Home » Trials » SLCTR/2018/043
A randomized control trial to assess the effectiveness of an information package for improving detection of chronic kidney disease (CKD) by medical officers of Gampaha district
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SLCTR Registration Number
SLCTR/2018/043
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomized control trial to assess the effectiveness of an information package for improving detection of chronic kidney disease (CKD) by medical officers of Gampaha district
Public Title of Trial
A randomized control trial to assess the effectiveness of an information package for improving detection of chronic kidney disease (CKD) by medical officers of Gampaha district
Disease or Health Condition(s) Studied
Chronic Kidney disease
Scientific Acronym
None
Public Acronym
None
Brief title
A RCT using an information package for medical officers to detect CKD in Gampaha district
Universal Trial Number
U1111-1221-4930
Any other number(s) assigned to the trial and issuing authority
P/04/01/2018: ERC Faculty of Medicine, University of Kelaniya
What is the research question being addressed?
How effective is an information package for medical officers, on detecting chronic kidney disease, among patients attending medical clinics in primary and secondary care level hospitals?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Screening
Study Phase
Not Applicable
Intervention(s) planned
Study setting: All primary and secondary care government health institutions in Gampaha district
Randomization: Block randomization.
Number of arms in the study: Study contains two arms, intervention arm and the control arm.
Intervention package consists of
A small summary document regarding primary care management of CKD
Self assessment guide for medical officers regarding process of renal care provision
Summary sheet to be attached to the clinic books
Two eGFR tables.
All the above documents will be provided to medical officers at once as the information package.
Consent will be obtained from eligible medical officers in the Gampaha district.
Those eligible and willing officers will be randomized Those who will belong to the intervention arm will receive the above developed information package Intervention will be implemented only once within two week period to all the officers belong to intervention arm by the PI. PI will only be involved with distribution. Any things like discussing the contents will not be done with the medical officers.
Standard care - The control group have received standard knowledge (MBBS or more), they have received work experience during working in hospitals and clinics , they also receive ongoing in service training or any other management training,circulars ,books ,publications during this period from the health system. Any of those standard things will not be obstructed to control group similar to intervention group.
Blinding - Only outcome assessors will be blinded . Two medical officers will be trained to make outcome assessment. They will provide the scanned copies of clinic books. They will be blinded to the intervention status.
Inclusion criteria
All the medical officers in the Gampaha district conducting family medical clinics and medical clinics conducted by VP OPD and general physicians.
Exclusion criteria
Intern medical offices Medical officers who conduct diabetic clinics or endocrinology clinics headed by consultant endocrinologists , cardiology clinics headed by consultant cardiologists , nephrology clinics headed by consultant nephrologists
Primary outcome(s)
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1.
Primary outcome will be detected /assessed by presence of documentary evidence in clinic books of patients following three months of implementation. Presence of all five steps are expected to present in the clinic book to consider as proper detection of CKD.
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[ Three months after implementation of intervention ] |
Secondary outcome(s)
|
1.
Presence of documenatary evidence for provision of minimum three or more of following evidence based management measures for patients according to their need after the date of intervention will be taken as improved provision of care.
Presence of documentary evidence in the clinic books is expected |
[ Three months after implementation of intervention ] |
Target number/sample size
All medical officers in the Gampaha district conducting medical clinics in primary and secondary care health institutions
Countries of recruitment
Sri Lanka
Anticipated start date
2019-01-01
Anticipated end date
2019-03-20
Date of first enrollment
2019-01-12
Date of study completion
Recruitment status
Complete: follow up continuing
Funding source
Self funded and from MRII
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-11-13
Approval number
P/04/01/2018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Ramya Hettiarachchi
Registrar in Community Medicine
Faculty of Medicine , University of Kelaniya,
Sri Lanka
0777656066
0777656066
ramyasrimathi7@gmail.com
Contact Person for Public Queries
Prof. Chrishantha Abeysena
Professor in Community Medicine
Department of Public Health Faculty of Medicine University of Kelaniya,
Sri Lanka
0777591715
chrishanthaabeysena@yahoo.com
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
