This study aims to determine the effect of drug management application on drug adherence and consequences in older adults
Design
A randomized controlled trial of 192 people will be used at randomization at https://www.Randomization.com
Settings and conduct
This study will be performed on the elderly with inclusion criteria referred to Ziaian Hospital. The drug management application will be installed on their phone with the aim of improving the process of drug use. The Morisky questionnaire will be used to evaluate the effectiveness of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age between 60-74 years old 2. Conscious consent to enter the study 3. Taking more than five types of medication during day 3. Writing and reading literacy 4. Having a smart mobile phone and the ability to use it 5. The ability to communicate and not having dementia 6. Having any diseases of hypertension, diabetes, chronic obstructive pulmonary disease (COPD) 7. Use only Tab in the medication regime. Exclusion criteria: 1. Reluctance to continue attending the study 2. Hospitalization or death of the elderly 3. Use of rare, expensive, and special drugs 4. Use of injectable drugs (such as insulin in diabetes )
Intervention groups
The drug application is installed on the intervention group's mobile phone, and reminders about when to take the drugs will be set. In the meantime, the control group receives the usual care of the center and no intervention is made for them. But at the end of the study, in order to observe the research ethics and if the application is effective on the drug adherence of the intervention group, this program will be installed on their smartphone and the method of using it will be taught.
Main outcome variables
Drug adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191231045966N1
Registration date:2021-07-18, 1400/04/27
Registration timing:prospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
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
2021-08-23, 1400/06/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An investigation of the drug management application effect on drug adherence and consequences in older adults
Public title
Effect of mobile application on drug use in older adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 60-74 years old
Conscious consent to enter the study
Taking more than five types of medication during the day
Reading and writing literacy
Having a smart phone and the ability to use it
Ability to communicate and not having dementia
Having any of the following diseases: hypertension, diabetes, chronic obstructive pulmonary disease (COPD)
Use only the drug form of the tablet (Tab) in the drug program
Exclusion criteria:
Reluctance to continue participating in the study
Hospitalization or death of the participats
Use of rare, expensive and special drugs
Use of injectable drugs (such as insulin in diabetes)
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a randomized clinical trial that will be conducted to determine the effect of drug management application on drug adherence and consequences in older adults. The study population is all community older adults who take five or more drugs in their daily medication regimen and were referred to the elderly clinic in Ziaian Hospital. The method is؛ after obtaining permission to conduct research from the Ethics Committee of the School of Nursing and Midwifery and Rehabilitation with IR.TUMS.FNM.REC.1400.068 ID, the researcher will choose among the elderly who referred to this center and meet the inclusion criteria, then the samples are randomly assigned to the experimental and control groups by random blocking method. To perform randomization, 192 samples are selected by the available sampling method, and using the random blocking method, they are assigned in two groups of control and intervention. Depending on the sample size, 48 blocks of 4 (or 32 blocks of 6) are required for random block allocation. The intervention group will be displayed with A and the control group with B. The website https://www.Randomization.com will be used for random blocking method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to blinding random allocation from the researcher, a dark envelope sample size is prepared and each of created random groups will be written on a card and put inside the envelope. At the beginning of the registration of individuals, according to the order of arrival of the samples, one of the envelopes is opened in order and the assigned group of that sample is specified.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
School of Nursing and Midwifery & Rehabilitation, Doctor Mirkhani (Eastern Nosrat), Tohid square, District, Tehran provenance
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
IR.TUMS.FNM.REC.1400.068
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Drug adherence
Timepoint
In the present study, Morisky Adherence Questionnaire (MAQ) will be completed by both control and intervention groups before the start of the study and after 8 weeks from the beginning of the study.
Method of measurement
Morisky Adherence Questionnaire (MAQ)
Secondary outcomes
1
Description
Drug consequences
Timepoint
In the present study, a researcher-made questionnaire on drug consequences before and 8 weeks after the intervention will be completed by the control and intervention groups.
Method of measurement
researcher-made drug consequences questionnaire
Intervention groups
1
Description
Intervention group: The drug application is installed on the intervention group's mobile phone, and reminders about when to take the drugs will be set.
Category
Lifestyle
2
Description
Control group: Control group receives the usual care of the center and no intervention is made for them. But at the end of the study, in order to observe the research ethics and if the application is effective on the drug adherence of the intervention group, this program will be installed on their smartphone and the method of using it will be taught.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Hamidreza Hekmat
Street address
Ziaeian Hospital, Aboozar square, Qazvin Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
ziaeian@tums.ac.ir
Web page address
https://ziaeian.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Geranmay
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Fax
+98 21 6105 4170
Email
nursing_intl@tums.ac.ir
Web page address
http://www.fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeypoor
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran .IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 912 491 3843
Email
pashaeypoor.sh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeypoor
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran .IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 912 491 3843
Email
pashaeypoor.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahzad Pashaeypoor
Position
Associate Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 912 491 3843
Email
pashaeypoor.sh@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
In this study, all the information obtained after completing the Morisky Drug Adherence Questionnaire and the researcher-made Drug Consequences Questionnaire can be shared after identifying individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
All researchers working in academic and scientific institutes can use the results of this study without any preconditions.
From where data/document is obtainable
Shahzad Pashaeypoor
Associate Professor of Nursing
Department of Community Health and Geriatric Nursing, School of Nursing & Midwifery
Tehran University of Medical Sciences
00989124913843
Pashaeypoor.sh@gmail.com
Zipcode: 1419733171
What processes are involved for a request to access data/document
Without providing any specific documentation, the information will be available to them as soon as possible in the form of the specified instructions.