Evaluation of World Health Organisation (WHO) cardiovascular disease (CVD)-risk management package - scenario one (Sri Lanka)
| ISRCTN | ISRCTN48141450 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48141450 |
| Protocol serial number | RPC050 |
| Sponsor | The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland) |
| Funder | The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland) |
- Submission date
- 06/04/2005
- Registration date
- 07/06/2005
- Last edited
- 26/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Mendis
Scientific
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| mendiss@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | 20 primary health care facilities. 10 facilities to apply the study protocol based on Scenario One of the WHO CVD-Risk Management Package (intervention sites). Other 10 to continue with conventional treatment or usual care (control sites). |
| Intervention type | Other |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 07/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | 1. Age 30 - 70 years 2. Currently not under treatment for hypertension 3. Systolic blood pressure between 140 and 179 mmHg measured twice with a 5 to 10 minute interval 4. Informed consent given |
| Key exclusion criteria | 1. Pregnancy 2. Trauma (injury) as presenting complaint 3. Renal diseases: nephropathy, renal artery stenosis 4. Endocrinological (hormonal) disorders: phaechromocytoma, Cushing syndrome, Conn syndrome, acromegaly 5. Coarctation of the aorta 6. Use of steroids and/or non-steroidal anti-inflammatories (NSAIs) 7. All acute conditions presenting with bleeding, pain, diarrhoea, vomiting, breathing disorders and circulatory disorders 8. Inability to comply with the follow-up requirements 9. Inability to provide informed consent |
| Date of first enrolment | 07/05/2004 |
| Date of final enrolment | 07/05/2005 |
Locations
Countries of recruitment
- Sri Lanka
- Switzerland
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
