The Effect of Smartphone-Based Educational Program on Self-Efficacy of Patients Undergoing Heart Valve Surgery and the Family Caregivers' Burden: Parallel Randomized Clinical Trial
Determining the impact of the designed educational program based on smartphones on the self-efficacy of patients undergoing heart valve surgery and the care burden of family caregivers.
Design
A parallel randomized clinical trial including a sample size of 60 people will be conducted in a randomized block fashion in two intervention and control groups. The random allocation sequence and the list of blocks will be obtained by the statistical consultant and with the help of the website https://www.sealedenvelope.com.
Settings and conduct
In the intervention group, in addition to heart valve replacement clinic training, training is done using an Android application. The control group will only use hospital and clinic training.
Participants/Inclusion and exclusion criteria
Patients have undergone mechanical heart valve replacement surgery for the first time.
The age range of people is between 18 and 65 years.
Have an Android smartphone.
People who have hearing, visual and touch disorders or who are not able to speak Persian language.
Intervention groups
The smartphone-based application is installed by the researcher for the patient and caregiver in the intervention group, and they are taught how to use the application in a session. Both groups will use the routine training programs of the heart clinic. The control group will not receive additional training and will only benefit from clinic training.
Main outcome variables
Self-Efficacy ; burden of care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210714051889N1
Registration date:2023-03-11, 1401/12/20
Registration timing:registered_while_recruiting
Last update:2023-03-11, 1401/12/20
Update count:0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
mohammad zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3872 0878
Email address
zarei.mohammad72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-30, 1401/11/10
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Smartphone-Based Educational Program on Self-Efficacy of Patients Undergoing Heart Valve Surgery and the Family Caregivers' Burden: Parallel Randomized Clinical Trial
Public title
The Effect of Smartphone-Based Educational Program on Self-Efficacy of Patients Undergoing Heart Valve Surgery and the Family Caregivers' Burden
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of people should be between 18 and 65 years.
Have an Android smartphone.
Patients undergo mechanical valve surgery for the first time.
Exclusion criteria:
Suffering from known physical and mental diseases that affect the quality of life, such as dialysis, or other known mental problems, such as depression and schizophrenia, which require special medication or diet (according to the patient's self-report).
People who have participated in another educational program during the research.
People who have hearing, visual and touch disorders or who are not able to speak Persian language.
People who underwent valve repair or biological valve.
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by block method. First, the random allocation sequence and block list will be obtained by the statistical consultant. The website https://www.sealedenvelope.com is used to generate a random sequence for block-type randomization so that there is no limit on the number of blocks for random allocation. In this research, the block method with a volume of 4 is used to create a random allocation sequence. According to the total number of samples required for the study, which was 60 family members and patients (30 patients and family members in the test group (A) and 30 family members and patients in the control group (B)), in 15 quadruple blocks including Two groups A and B will be randomly selected through the site.
Based on the list of randomized blocks of four prepared, a trained nursing expert outside the research group is responsible for registering participants and assigning patients randomly, after the entry of each patient, according to the 15 blocks of four prepared in the first stage, each patient is Randomly placed in group A (intervention) or B (control group). For example, after randomly selecting the BBAB block, the patients were placed in the control, control, intervention and control groups in the order of their entry. And the sampling process is done consecutively in the same way until the sampling is completed, and the code of each patient was also assigned to his family member. People are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks.
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 in research of the Faculties of Pharmacy, Nursing and Midwifery, Shahid Beheshti Un
Street address
Resalat Highway, Kerman Street, Shahid Mousavi Street
City
tehran
Province
Tehran
Postal code
1634678694
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.166
Health conditions studied
1
Description of health condition studied
of Patients Undergoing Heart Valve Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy of patients undergoing heart valve surgery
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Patient's demographic information questionnaire and Sullivan Cardiac Self-Efficacy Questionnaire (SCSES) are completed by the patient. Sullivan's self-efficacy questionnaire has 16 questions, which evaluates the level of confidence and self-efficacy of patients in the field of compliance with general care, control of disease symptoms, and compliance with medication orders. The questionnaire is scored on a 5-point Likert scale, including completely = 4, very much = 3, almost = 2, a little = 1 to not at all = 0.
2
Description
Caring burden of family caregivers
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
The caregiver demographic information questionnaire and the CBI care burden questionnaire are completed by the caregiver. The care burden questionnaire has 24 statements, which was created in 1989 by Novak and Guest to measure the objective and mental burden of care and measures the burden of mental care with more emphasis. This questionnaire has five subscales and includes time-dependent caregiving burden, evolutionary caregiving burden, physical caregiving burden, social caregiving burden, and emotional caregiving burden. ), it measures partially correct (score 2), correct (score 3) and completely correct (score 4), therefore, the scores obtained from this questionnaire are from zero to 96.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is in the form of providing an application (Android application) that can be installed on the phone, which provides information about heart valve failure and dysfunction, familiarity with drugs and the necessity of using them, the importance of the role of self-efficacy in the patient, and the beneficial effects of self-care and emphasis. on the importance of the role of caregivers and reducing the burden of care and how to take proper care of oneself and its dimensions and the importance of how to manage symptoms and signs in emergency situations and the importance of making changes in lifestyle for the patient and caregiver (including following a proper diet, mobility and exercise, It includes medication adherence, smoking cessation, weight control) and other educational information. The smartphone-based application is installed by the researcher for the patient and caregiver in the intervention group, and a session is taught on how to use the application (in order to prevent access to the application by the control group during the intervention, a special password is required to enter the program given to a phone). At the same time, the intervention group will use the routine training programs of the heart clinic. During the implementation of the intervention until the re-completion of the questionnaires, the researcher was in contact with the caregivers and the patient through telephone calls and questions and answers with the participants through the formation of a group in the available social network (if the participants are satisfied). And while following up by phone, their questions will be answered. After 8 weeks from the end of the intervention, the questionnaires will be given to the intervention group again.
Category
Other
2
Description
Control group: At the same time, the control group will benefit from the clinic's routine training in the form of face-to-face training and hospital pamphlets. The relevant questionnaires are designed face-to-face or press-line and are completed by the research sample (including the patient and his caregiver) and face-to-face training sessions are arranged in one to two sessions according to the needs of the individual and then to answer questions no. The phone will be provided to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares and Imam Hossein Hospital
Full name of responsible person
MOHAMMAD ZAREI
Street address
South Rodaki Street, Shahid Ali Mazaheri Alley, Moghadam Alley 2, No. 12, Unit 1
City
TEHRAN
Province
Tehran
Postal code
1346756168
Phone
+98 913 443 6396
Email
zarei.mohammad72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Chamran Highway, Yemen St., Shahid Arabi St., building number 2, fifth floor
City
TEHRAN
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Web page address
https://research.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
MOHAMMAD ZAREI
Position
Bachelor's degree nursing student majoring in special care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 12, Unit 1, 2 Moghadam Alley, Shahid Ali Mazaheri Alley, South Rodaki St., Tehran
City
tehran
Province
Tehran
Postal code
1346756168
Phone
+98 21 2624 4174
Email
zarei .mohammad72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Neda Sanaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Wali Asr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Faculty of Nursing and Midwifery
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
nedasanaie@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mohammad zarei
Position
Master's degree student in nursing majoring in special care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
South Rodaki Street, Shahid Ali Mazaheri Alley, Moghadam Alley 2, No. 12, Unit 1
City
tehran
Province
Tehran
Postal code
1346756168
Phone
+98 21 2624 4174
Email
zarei.mohammad72@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available