Determining the effect of a self-management program on the level of hope and anxiety in patients with heart failure
Design
A clinical trial with a control group, with parallel groups, Unblinded, non-randomized, on 100 patients
Settings and conduct
Location: Selected hospitals by Shahid Beheshti University of Medical Sciences, Tehran. Patients will be randomly divided into intervention and control groups. In the intervention group, patients are provided with a self-management program along with standard Procedure, and in the control group, Solely the standard procedure is performed. After the intervention, the level of anxiety and hope will be measured using the Questionnaire and then the information will be compared using SPSS software version 26. The Researchers and Participants are Unblinded.
Participants/Inclusion and exclusion criteria
Entry Requirements:
People between the ages of 18-80 years.
Have the ability to use virtual messengers.
Not having previous training in a self-management program.
Suffering from Class 2 and 3 heart failure according to the file
Non-Entry Conditions:
Aggravation of the disease and transfer of the patient to the intensive care unit
Reluctance to continue participating in the research
Intervention groups
In the experimental group, the self-management program was provided to the patients along with the usual care, and in the control group, the usual care was implemented.
Main outcome variables
Anxiety; Hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200727048221N1
Registration date:2022-11-22, 1401/09/01
Registration timing:retrospective
Last update:2022-11-22, 1401/09/01
Update count:0
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
Hanieh Molaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3339 5205
Email address
haniehmolaee991373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
2020-11-21, 1399/09/01
Actual recruitment end date
2021-07-22, 1400/04/31
Trial completion date
2021-07-22, 1400/04/31
Scientific title
Investigation of the effect of Self-Management Programs on Hope and Anxiety in Heart failure patients
Public title
Investigation of the effect of Self-Management Programs on Hope and Anxiety in heart failure patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 18-80 years.
Have the ability to use virtual messengers.
No previous training in a self-management programs.
Suffering from Class 2 and 3 heart failure according to the file
Exclusion criteria:
Aggravation of the disease,the occurrence of other medicine disorders, and any emergency event that causes the patient to be transferred to the intensive care unit.
Acute mental disorders such as psychosis and acute depression that require hospitalization.
Reluctance to continue participating in the research
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The Random allocation of the two groups under study is done by block random allocation with SPSS software
The Blocks are designed in quadruplets that are all randomly determined by SPSS
Randomization Tool: SPSS Software
How to build a random sequence: SPSS Software
Explanation about the concealment: the allocated blocks are placed in the envelopes of the letter. After each person refers, an envelope is given to the researcher, then the envelope is opened and the person who refers is placed in one of the two groups. It should be noted that The researcher does not know the content inside the envelopes.
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
Shahid Beheshti University of Medical Sciences ethics committee
Street address
Valiasr Niayesh intersection
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2020-07-27, 1399/05/06
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.142
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Anxiety is measured before and after the intervention
Method of measurement
Heart Anxiety Questionnaire
2
Description
Hope
Timepoint
Hope is measured before the intervention and after the intervention
Method of measurement
Hope Miller Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, patients are provided with a self-management program along with routine care. The self-management program will be implemented by creating a group in WhatsApp or Telegram cyberspace in six sessions, which includes a self-management program, and patients are constantly monitored and followed up individually by phone call and up to Uncertainty does not end with a full understanding of the training program, and if any problems occur in the process of conveying the concepts of the program, a face-to-face class will be formed.
Category
N/A
2
Description
Control group: The control group also receives routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Hanieh Molaee
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 11 3339 5205
Email
haniehmolaee137399@gmail.com
2
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Hanieh Molaee
Street address
Intersection of Valiasr Niayesh Street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 911 948 8626
Email
haniehmolaee991373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Shahid Beheshti School of Nursing and Midwifery , niyayesh intersection
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 11 3339 5205
Email
haniehmolaee137399@gmail.com
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
Marzieh Pazokian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti College of Nursing and Midwifery, Intersection of Valiasr Niayesh Street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 11 3339 5205
Email
haniehmolaee137399@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marzieh Pazokian
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti College of Nursing and Midwifery, Intersection of Valiasr Niayesh Street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 31 3339 5205
Email
haniehmolaee137399@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Molaee
Position
collegian
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti College of Nursing and Midwifery, Intersection of Valiasr Niayesh Street
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 11 3339 5205
Email
haniehmolaee137399@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
Not applicable
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