Investigation of microlearning-based education effect on medication adherence and health literacy in elderly population with multimorbidity of Baqiyatallah University Retirement Center
Determining of microlearning-based education effect on medication adherence and health literacy in elderly population with multimorbidity of Baqiyatallah University Retirement Center
Design
A clinical trial with a control group, randomized by the random block allocation method, on 118 patients.
Settings and conduct
After obtaining the IRCT code and written informed consent, the pre-test will be conducted using research tools including the demographic profile questionnaire, Moriski medication adherence questionnaire and health literacy questionnaire. Then the intervention will be done for the test group. The intervention is such that the clips will be sent to the participants in the intervention group through the Ita messenger. In the meantime, the control group will receive the usual care of the treatment center and no intervention will be done for them. But at the end of the study, to comply with research ethics, educational clips designed for participants in the control group will also be sent. The research tools will be completed again 8 weeks after the end of the intervention. Then, the data before and after the intervention in the test and control groups will be analyzed and compared according to the objectives of the research.
Baqiyatallah University Retirement Center
Participants/Inclusion and exclusion criteria
Inclusion criteria
- Age above 60
- Having multiply morbidity (more than one chronic illness)
- Literacy for reading and writing
- Ability to communicate and not having dementia
- With no psychological disorder
- Satisfaction and motivation to attend the study
Not entering criteria
-Having dementia
-Having psychological disorders
Intervention groups
One group (n:60) will receive microlearning method
Main outcome variables
Drug adherence, health literacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191231045966N2
Registration date:2024-04-10, 1403/01/22
Registration timing:prospective
Last update:2024-04-10, 1403/01/22
Update count:0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Hossein Poorcheraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 1111 1111
Email address
hossein75.poorcheraghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of microlearning-based education effect on medication adherence and health literacy in elderly population with multimorbidity of Baqiyatallah University Retirement Center
Public title
Intervention to improve drug adherence and health literacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 60
Having multiply morbidity (more than one chronic illness)
Literacy for reading and writing
Ability to communicate
Satisfaction and motivation to attend the study
Exclusion criteria:
Having dementia
Having psychological disorder
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining permission from the organizational ethics committee of Baqiyatullah University of Medical Sciences and introducing the researcher to the retirees' center of this university, the research samples (118 people) were selected by probability sampling according to the inclusion criteria and using the random block allocation method. These people will be allocated in two control and intervention groups. When we have two groups in the study, the minimum size of the block will be 4, and in this case there will be six possible modes for placing the samples in the blocks (AABB, ABAB, ABBA , BBAA, BABA, BAAB). In which the intervention group is marked with A and the control group is marked with B. First, each of the above situations will be given a number from 1 to 6, and since according to the sample size of 30 The bar was selected from the above possible modes to generate 30 random numbers in the range of 1 to 6 from the website https://www.Randomization.com. In order to hide the random allocation from the researcher, the number of envelopes dark is prepared and each of the random sequences created will be placed on a registration card and inside the envelope, and finally the lid of the envelopes will be glued. The order will be opened and the assigned group of that sample will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Baqiyatallah Hospital
Street address
Tehran Vanak Square Mulla Sadra Street Sheikh Baha'i Street Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1537114359
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.003
Health conditions studied
1
Description of health condition studied
Multimorbidity condition) like hypertension and diabetes)
ICD-10 code
I15
ICD-10 code description
Secondary hypertension
Primary outcomes
1
Description
Drug adherence
Timepoint
After 8 weeks
Method of measurement
Morisky drug adherence questionnaire
2
Description
Health Literacy
Timepoint
After eight weeks
Method of measurement
Health Literacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This study is a randomized clinical trial, which aims to determine the impact of microlearning-based education on medication adherence and health literacy in the elderly of the retirement center of Baqiyatullah University (AS) in 1403. After obtaining permission with the code of ethics (IR.TUMS.FNM.REC.1403.003) from the Organizational Ethics Committee of Baqiyatullah University of Medical Sciences (AS) and introducing the researcher to the retired center of this university, the researcher is one of the elderly who refer to that center, the elderly who meet the criteria had access to the research, the selection and then the samples will be randomly assigned to two experimental and control groups by random block method. To perform randomization, 118 samples were selected by random sampling method and will be allocated in two groups, control and intervention, using random block allocation method. After obtaining written informed consent, the pre-test will be conducted using research tools including the demographic profile questionnaire, Moriski medication adherence questionnaire, and health literacy questionnaire. Then the intervention will be done for the test group. For this purpose, the clips designed based on the micro learning method will be sent to the intervention group and the control group will receive the usual interventions. The educational clips were compiled based on the lesson plan, which was evaluated by 9 nursing and community health professors, and their opinions will be used to make the educational clips. Then the clips will be sent to the participants in the intervention group through the Ita messenger. In the meantime, the control group will receive the usual care of the treatment center and no intervention will be done for them. But at the end of the study, to comply with research ethics, educational clips designed for participants in the control group will also be sent. The research tools will be completed again 8 weeks after the end of the intervention. Then, the data before and after the intervention in the test and control groups will be analyzed and compared according to the objectives of the research.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University Retirement Center
Full name of responsible person
Jamileh Mokhtari Nouri
Street address
Tehran Vanak Square Mulla Sadra Street Sheikh Baha'i Street Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 912 248 8525
Email
jamilmokhtari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology
Full name of responsible person
Jamileh Mokhtari Nouri
Street address
Tehran Vanak Square Mulla Sadra Street Sheikh Baha'i Street Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 912 248 8525
Email
jamilmokhtari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology
Proportion provided by this source
100
Public or private sector
Private
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Jamileh Mokhtari Nouri
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran Vanak Square Mulla Sadra Street Sheikh Baha'i Street Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 912 248 8525
Email
jamilmokhtari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Jamileh Mokhtari Nouri
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran Vanak Square Mulla Sadra Street Sheikh Baha'i Street Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 912 248 8525
Email
jamilmokhtari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Jamileh Mokhtari Nouri
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran Vanak Square Mulla Sadra Street Sheikh Baha'i Street Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1537114359
Phone
+98 912 248 8525
Email
jamilmokhtari@yahoo.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
The data of this study will be published in the form of the policies of the executing organization.
When the data will become available and for how long
After collecting and analyzing data
To whom data/document is available
Access to published information by maintaining the principle of confidentiality will be based on the policies of the article printing journal.
Under which criteria data/document could be used
Based on the policies of the article printing journal.
From where data/document is obtainable
Journal web site
What processes are involved for a request to access data/document
Based on the policies of the article printing journal.