Condition category
Circulatory System
Date applied
14/08/2007
Date assigned
22/08/2007
Last edited
28/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.york.ac.uk

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

Publication citations

Additional files

Editorial Notes