressure

This study has been completed.
University of Edinburgh
Information provided by:
Ashgrove Research Practice Identifier:
First received: September 7, 2005
Last updated: September 26, 2005
Last verified: September 2005
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
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:

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


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients on the hypertension register of the practice

Exclusion Criteria:

  • Patients unable to consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00148434

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

No publications provided 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:
patient empowerment
anxiety processed this record on November 27, 2015