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
Secondary identifying numbers RPC050
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

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Email mendiss@who.int

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHypertension
Intervention20 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date07/05/2004
Completion date07/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteria1. 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 enrolment07/05/2004
Date of final enrolment07/05/2005

Locations

Countries of recruitment

  • Sri Lanka
  • Switzerland

Study participating centre

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor information

The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)
Research organisation

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Website http://www.who.int
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan