Protocol summary

Summary
This study aimed at determining which reminding method or recall that is most cost-effective in getting women to do repeat pap smear in a pilot project called the SIPP program (translated as information system of pap smear program) had been introduced whereby women aged 20 years old were invited for pap smear and again invited in the following years to repeat the test if the previous cervical cytology was normal.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013061113632N1
Registration date: 2013-06-18, 1392/03/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-18, 1392/03/28
Registrant information
Name
Rima Marhayu Abdul Rashid
Name of organization / entity
University of Malaya
Country
Malaysia
Phone
0060379674756
Email address
drmarhayu@moh.gov.my
Recruitment status
Recruitment complete
Funding source
This study had received the PPP grant of University Malaya, Kuala Lumpur.
Expected recruitment start date
2011-06-01, 1390/03/11
Expected recruitment end date
2011-07-30, 1390/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
CEA of Different Types of Reminder for Pap Smear Screening
Public title
Call-Recall System for Pap Smear screening in Klang: Patients' Response and Cost Effective Analysis of Different Types of Reminder on the Patients' Response Rates
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: Responded to the first invitation; did not diagnosed of having positive smear; due for next screening according to SIPPS guideline; Malaysian women. Exclusion criteria: Age less than 20 years old; age more than 65 years old; have been diagnosed of having cervical cancer during the last smear.
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 1000
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

1

Registry name
National Medical Research Register
Secondary trial Id
NMRR-10-1111-7315
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
University Malaya Medical Centre
Street address
Faculty of Medicine, University Malaya
City
Kuala Lumpur
Postal code
50603
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
7315

Health conditions studied

1

Description of health condition studied
cervical cancer screening program
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
patients' response
Timepoint
pap smear uptake
Method of measurement
number of patients

Secondary outcomes

1

Description
cost effective analysis
Timepoint
8 weeks
Method of measurement
ratio of number of patientscost:

Intervention groups

1

Description
Letter
Category
Prevention

2

Description
Registered Letter
Category
Prevention

3

Description
Short Messages Service (SMS)
Category
Prevention

4

Description
Phone call
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Klang District Health Office
Full name of responsible person
Dr. Che Azlan
Street address
Blok B, Jalan Langat, Bandar Botanic,
City
Klang

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University Malaya
Full name of responsible person
Associate Professor Maznah Dahlui
Street address
Department of Social Preventive Medicine, Faculty of Medicine, University of Malaya,
City
Kuala Lumpur
Grant name
Grant code / Reference number
PS2010A/256
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Malaya
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ministry of Health Malaysia
Full name of responsible person
Dr. Majdah Mohamed
Position
Principal Assistant Director/MBBS/MPH
Other areas of specialty/work
Street address
Family Health Development Division, Ministry of Health,
City
Putrajaya
Province
Kuala Lumpur
Postal code
62590
Phone
006038883 4046
Fax
Email
drmajdah@moh.gov.my
Web page address
http://fh.moh.gov.my

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Malaya
Full name of responsible person
Associate Professor Maznah Dahlui
Position
Head of Department/MBBS/MPH/PHD
Other areas of specialty/work
Street address
Spcial Preventive Medicine, Faculty of Medicine, University of Malaya,
City
Kuala Lumpur
Province
Wilayah Persekutuan
Postal code
50603
Phone
0060379674756
Fax
60379674975
Email
maznahd@ummc.edu.my
Web page address
http://spm.um.edu.my

Person responsible for updating data

Contact
Name of organization / entity
University Malaya
Full name of responsible person
Rima Marhayu Abdul Rashid
Position
DrPH candidate/MBBS/MPH
Other areas of specialty/work
Street address
Department of Social Preventive Medicine, Fcaulty of Medicine, University of Malaya,
City
Kuala Lumpur
Province
Wilayah Persekutuan
Postal code
50603
Phone
0060360383328
Fax
60379674975
Email
drmarhayu@moh.gov.my
Web page address
http://fh.moh.gov.my

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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