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The Effect of Distance Nurse-led Illness Perception Program on self-efficacy in Management of Heart Failure Patients

Protocol summary

Study aim
Determination of effect of distance nurse-led Illness perception program on self-efficacy in management of Heart Failure patients referring Imam Reza (A.S) specialized and subspecialized polyclinic affiliated to Shiraz University of medical sciences, 2023-2024
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 60 patients. Random Allocation software will be used for randomization.
Settings and conduct
Place of study: Cardiology Clinic of Imam Reza (AS) Shiraz Specialized and Subspecialized Clinic The researcher fills the informed consent form and the questionnaires online from the people who are eligible and willing to participate in the intervention. Due to the educational nature of the intervention, it is not possible to blind the participants, but the data collectors and the statistical analyst will be blinded.The sample size is 60 people and it is divided into two groups of 30, control and intervention.Through the website,15 blocks of 4 blocks including two groups A and B will be randomly designed as (ABAB), (BBAB) and... Next, 60 envelopes, 30 envelopes of paper A and 30 envelopes of paper B, will be prepared and assigned to the desired group.
Participants/Inclusion and exclusion criteria
heart failure patients (class I or II) without acute physical/mental illnesses, not participating in concurrent studies, possess a functional smartphone with usage skills.
Intervention groups
intervention group: Receive routine medical care Receive educational content virtually, phone calls for advice and follow-up Received two comprehensive training sessions for review and questions and answers control group: Receive routine medical care Receive a comprehensive virtual session and training booklets and files (after the intervention)
Main outcome variables
Self-efficacy in Management of Heart Failure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231109060004N1
Registration date: 2024-03-06, 1402/12/16
Registration timing: prospective

Last update: 2024-03-06, 1402/12/16
Update count: 0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Marzie zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 047 4990
Email address
marziezare1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Distance Nurse-led Illness Perception Program on self-efficacy in Management of Heart Failure Patients
Public title
The Effect of Illness Perception Program on self-efficacy in Management of Heart Failure Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being literate in reading and writing Being a Persian language or being able to understand Persian Having a smart phone or computer and the ability to use this tool At least 8 weeks have passed since the diagnosis of heart failure according to the opinion of a cardiologist Class one or two heart failure according to the classification of the New York Heart Association Having personal satisfaction of the people to participate in this research Adults with the age of more than 18 and less than 65 years Absence of known acute physical and mental illness at the same time
Exclusion criteria:
Simultaneous participation in another interventional study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done in an accessible and easy way, and then randomization is done by permutation blocks in 15 blocks of 4, the list of which will be prepared with Random Allocation software. Using this randomization method, the samples will be placed in two intervention (n=30) and control (n=30) groups. . First, 15 blocks of 4 including two groups A and B will be randomly designed through the block design website such as (ABAB), (BBAB), (AABB), (ABBA), (BAAB) and... Next, based on the sample size, 60 envelopes will be prepared, 30 envelopes of paper A and 30 envelopes of paper B. Individuals will be randomly assigned to the desired group in the order of their entry into the study through randomized blocks. For example, according to the ABAB block, patients are assigned to the intervention, control, intervention and control groups in the order of entering the study, and this process will continue until the last block is selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assistant researcher will code the questionnaires using the randomization table, and thus, when dividing the patients into the intervention and control groups, the main researcher will not have a role in allocating the patients to the intervention and control groups. Also, the intervention and control groups are given a random number of 1 or 2, and the main researcher does not know which group each code belongs to after analyzing the data. It should be noted that each person will have a separate user name and password to prevent the dissemination of data between the two groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz, Karimkhan Zand Blvd., next to Hazrat Fatemeh Al-Zahra Mosque, in front of Fars Regional Electric Company
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.145

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
management self-efficacy score in Steca questionnaire
Timepoint
Measuring management self-efficacy At the beginning of the study and eight weeks later, after the intervention
Method of measurement
Steca questionnaire of Cardiovascular management self-efficacy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:For these people, while receiving the usual medical care and interventions by the physician during the first 4 weeks, 1 face-to-face session and 7 sessions of receiving virtual educational content in the form of audio, video and text files in the Skyroom software and providing solutions to improve skills and capabilities. Patients will receive 8 phone calls and in the second four weeks, they will receive one session of educational content and 8 phone calls for consultation and follow-up and re-training if necessary. Two training sessions at the end of the first and second four weeks are also for review and questions and answers.
Category
Rehabilitation

2

Description
Control group: They will receive the usual medical care and interventions that will be prescribed by the physician, and at the end of the intervention, a comprehensive virtual meeting and meeting notebooks and files will be provided to them.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
referring Imam Reza (A.S) specialized and subspecialized polyclinic affiliated to Shiraz University
Full name of responsible person
Seyyed Ali Shamsnia
Street address
Shiraz, Namazi Square, next to Namazi Hospital, Imam Reza (a.s.) special specialized and sub-specialized clinic
City
SHIRAZ
Province
Fars
Postal code
713481473
Phone
+98 71 3212 7000
Fax
Email
motahari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Shiraz, Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
Email
hashempurm@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
29541
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marzie Zare
Position
MSc student of medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Esteghlal Town, Forsatian Blvd., 5th Street, Shahid Rasti
City
Shiraz
Province
Fars
Postal code
7189851768
Phone
+98 71 3651 2330
Fax
Email
marziezare1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Rakhshan
Position
professor of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
: Shiraz, Namazi Square, the entrance to Namazi Hospital, Hazrat Fatemeh College of Nursing and Midwifery
City
shiraz
Province
Fars
Postal code
Phone
+98 71 3647 4254
Email
rakhshanm@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzie Zare
Position
MSc student of medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Esteghlal Town, Forsatian Blvd., 5th Street, Shahid Rasti
City
Shiraz
Province
Fars
Postal code
7189851768
Phone
+98 71 3651 2330
Fax
Email
marziezare1997@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
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
Title and more details about the data/document
After deleting the personal information of patients, it is possible to share other information.
When the data will become available and for how long
2024-2025
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
It is possible to share data if researchers make a reasonable request to the manager responsible for the research.
From where data/document is obtainable
Dr. Mahnaz Rakhshan
What processes are involved for a request to access data/document
After submitting a reasonable request through the responsible academic email (Ms. Dr. Mahnaz Rakhshan), it is possible to share data within a period of about one month after the request.
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