Home » Trials » SLCTR/2008/010
Development and testing program for opportunistic screening for blood pressure and its management in a district hospital setting using the total risk approach
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SLCTR Registration Number
SLCTR/2008/010
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Development and testing program for opportunistic screening for blood pressure and its management in a district hospital setting using the total risk approach
Public Title of Trial
Development and testing program for opportunistic screening for blood pressure and its management in a district hospital setting using the total risk approach
Disease or Health Condition(s) Studied
Hypertension management
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/06/019 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Feasibility of a opportunistic screening for blood pressure and its management using the total risk approach ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Screening
Study Phase
Not Available
Intervention(s) planned
Selected district hospitals will be randomly allocated to two groups and one will receive training of doctors of opportunistic screening for blood pressure and its management using the total risk approach the control arm - the patients diagnosed with high blood pressure will be management using conventional treatment
Inclusion criteria
Patients above 40 years with high blood pressure
Exclusion criteria
1.Under 40 years of age 2.Refusal of consent
Primary outcome(s)
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1.
•Improvement in the proportion of opportunistic screening for blood pressure of patients above 40 years •absolute reduction of systolic and diastolic pressure |
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Secondary outcome(s)
|
1.
•Proportion of patients with changes in selected risk factors - smoking , body weight, physical activity, "heart healthy" diet •Reduction in risk category |
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Target number/sample size
280
Countries of recruitment
Sri Lanka
Anticipated start date
2007-01-01
Anticipated end date
2008-12-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Epidemiological Unit
Regulatory approvals
Status
Approved
Date of Approval
2006-03-16
Approval number
EC/06/019
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Lakmini Magodaratna
Medical Officer
National Dengue Control Unit, No.5/555, Alvitigala Mawatha, Colombo 05
2368416
0779-664320
2368416
ndcu1@sltnet.lk
Contact Person for Public Queries
Dr. Lakmini Magodaratna
Medical Officer
National Dengue Control Unit, No.5/555, Alvitigala Mawatha, Colombo 05
2368416
0779-664320
2368416
ndcu1@sltnet.lk
Primary study sponsor/organization
Epidemiological Unit
231, De Saram Place, Colombo 8
2681548, 2695112
2696583
chepid@sltnet.lk, epidunit@sltnet.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
