Protocol summary

Study aim
The present study was conducted to determine the impact of educational intervention based on Adult Learning Theory on oral health related quality of life of the elderly.
Design
Clinical trials with intervention and control group (with parallel groups), blind and randomized using 6 blocks.
Settings and conduct
The place of study was all parts of dental faculty of Ahvaz Jundishapur University of Medical Sciences. Participants were randomly divided into experimental and control groups. After pre-test, educational programs were conducted for the interventional group. After one month, the questionnaire was again administered in both groups. Then, the results of pre-test and post-test were compared in each group separately.
Participants/Inclusion and exclusion criteria
Inclusion Criteria for this study were fluency in Persian, informed consent to participate in the study, good psychological and mental status, minimum score of the short cognitive performance test (>6) and literacy. Age less than 60 years old and having psychological disorders were non-admission conditions.
Intervention groups
Intervention group: The intervention included an individual training method using motivational interviewing, an e-learning method in the form of sending three short messages onec a week and a group discussion method that was held in 1 one-hour session. Control group: control group received routine cares of dental clinic of Ahvaz Jundishapur University of Medical Sciences.
Main outcome variables
The overall score of oral health related quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120910010804N13
Registration date: 2018-12-16, 1397/09/25
Registration timing: retrospective

Last update: 2018-12-16, 1397/09/25
Update count: 0
Registration date
2018-12-16, 1397/09/25
Registrant information
Name
Marzieh Araban
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
تهران
Email address
m.araban@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-01, 1396/03/11
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
2017-06-01, 1396/03/11
Actual recruitment end date
2017-07-21, 1396/04/30
Trial completion date
2017-11-30, 1396/09/09
Scientific title
The effect of educational intervention based on Adult Learning Theory on oral health related quality of life among the elderly referred to dental clinic of Ahvaz Jundishapur University of Medical Sciences
Public title
The effect of education on oral health related quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being fluent in persian Informed consent to participate in the study Good psychological and mental status according to the clinician's diagnosis Minimum score of the short cognitive performance test (>6) Having at least ability to read and write
Exclusion criteria:
Receiving privet sectors care
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 92
Actual sample size reached: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Allocating subjects to the study groups (intervention and control) was done random block using six blocks. This was done with WinPepi11.0 software (http://www.brixtonhealth.com/pepi4windows.html). This software generates random groups. In each block, 3 subjects were from the control group and 3 subjects were from the intervention group, which was arranged randomly. Finally, 16 blocks were used. The steps of using the software listed were as follows: ETCETERA, Randomization (Random allocation) , Balanced Randomization, Successive blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to reduce the probability of information bias, the person evaluating the results (post-test) of the educational group was blinded to the participants’ group assignment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahwaz Jundishapur University of Medical Sciences, Esfand street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.AJUMS.REC.1396.315

Health conditions studied

1

Description of health condition studied
Oral health related Quality of life in the elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Oral health related quality of life in the elderly
Timepoint
Before the intervention and one month after the intervention is completed
Method of measurement
Standard questionnaire of Geriatric Oral Health Assessment Index

Secondary outcomes

1

Description
The Score of Effectiveness of Adult Learning Theory
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Questionnaire consisted of 8 researcher-made questions

Intervention groups

1

Description
Intervention group: using face-to-face training methods in the form of 15 minute individual training using motivational interviewing methods, e-learning method (sending educational SMS) which included three short messages that were sent once a week for Individuals and the group discussion method was used as a 1-hour session.
Category
Lifestyle

2

Description
Control group: control group received routine cares of dental clinics of Ahvaz Jundishapur University of Medical Sciences.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry of Ahvaz University of Medical Sciences
Full name of responsible person
Elham Shokouhi
Street address
Ahvaz University of Medical Sciences, Esfand street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
e_shokouhi71@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mohamad Badavi
Street address
Deputy of Research and Technology of Ahvaz University of Medical Sciences, Esfand street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Email
e_shokouhi71@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Marzieh Araban
Position
Assistant Professor of Ahvaz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Ahvaz University of Medical Sciences, School of Public Health, Department of Health Education and Promotion
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8612
Email
araban62@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Araban
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Medical University, Esfand St, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15749
Phone
+98 61 3333 3477
Email
araban62@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Marzieh Araban
Position
Assistant Professor Ahvaz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Ahvaz University of Medical Sciences, School of Public Health, Department of Health Education and Promotion
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8612
Email
araban62@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data studied is sharing after unobtrusive.
When the data will become available and for how long
The access to information after publishing the results
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
The terms of sending the document will be explained to the requesting person.
From where data/document is obtainable
araban62@gmail.com e_shokouhi71@yahoo.com
What processes are involved for a request to access data/document
The request will be answered by the research team after the review.
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