Protocol summary

Study aim
Investigating the effect of education with using mobile software on medication adherence in patients' with hearth failure
Design
In this study, 80 patients with heart failure who meet the conditions for entering the study will be included in the study and will be randomly assigned to two intervention and control groups using color cards. In the intervention group, clients and their caregivers. In addition to receiving face-to-face educational materials and pamphlets, training will also be provided using mobile software, and in the control group of clients and their caregivers, educational materials will be provided face-to-face and pamphlets.
Settings and conduct
The present research will be carried out experimentally and by randomized clinical trial method in Ayatollah Taleghani Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: suffering from heart failure, age over 18 years, access to a mobile phone with the ability to install software, reading and writing literacy
Intervention groups
In the intervention group, in addition to receiving face-to-face educational materials and pamphlets, clients and their caregivers will also be trained using mobile software.
Main outcome variables
medication adherence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210131050189N4
Registration date: 2023-03-30, 1402/01/10
Registration timing: prospective

Last update: 2023-03-30, 1402/01/10
Update count: 0
Registration date
2023-03-30, 1402/01/10
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education with using mobile software on medication adherence in patients' with hearth failure
Public title
The effect of education with mobile software on medication adherence in patients' with hearth failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from heart failure Age above 18 years access to a mobile phone with the ability to install software Literacy for reading and writing
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Before the start of the intervention, 40 white and 40 black cards are prepared and for randomization, all the cards are placed in an envelope, then the cards are drawn randomly and numbers from 1 to 80 are drawn in order. is placed Then each card is placed in a sealed envelope and its number is written on the card, and when each patient enters the study, a special envelope will be opened for him from 1 to 80 and assigned to the intervention and control group.
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
Shahid Beheshti University of Medical Sciences (Research Ethics Committees)
Street address
Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198571744
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.SBMU.SME.REC.1401.103

Health conditions studied

1

Description of health condition studied
Hearth failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
medication adherence
Timepoint
At the time of discharge
Method of measurement
medication adherence questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, in addition to receiving face-to-face educational materials and pamphlets, clients and their caregivers will also be trained using mobile software. At the time of visiting the clinic, before hospitalization or during hospitalization, the link to receive the software through barcode will be provided to clients and after installing the software on the phones of the clients and their companion, the software will be introduced to them. In the software, the conditions of hospitalization in the department, the officials and the physical space of the department, heart diseases, measures, drugs, diet of heart patients, and the way of discharge and post-discharge care are described.
Category
Other

2

Description
Control group: the clients and their caregivers will be provided with face-to-face educational materials and pamphlets.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
(Ayatollah) Taleghani Educational Hospital
Full name of responsible person
Raziyeh Ghafouri
Street address
Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
َAfshin Zergi
Street address
Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh ghafouri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@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
By email to the corresponding author
When the data will become available and for how long
En After the publication of the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
More research
From where data/document is obtainable
By email to the corresponding author
What processes are involved for a request to access data/document
By email to the corresponding author
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