Improve self-care behaviors in patients with heart failure
Design
Randomized controlled clinical trial
Settings and conduct
Patients admitted to ccu or post ccu will be investigated. Then, 110 patients with eligibility criteria will be selected using the sequential method after signing written informed consent form. Then patients will be allocated into two groups: intervention and control.
Participants/Inclusion and exclusion criteria
Having a smartphone or tablet under the Android system can be installed on the application and can be used.
Having a weak to moderate self-care based on self-care
questionnaire for European cardiac insufficiency.
Having ages 18 to 65 years.
In class 2 and 3 of HF classes.
Intervention groups
Patients in the control group will be under the routine care of the hospital and patients in the intervention group will receive a smartphone application in addition to the usual care of the application program
Main outcome variables
Self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171225038069N1
Registration date:2018-07-22, 1397/04/31
Registration timing:prospective
Last update:2018-07-22, 1397/04/31
Update count:0
Registration date
2018-07-22, 1397/04/31
Registrant information
Name
Nahid Kiyarousta
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6660 8107
Email address
n.kiaroosta@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education by smartphone-based application on self-care behaviors in patients with heart failure
Public title
Effect of smartphones applications on heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of two groups should not be under any investigation or research
Having a smartphone or tablet under the Android system where the application can be installed and capable of using it
Having fluency in Persian
The patient is admitted at least once due to Heart Failure disease.
Patients should be admitted by a physician due to an exacerbation of heart failure
Having a weak to moderate self-care based on self-care questionnaire for European heart failure
Having ages 18 to 65 years
Having class 2 and 3 in Heart Failure classes
Patients have been admitted for an exacerbation of heart failure to the hospital and are not at the compensatory phase of the disease.
Not having any other chronic disease that requires frequent hospitalization, such as cancer, severe kidney disease and dementia
Exclusion criteria:
The patient's admission for any reason other than the illness studied
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were allocated to the intervention and control groups using the block randomization method with the block size of four.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411449006
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
self care
Timepoint
Measure self-care (before intervention) and 3 months after using the application
Method of measurement
European self-care questionnaire for patients with heart failure (12 items) Jarasma et.al
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group will receive an Android application in addition to the usual care of the application on the smartphone. This application is a software application that can transmit educational content in the form of media, text, audio and video, and so on,besides training, the ability to evaluate patient symptoms, medication reminders, appointments with a doctor, and tests. In addition, patients can contact the care team through this program and interact with the questions they are asked to receive and receive answers through this process. A 20-30 minute session will be taught to patients admitted to the cardiac care unit on how to use this program. The following day, the hospital will be contacted and questions will be asked about the patient's problems in using this application to resolve potential problems. Every week for 6 weeks, and after that, the patient will be in contact for 10 to 15 minutes for a further 2 months with the patient, and will emphasize the need for the program to be used. The daily use of the studied patients will be reviewed by the application program and will provide health messages and incentives for the program to be applied. In this way, the interaction between patients and peer reviewers will be done, which will be tailored to the needs of patient sand their conditions. Patients will use this program for 3 months, after a period of five months, they will contact the patients in the intervention group and the control group will be contacted with the help of the peer reviewer. It will be useful for them to use the European Questionnaire Complete and send to the reader. A smartphone-based application for patients in the control group is also sent after completion of data collection to be installed.
Category
Other
2
Description
Control group: patients in the control group will be placed under the common care of the hospital.