NCT00148434

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 27, 2005

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

September 26, 2005

Conditions

Hypertension

Keywords

hypertensionguidelinespatient empowermentanxiety

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with systolic blood pressure <150 and diastolic blood pressure <90

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Patient-held guideline for hypertensionBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients on the hypertension register of the practice

You may not qualify if:

  • Patients unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashgrove Health Centre

Blackburn West Lothian, EH47 7LL, United Kingdom

Location

MeSH Terms

Conditions

HypertensionPatient ParticipationAnxiety Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorMental Disorders

Study Officials

  • Brian McKinstry, MD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

January 1, 2002

Study Completion

March 1, 2003

Last Updated

September 27, 2005

Record last verified: 2005-09

Locations

GB(1)