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

31 Dec 2018

The date of last modification

Dec 31, 2018



Application Summary


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


Trial Details


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


Control

Standard therapy


Assignment

Parallel


Purpose

Screening


Phase


Intervention(s) planned

Study setting - All primary and secondary care government health institutions in Gampaha district

Randomization - Block randomization. Detailed account of block randomization technique with a flow chart is attached in annexe ii

Number of arms in the study Study contains two arms, intervention arm and the control arm.

Intervention package consists of

  1. A small summary document regarding primary care management of CKD

  2. Self assessment guide for medical officers regarding process of renal care provision

  3. Summary sheet to be attached to the clinic books

  4. 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)

  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 1.Presence of documentary evidence of ordering of serum creatinine and proteinuria (either UFR , ACR, UPCR) or using an available serum creatinine value done within past nine months duration. 2.Conversion of serum creatinine into eGFR using a formula with the help of a given table ,APP (computer soft wear) , calculation by themselves ) or using laborotory reported values 3.Staging of CKD according to eGFR category(interpretation of eGFR) ,If there is a impairment in eGFR , planning to repeat the eGFR in 3 months . 4. Interpretation of proteinuria value and planning to repeat the test in three months 5.Documentation of renal function status as no renal impairment or stage of CKD if there is renal impairment according to eGFR category or proteinuria category or both .

    [

    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 1.Addition of ARB or ACEI if not added 2. Addition of a statin if not added 3. Ordering a Lipid profile if not done for the fast one year 4. If LDL is > 100 mg /dl , reporting it as high and giving nutritional and exercise counselling. 5. Measuring blood pressure and documentation as high (if BP > 140/90 ) for the disease status and giving nutritional and exercise counseling 6. If there is poor glycemic control adjustment of drugs ( addition of a new drug or increasing the dosage ) or giving dietary counseling 7. Referral to a nutritionist if necessary 8. If smoking is present ,mentioning it as a smoking positive and giving counseling for no smoking 9. Writing a referral to the nephrologist following renal status assessment if needed.

    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


Date of study completion


Recruitment status

Pending


Funding source

self funded and from MRII



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.Ramya Hettiarachchi
Registrar in Community Medicine
Faculty of medicine , University of Kelaniya
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
0777591715


chrishanthaabeysena@yahoo.com


Primary study sponsor/organization

Department of Public Health Faculty of Medicine University of Kelaniya


0112961140 / Ext. 140


Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results