The Effect of Multimedia Education Based on reflective learning on Quality of Life, Cardiac Anxiety and Adherence to therapeutic regimen in Patients with Heart Failure
The effect of multimedia education with reflective learning on quality of life, cardiac anxiety and adherence to treatment in heart failure patients
Design
This study is a randomized clinical trial Without blinding
Settings and conduct
The statistical population of this study will be heart failure patients admitted in CCU ward of Peymanieh Jahrom Hospital in 1999-98. In this study, the sample size of the study was based on studies using two means comparison method for each group. The sampling method in this study is convenience. Then patients will be randomly assigned to intervention and control groups
Participants/Inclusion and exclusion criteria
Age under 55 years, Grade 1 to 3 heart failure
Intervention groups
The first intervention group will be multimedia education. In the second intervention group, in addition to multimedia training, the reflective method will be used. In the third group the control group. Only the training CD will be given,
Main outcome variables
Quality of life, cardiac anxiety, adherence to treatment regimen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N1
Registration date:2020-02-05, 1398/11/16
Registration timing:retrospective
Last update:2020-02-05, 1398/11/16
Update count:0
Registration date
2020-02-05, 1398/11/16
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Multimedia Education Based on reflective learning on Quality of Life, Cardiac Anxiety and Adherence to therapeutic regimen in Patients with Heart Failure
Public title
The Effect of Education on Quality of Life, Cardiac Anxiety and Adherence to Treatment in Heart Failure Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
To under 55 years old,
Grade 1 to 3 heart failure,
Exclusion criteria:
Patients' unwillingness
Age
From 40 years old to 55 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
At first, sampling will be done by convenience method and then randomly divided into two groups of control and intervention. For this purpose, 120 cards will be provided first, 40 cards A, 40 cards B and 40 cards C, these 120 cards will be placed in an envelope and each patient will be asked to carry one card. Take a coincidence. Each card with the names A, B, C actually represents two intervention groups (multimedia learning ) , (multimedia learning with reflective learning) and a 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
Ethical Committee of Fasa University of Medical Sciences
Street address
Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
City
Fasa
Province
Fars
Postal code
86688-74616
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.FUMS.REC.1398.099
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50.9
ICD-10 code description
heart failure
Primary outcomes
1
Description
Quality of life
Timepoint
Immediately - one month later - three months later
Method of measurement
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
2
Description
Cardiac Anxiety
Timepoint
Immediately - one month later - three months later
Method of measurement
The cardiac anxiety questionnaire Eifert
3
Description
Adherence to treatment regimen
Timepoint
Immediately - one month later - three months later
Method of measurement
Morisky Medication Adherence Scale (MMAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, multimedia education will be provided.The multimedia method will use video, slide show and educational pamphlets. The training program will be held in four two-hour sessions. The content of the training film will be produced with the advice of a cardiologist, nutritionist and psychologist and nursing faculty members. The film will be filmed at the Fasa University of Medical Sciences virtual training center and the educational content will be approved by the professors and director of the Department of Cardiology, Nutrition, Psychology and Nursing at Fasa University of Medical Sciences. Including 1- Symptoms and Symptoms of Heart Failure and Prevention of Heart Failure
Category
Lifestyle
2
Description
In the second intervention group, in addition to multimedia training, the training will be followed in a reflective learning based on the Johns model. This model consists of five steps -1. Event description: At this stage the event or experience describes the important causes and contextual factors associated with it, and in general, key issues in describing the event are addressed to clarify the experience.2. Reflection: This phase examines the thoughts and feelings of oneself and others and the consequences of the actions taken. Sample questions at this stage are: What was I trying to achieve? Why did I do it? What are the consequences of my actions [for the patient and family, for myself, for the people I work with]? When it happened, how did I feel about that experience? What was the patient feeling about it? How do I know what the patient is feeling about it?3. Investigating the influential factors: In this phase, the influence of internal, external and individual factors on the individual's decisions and actions is examined. Questions at this stage can include the following. What internal factors influenced my decision making and actions? What external factors influenced my decisions and actions? What sources of knowledge have or should have influenced my decision making and actions?4. Evaluating Alternative Strategies: At this point, the questions are: Could I handle this situation better? What other options were there for action? What were the consequences of the other choices?5. Learning: This stage describes the changes that have occurred in one's experiences, knowledge, ethical attitudes and self-awareness as a result of an event. An example of the question at this stage is: Given my past experience and future performance, how can I make sense of this experience? How do I feel about this experience right now? Am I considering taking effective action to support myself and others as a result of this experience? How has this experience changed my approach to performance? All stages of the Johns model will be discussed after viewing the film and based on the film content.
Category
Other
3
Description
Control group: The control group will received a training package on heart failure
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Payamanieh hospital in Jahrom
Full name of responsible person
Mostafa Bijani
Street address
Shahid Sattari Street
City
Fasa
Province
Fars
Postal code
74617-47377
Phone
+98 71 5331 5012
Fax
+98 71 5331 4021
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Fargham
Street address
Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
City
Fasa
Province
Fars
Postal code
86688-74616
Phone
+98 71 5335 0994
Email
bizhani_mostafa@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant Professor - Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
City
Fasa
Province
Fars
Postal code
86688-74616
Phone
+98 71 5335 0994
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
City
Fasa
Province
Fars
Postal code
86688-74616
Phone
+98 71 5335 0994
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Assistant professor- Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
City
Fasa
Province
Fars
Postal code
86688-74616
Phone
+98 71 5335 0994
Email
bizhani_mostafa@yahoo.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
Not applicable
Title and more details about the data/document
The consent form will be completed by the participants
When the data will become available and for how long
Complete the study and publish the article
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Implementation in other centers or other disease
From where data/document is obtainable
Mostafa Bijani Assistant Professor Department of Nursing, School of Nursing and Midwifery Fasa University of Medical Science. bizhani _mostafa@yahoo.com
What processes are involved for a request to access data/document
Send project mananger email. Mr. Mostafa Bijeni
bizhani_mostafa@yahoo.com