Protocol summary

Summary
The main purpose of this study is to compare the effects of SMS and face to face training on screening tests in middle-aged women. This study follows an accidental approach in which no blinding occurs. No placebo control is involved either. The study focuses on multiple variables. The main criteria for the participants' inclusion and exclusion are as follow: forty to sixty year old women, having a mobile phone, and the eligibility for gynecologic exams, Pap smears, blood biochemical tests (lipid profile, blood glucose, hemoglobin, hematocrit). They will be the included in the study following the aforementioned routines. If one is suffering from a mental disease or any other chronic disease or does not participate in 2 training sessions will be excluded. 90 middle - aged women from Ahvaz are included. Treatments and study time: Samples fall in to two groups .i.e. experimental and control by throwing a coin randomly. In the first meeting they all undergo a face to face training as soon as their demographic questionnaires and consent forms are completed. The control group will receive a face to face training for 4 sessions held fortnight in two months in a healthcare centers. The content of the meetings and is based on the educational needs of individuals and a lecture is presented by the investigator. Each session lasts 45 minutes. The questions will be finally answered and a pamphlet of the contents discussed in the educational sessions will be available to people. A Same educational content in a form of short messages (or SMS) is provided for the experimental group. The researcher will send SMS every other day for two months from 8 am to 8 pm. The sentences are sent regularly. In the first day a message is sent in a form of question or news for the sake of their mental preparation and then its answer is sent in the next SMS, so people will be prepared for the next SMS. The participants are allowed to provide their feedback regarding the screening tests within a month as soon as the study completes. During this period the researcher calls the experimental group every fortnight and answers their questions. Both groups are then asked about the screening tests. Time and visit confirmation of people are checked using the documents at healthcare centers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090123852N1
Registration date: 2015-10-30, 1394/08/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Elham Alihossaini
Name of organization / entity
Ahvaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
Email address
alihossaini.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2016-03-29, 1395/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study of SMS and face to face training impacts on performance health screening tests in middle-aged women in Ahvaz, Iran
Public title
A Comparison of SMS and face to face training impacts on performance health screening tests in middle-aged women in Ahvaz
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: Forty to sixty year old women; having a mobile phone phone; and the eligibility for gynecologic exams, Pap smears, blood biochemical tests (lipid profile, blood glucose, hemoglobin, hematocrit). Exclusion criteria: Suffering from a mental disease; suffering from a any chronic disease such as diabetes, hypertension, etc; does not participate in 2 training sessions.
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Golestan Blvd،Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
6135715794
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.AGUMS.REC.1394.265

Health conditions studied

1

Description of health condition studied
doing gynecologic examinations in middle-aged women
ICD-10 code
Z01.4
ICD-10 code description
Pelvic examination (annual)(periodic)

2

Description of health condition studied
doing Pap smear in middle-aged women
ICD-10 code
Z01.4
ICD-10 code description
Papanicolaou smear of cervix

3

Description of health condition studied
doing blood glucose testing in middle-aged women
ICD-10 code
Z01.7
ICD-10 code description
Laboratory examination

4

Description of health condition studied
doing hematocrit testing in middle-aged women
ICD-10 code
Z01.7
ICD-10 code description
Laboratory examination

5

Description of health condition studied
doing tests of hemoglobin in middle-aged women
ICD-10 code
Z01.7
ICD-10 code description
Laboratory examination

6

Description of health condition studied
doing testing, lipid profiles in middle-aged women
ICD-10 code
Z01.7
ICD-10 code description
Laboratory examination

Primary outcomes

1

Description
doing Pap smear
Timepoint
Before the intervention- one month after the intervention
Method of measurement
Documentation files

2

Description
doing gynecologic examinations
Timepoint
Before the intervention- one month after the intervention
Method of measurement
Documentation files

3

Description
doing tests, lipid profiles
Timepoint
Before the intervention- one month after the intervention
Method of measurement
Documentation files

4

Description
doing testing blood sugar
Timepoint
Before the intervention- one month after the intervention
Method of measurement
Documentation files

5

Description
doing hematocrit blood test
Timepoint
Before the intervention- one month after the intervention
Method of measurement
Documentation files

6

Description
doing tests of hemoglobin
Timepoint
Before the intervention- one month after the intervention
Method of measurement
Documentation files

Secondary outcomes

empty

Intervention groups

1

Description
control group: The control group will receive a face to face training for 4 sessions held fortnight in two months in a healthcare centers. The content of the meetings and is based on the educational needs of individuals and a lecture is presented by the investigator. Each session lasts 45 minutes. The questions will be finally answered and a pamphlet of the contents discussed in the educational sessions will be available to people.
Category
Early detection

2

Description
The intervention group: A Same educational content in a form of short messages (or SMS) is provided for the experimental group. The researcher will send SMS every other day for two months from 8 am to 8 pm. The sentences are sent regularly. In the first day a message is sent in a form of question or news for the sake of their mental preparation and then its answer is sent in the next SMS, so people will be prepared for the next SMS. The participants are allowed to provide their feedback regarding the screening tests within a month as soon as the study completes. During this period the researcher calls the experimental group every fortnight and answers their questions. Both groups are then asked about the screening tests. Time and visit confirmation of people are checked using the documents at healthcare centers.
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
N 3, West, Health Center
Full name of responsible person
Elham Alihossaini
Street address
Farahani St., Alavi St., Kian St.
City
Ahvaz

2

Recruitment center
Name of recruitment center
N 1, West, Health Center
Full name of responsible person
Elham Alihossaini
Street address
South Soroush St., Bani Hashem St.
City
Ahvaz

3

Recruitment center
Name of recruitment center
N1, East, Health Center
Full name of responsible person
Elham Alihossaini
Street address
No. 2, Across from the Park 7 Tir, Martyr Rastegari St., Ayatollah Behbehani Highway.
City
Ahvaz

4

Recruitment center
Name of recruitment center
N2, East, Health Center
Full name of responsible person
Elham Alihossaini
Street address
Asyabad St.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Saki Nader
Street address
Ahvaz Golestan Blvd،Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahnaz Najar
Position
University professor
Other areas of specialty/work
Street address
No. 90, Western ten, Kianpars, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8482
Fax
Email
Najarshanaz@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Elham alihossaini
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61300000000
Fax
Email
alihossaini.e@ajums.ac.ir, e.alihossaini@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Elham Alihossaini
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3000 0000
Fax
Email
alihossaini.e@ajums.ac.ir, e.alihossaini@gmail.com
Web page address

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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