Determining the effect of palliative care on anxiety thoughts and life expectancy in heart failure patients referred to the heart departments of hospitals affiliated to Kerman University of Medical Sciences in 2023
Design
A clinical trial with a control group, on 80 patients with heart failure, it will use for randomization using the block randomization method.
Settings and conduct
This study will be conducted on heart failure patients referred to heart departments of hospitals affiliated to Kerman University of Medical Sciences. It has 2 control and intervention groups.The intervention group will receive the palliative care protocol that includes 8 sessions, and the control group will receive only routine care. Patients with heart failure will be selected in the accessible way and then will be placed in 2 control and intervention groups by block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years-Having heart failure-Ability to understand and speak Persian-Ability to answer questionnaire questions
exclusion criteria: No participation in more than two training sessions, No answering more than a third of the questions-Sensory disorders such as vision and hearing problems that affect learning
Intervention groups
The intervention group will receive the educational protocol along with routine care. The educational protocol of the study includes a two-week palliative care program in the form of one-hour training sessions, four times a week. The control group will receive only the routine care of heart failure patients.
Main outcome variables
The score obtained from Schneider's life expectancy questionnaire
The score obtained from the Wells Anxiety Thoughts Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231223060506N1
Registration date:2024-01-21, 1402/11/01
Registration timing:prospective
Last update:2024-01-21, 1402/11/01
Update count:0
Registration date
2024-01-21, 1402/11/01
Registrant information
Name
Rezvan Askarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3236 8665
Email address
re.askarpour7879@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-09, 1402/11/20
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The effects of palliative care on anxious thoughts and life expectancy in patients with heart failure
Public title
"The effects of palliative care on anxious thoughts and life expectancy in patients with heart failure referred to the heart departments hospitals"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having heart failure
Ability to understand and speak Persian
Ability to answer questionnaire questions
Exclusion criteria:
Not participating in more than two training sessions
Not answering more than a third of the questions
Sensory disorders such as vision and hearing problems that affect learning
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected by continuous sampling and the patients will be placed in 2 control and test groups by Block Balanced Randomization method. Allocation sequence will be done using the free web system http://www.randomization.com/.In this way, the number of samples in each block is determined by 4 people and the letter A will be considered for the intervention group and the letter B will be considered for the control group. And finally, by confirming the creation of the allocation sequence in the above system for 20 blocks, the allocation sequence for 80 samples will be created by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the governor's envelope, and as a result, the concealment of the allocation will be considered and respected. Based on the qualified samples, an envelope will be removed by the researcher using random sampling method and finally the method of random allocation of research samples will be determined.
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 Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, The beginning of Haft Bagh Road, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.KMU.REC.1402.348
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
Anxious thoughts
Timepoint
Anxiety thoughts will be measured before the intervention and immediately after the intervention.
Method of measurement
Wells Anxious thoughts Scale
2
Description
life expectancy
Timepoint
Life expectancy will be measured before the intervention and immediately after the intervention.
Method of measurement
Schneider life expectancy scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group includes patients with heart failure referred to the heart departments of hospitals affiliated to Kerman University of Medical Sciences. The intervention group receives the educational protocol along with routine care. The educational protocol of the study includes a two-week palliative care program in the form of one-hour training sessions, four times a week. The educational content is narrated by experts in the field of palliative care, and will be implemented by a researcher who is trained through a supervisor who is a professor of palliative medicine. In the first week of the sessions, when the patients are in the hospital, it will be performed individually for the patients. At the time of discharge, they are asked to go to the hospital in order to receive the continuation of the palliative care program on certain days, and the continuation of the educational sessions in the second week for the patients is carried out in the patient education center in groups (small groups) in coordination with the relevant hospitals. The content of the program is mostly related to the aspects of increasing the awareness and knowledge of patients in relation to their disease, increasing the aspects of self-care, techniques to control anxiety and anxious thoughts, and ways to increase self-confidence. During the intervention, the researcher will evaluate, educate and counsel the patients in the first session. Patients' knowledge and ability in self-management, family support system, and their educational and counseling needs, including heart failure symptoms and self-care, will be evaluated. An educational brochure will also be provided to patients. During the first week, when the meetings are held individually, the guidelines for heart failure will be explained and the researcher will provide emotional support to the patients by encouraging them to express their feelings. She will actively listen to the patient's responses by encouraging them to express their feelings and it will support them in taking small steps to solve the problem. And in the second week, the meetings are in groups , It will be explained in relation to the solutions of having a healthy lifestyle and strengthening your spirit, and how to control and manage the disease and strengthen self-confidence.
Category
Behavior
2
Description
Control group: Usual care in heart failure will be provided to patients.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Street address
Kerman University of Medical Sciences, Haft Bagh Road first، Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5820
Email
m.ahmadinejad@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abedin Iranpour
Street address
Kerman University of Medical Sciences, Haft Bagh Road first، Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
a.iranpour@kmu.ac.ir
Grant name
Deputy of research and technology, Kerman University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Askarpour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Midwifery Nursing School,Kerman University of Medical Sciences, Haft Bagh Road first، Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
re.askarpour7879@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Esmat Nouhi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Razi Midwifery Nursing School,Kerman University of Medical Sciences, Haft Bagh Road first، Kerman
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
smnouhi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Askarpour
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi Midwifery Nursing School,Kerman University of Medical Sciences, Haft Bagh Road first، Kerman
City
Kerman
Province
Kerman
Postal code
761613555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
re.askarpour7879@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