Effects of a web-baseline family educational and supportive program on adherence of treatment and readmission in patients with heart failure after discharge from Shahid Chamran Medical Education Center
Determining the effects of a web-baseline family educational and supportive program on adherence of treatment and readmission in patients with heart failure after discharge from hospital
Design
Clinical trial with intervention and control group, randomized.
With 32 patients in each group
Settings and conduct
The researcher, refer to Shahid Chamran Medical Education Center in Isfahan, select patients with heart failure who have inclusion criteria and randomly divide them into two groups: intervention and control. For intervention group, the program is implemented but control group does not receive any intervention. Then data is collected by questionnaire and analyze.
Participants/Inclusion and exclusion criteria
Age of 30-75 years, Diagnosis of Heart Failure, no history of other chronic diseases except cardiovascular risk factors (diabetes, hypertension, and hyperlipidemia), grade II and III of heart failure based on American Heart Association Classification, having at least one family member capable of receiving the program
Intervention groups
The intervention group receive educational program after discharge from the hospital.
The educational program include sending educational materials through Soroush's messenger and a weekly follow up by telephone.
The control group receive only routine cares.
Main outcome variables
Adherence to therapeutic regimen; re-admission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180227038890N1
Registration date:2018-08-10, 1397/05/19
Registration timing:retrospective
Last update:2018-08-10, 1397/05/19
Update count:0
Registration date
2018-08-10, 1397/05/19
Registrant information
Name
Arman Khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5243 5119
Email address
khajavi.a94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a web-baseline family educational and supportive program on adherence of treatment and readmission in patients with heart failure after discharge from Shahid Chamran Medical Education Center
Public title
Effects of a web-baseline family educational and supportive program on adherence of treatment and readmission in patients with heart failure after discharge from hospital
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Medical diagnosis and registration of heart failure;
Absence of other chronic diseases other than risk factors for heart failure (diabetes, high blood pressure, hyperlipidemia);
Class II and III heart failure;
Having at least one competent family member to receive the program.
Exclusion criteria:
Death
Not wanting to continue cooperation
Failure to receive the program in 3 consecutive days or 5 inconsecutive days
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random: Using the card number:
the even numbers for experimental group and odd numbers for 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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-01-30, 1396/11/10
Ethics committee reference number
396843
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
Adherence to the therapeutic regimen
Timepoint
Before the intervention and immediately after the intervention and one month after the intervention
Method of measurement
Thomas Questionnaire (2004)
2
Description
Re-admission
Timepoint
Immediately after the intervention and one month after the intervention
Method of measurement
Self-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: on the day of patients' discharge from the hospital, in an 1-hour justification session, researcher will explain for intervention group about how program is performed and how to access the content and communication channels. Then the application Soroush will be installed on the phone for the intervention group and will explain how to use it. Then the training program for the intervention group will be start from the first week after discharge and lasts for 1 month. The program consists of two parts. In the first part, the researcher will provide educational materials related to the function, anatomy and physiology of the heart, treatment, medications and their complications, diet, activity and rest, the management of signs and symptoms and disease-related care.The content transmitted through Soroush's messenger will be provided daily to the intervention group in a text and multimedia format. 3 items the on topics listed will be send to the intervention group daily from 9 am to 9 pm. In the Second part, the intervention group will be also followed up weekly by telephone.
Category
Treatment - Other
2
Description
Control group:This group will receive routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Medical Education Center in Isfehan
Full name of responsible person
Arman Khajavi
Street address
Isfahan- Salman Farsi Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3260 0965
Email
Khajavi.a94@gmail.com
Web page address
http://chamran.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Isfahan University Of Medical Sciences
Street address
Hezar jerib street- Isfahan University Of Medical Sciences,
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khajavi.a94@gmail.com
Web page address
https://mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahin moeini
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan Hazard Jarib Street Azadegan Boulevard Alley of Banafsheh
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7621
Email
moeini@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahin moieni
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazard Jarib Street Azadegan Avenue, Banafsheh Street
City
Isfehan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7621
Email
moeini@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arman khajavi
Position
Student-Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jey street
City
Isfehsn
Province
Isfehan
Postal code
81746-73461
Phone
+98 936 551 4671
Email
khajavi.a94@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient information is confidential.
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
General information about participants including age, sex, education, duration of illness and occupation, and the main outcomes including the degree of adherence to the regimen and their re-admission, are average in each group
When the data will become available and for how long
6 months after printing results
To whom data/document is available
People in the field of health
Under which criteria data/document could be used
No response
From where data/document is obtainable
Researcher (Arman Khajuvi) khajavi.a94@gmail.com
What processes are involved for a request to access data/document