Evaluating the effect of using smartphone application on drug self-efficacy and drug adherence in elderly polypharmacy
Design
Clinical trial with the control group, with parallel groups, without blinding, randomized on 60 elderly subjects, randomized with random blocks of randomization site
Settings and conduct
This two-group clinical-randomized trial study will be performed on the elderly who refer to the Danesh Amuz Health Center and Sadaf Health Center and have the inclusion criteria. Sixty elderly people will be randomly divided into control and intervention groups. In the first session, the researcher will introduce the plan for both groups in a different session, and after the session, individuals will fill in the questionnaires of demographic information, drug self-efficacy, drug adherence, and the list of drugs used. In the second session, which is dedicated to the intervention group, the application will be installed on mobile phones. During this period, the researcher will respond to the problems of the intervention group, and this process will continue for eight weeks. The control group will receive the same routine medication training by the health center personnel. Both groups' self-efficacy and drug adherence questionnaires will be measured at the beginning of the study and at the end of the intervention.
Participants/Inclusion and exclusion criteria
Admission: polypharmacy and the ability to use smartphones.
Exclusion: elderly people who get a high drug self-efficacy score and a high drug adherence score at the beginning
Intervention groups
The intervention group will receive the drug application and the control group will receive the routine drug training of the treatment centers.
Main outcome variables
Increasing the rate of drug self-efficacy and adherence to the drug in the elderly of polypharmacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210704051777N1
Registration date:2021-09-15, 1400/06/24
Registration timing:retrospective
Last update:2021-09-15, 1400/06/24
Update count:0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
Shokoufeh Shafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2676 5506
Email address
shafiees971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examination of the effect of using smartphone application on drug self-efficacy and drug adherence in elderly polypharmacy
Public title
Evaluation of the effect of drug application in polypharmacy elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people who take more than three drugs a day.
Elderly who have the ability to use smartphones
Exclusion criteria:
Elderly people who get a drug self-efficacy score of ٢٩ or higher at the beginning of the study.
Elderly people who get a high drug adherence score of zero at the beginning of the study.
Elderly who have cognitive impairment
Age
From 60 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using the permutation block method, they were divided into control and intervention groups. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks, AB and BA. One of the blocks was randomly selected. If the first block, AB, was selected, the first person was assigned to group A and the second person to group B. And this process continued until all the samples were assigned. The characteristic of this method was that the two study groups had equal numbers. All steps were performed using Random Allocation software.
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-02-02, 1399/11/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.019
Health conditions studied
1
Description of health condition studied
Poly pharmacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increase in morriski drug adherence score
Timepoint
8 weeks after installing the drug application
Method of measurement
Drug Adherence Questionnaire Moriski
Secondary outcomes
1
Description
Drug self-efficacy
Timepoint
8 weeks after installing the drug application
Method of measurement
Seams Drug Self-Efficacy Questionnaire
Intervention groups
1
Description
Intervention group:they receive a drug application ;the content of this application has been prepared and edited by a geriatric master's degree student and under the supervision of professors of Mashhad University of Medical Sciences. The elderly can use this application to access all their common drugs and increase their information about drugs. All drug descriptions in this application are simple and fluent and can be understood by all ages .This application has visual and textual content about how the drugs function in the elderly body, ways to take medicine, pharmaceutical forms and safe dosage of the drug in the elderly.This application has educational videos about insulin injection, how to use inhalation spray and eye drops, ear and nose.The researcher gives complete training to the elderly to use the application.Then installs the application on the elderly phone and encourages the elderly to use the application with continuous follow-up. This process will continue for 8 weeks.During this period, the elderly can raise their possible problems or any medical questions through the communication link in the application with the researcher, to which the researcher will respond and take appropriate action.At the end of the study, the questionnaire of drug self-efficacy and medication adherence will be filled out again by the elderly.
Category
Treatment - Drugs
2
Description
Control group:They will receive routine medication training by health center staff
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Danesh َAmuz Health Center
Full name of responsible person
Simin Gazani
Street address
Danesh Amuz Square
City
Mashhad
Province
Razavi Khorasan
Postal code
1981634547
Phone
+98 51 3893 2322
Email
Drgazani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hasan Jahed Tehrani
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3800 2101
Email
Jahedh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Najme Valizade
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1512
Email
valizadehn@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najme Valizade
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1512
Email
valizadehn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najme Valizade
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1512
Email
valizadehn@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the information about the main outcome
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Nurses
Under which criteria data/document could be used
In research on the elderly
From where data/document is obtainable
Shokoufehshafiee, shafiees971@mums.ir
What processes are involved for a request to access data/document