Contact information
Type
Scientific
Primary contact
Mr Feng Xue
ORCID ID
Contact details
Postgraduate Area
2nd Floor
Hull York Medical School (HYMS) Building
University of York
Heslington
York
YO10 5DD
United Kingdom
fx101@york.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Patients recruited from an anti-hypertensive club who are shown how to use a cognitive-behavioural self-management manual together with brief group faciliatation, will demonstrate similar levels of blood pressure, self-efficacy, behavioural change and quality of life at follow-ups when compared to patients given written information alone.
Ethics approval
The Department of Health, Sciences Research Governance Committee at the University of York approved this study on 5 January 2005.
Study design
Pragmatic randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hypertension
Intervention
Intervention group: A self-management manual (the Hypertension Manual) plus four educational sessions (in small groups)
Control group: Written information alone
The topics covered in the educational sessions included the following:
1. Basic knowledge of hypertension
2. Goal setting
3. Self-monitoring of blood pressure
4. Physical activity (demonstration of exercises)
5. Dietary advice
6. Calculating BMI
7. Food energy calculation
The booklet provided to the control group covered:
1.Basic knowledge on hypertension, including cardiovascular anatomy, definition and classification of hypertension, and how to measure blood pressure
2. Preventive knowledge on hypertension, including the implications of life style changes and a self-assessment tool for cardiovascular risks
3. Clinical knowledge on hypertension, including symptoms and signs of hypertension, anti-hypertensive medication and compliance with taking drugs
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Systolic and diastolic blood pressure at 1 month and 4 months after the end of treatment.
Secondary outcome measures
The following were assessed at 1 month and 4 months after the end of treatment:
1. Blood total cholesterol
2. Urinary sodium and potassium
3. Body mass index
4. Waist circumference
5. Self-efficacy
6. Physical activity
7. Dietary behaviour
8. Quality of life
Overall trial start date
01/09/2004
Overall trial end date
30/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Clinician diagnosed primary hypertension defined as having systolic Blood Pressure (BP) >140 mmHg or diastolic BP >90 mmHg recorded in their medical records. An age criterion is adopted restricting recruitment to those aged 18 to 69 years because the physical activity questionnaire used is only valid in this range.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Secondary forms of hypertension
2. Target organ damage and/or diabetes
3. Use of weight-loss medications
4. Congestive heart failure
5. Angina
6. Life-threatening co-morbidity (e.g. carcinoma, terminal liver or renal failure)
7. Disability that would prevent participation in a walking exercise regime
8. Inability to read or communicate in Chinese, and/or a history of reduced cognitive ability
Recruitment start date
01/09/2004
Recruitment end date
30/11/2005
Locations
Countries of recruitment
China
Trial participating centre
Postgraduate Area
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
The University of York (UK)
Sponsor details
Heslington
York
YO10 5DD
United Kingdom
jah14@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Great Britain-China Educational Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Henry Lester Trust Limited (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary