A randomised trial of a brief cognitive-behavioural, manualised, self-management programme for hypertension delivered in a cardiac patient club in Shanghai
| ISRCTN | ISRCTN73114566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73114566 |
| Protocol serial number | N/A |
| Sponsor | University of York |
| Funders | Great Britain-China Educational Trust (UK), Henry Lester Trust Limited (UK) |
- Submission date
- 14/08/2007
- Registration date
- 22/08/2007
- Last edited
- 10/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Feng Xue
Scientific
Scientific
Postgraduate Area
2nd Floor
Hull York Medical School (HYMS) Building
University of York
Heslington
York
YO10 5DD
United Kingdom
| fx101@york.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic randomised controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised trial of a brief cognitive-behavioural, manualised, self-management programme for hypertension delivered in a cardiac patient club in Shanghai |
| Study objectives | 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(s) | The Department of Health, Sciences Research Governance Committee at the University of York approved this study on 5 January 2005. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | Systolic and diastolic blood pressure at 1 month and 4 months after the end of treatment. |
| Key secondary outcome measure(s) | 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 |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 140 |
| Total final enrolment | 140 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
- China
Study participating centre
Postgraduate Area
York
YO10 5DD
United Kingdom
YO10 5DD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/05/2008 | 10/01/2020 | Yes | No |
Editorial Notes
10/01/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
