Evaluation of the effect of individually designed energy conservation training on self-care empowerment and quality of life of patients with heart failure
Determining the impact of the individually designed energy conservation training program on empowering self-care and quality of life in heart failure patients
Design
Clinical trial with control group, with parallel, uncorrected, randomized block of 4 on 66 patients
Settings and conduct
The training program for the test group will be designed and implemented based on the results of the analysis of the findings and individual interview with the patient and a member of the patient's family. In the heart clinic, heart ward and CCU ward of Khorramabad Ashayer and Madani Hospital
Participants/Inclusion and exclusion criteria
Having heart failure with class2, 3 and 4
2. Patients over 18 years old
3. Ejection fraction below 45%
4. Familiarity with Persian language
5. Full alertness and awareness of time and place
6. Having a moderate to poor self-care score.
7. Having a quality of life score higher than 24
Intervention groups
For patients in the intervention group, 4 face-to-face training sessions of 30 minutes per person will be performed every 3 weeks. Patients in the control group will receive routine nursing training after discharge or routine clinic training.
Main outcome variables
Increasing the level of awareness of patients with heart failure, improving self-care, improving the quality of life, increasing the independence of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220612055150N1
Registration date:2022-07-06, 1401/04/15
Registration timing:registered_while_recruiting
Last update:2022-07-06, 1401/04/15
Update count:0
Registration date
2022-07-06, 1401/04/15
Registrant information
Name
Maryam Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3343 4750
Email address
mari01taheri06@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-28, 1401/04/07
Expected recruitment end date
2022-07-18, 1401/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of individually designed energy conservation training on self-care empowerment and quality of life of patients with heart failure
Public title
Evaluation of the effect of individually designed education on empowerment of heart failure patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having heart failure with class 3, 2 and 4 according to the classification of the New York Heart Association with the diagnosis and confirmation of the relevant doctor.
Patients over 18 years old
Ejection fraction below 45%
Familiarity with Persian language
Full alertness and awareness of time and place
Having a self-care score of 29 to 60 which is moderate to poor self-care (32)
Having a quality of life score higher than 24 which is average and poor quality of life (34
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization of 4 pieces, we have 6 blocks of 4 pieces, which according to the sample size, we randomly select 17 times from these 6 blocks. In the 4 pieces blocks, A is the intervention group and B is the 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
Ethics Committee of Jundishapur Ahvaz University of Medical Sciences
Street address
Unit 4, Faraz Building, Shokoofeh St., Imam Square
City
Khoramabad
Province
Lorestan
Postal code
6813918975
Approval date
2022-05-28, 1401/03/07
Ethics committee reference number
IR.AJUMS.REC.1401.079
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
Quality of life score and self-care score of heart failure patients
Timepoint
The beginning of the study and 12 weeks later
Method of measurement
European Heart Failure Self-Care Behavior Questionnaire and Minnesota Quality of Life Questionnaire with Heart Failure
Secondary outcomes
1
Description
Quality of life score
Timepoint
At the beginning of the study and 12 weeks after the study
Method of measurement
Minnesota Heart Failure Quality of life Questionnaire with 21 questions
Intervention groups
1
Description
Intervention group: For patients in the intervention group, 4 face-to-face training sessions of 30 minutes will be conduced for each person every 3 weeks.(The first session, The third week ,The six week and the ninth week will be in the CCU, cardiology department or outpatient cardiology clinics).In the first session, prioritized trainings will be provided for each patient based on the needs assessment obtained from the information of the questionnaires in the form of face-to-face training and questions and answers. At the end of the first session, patients are emphasized on registering edema in the lower extremities, number of times sitting during the day, recording posture after doing housework, walking, climbing stairs, sleeping position, performing daily activities, recording shortness of breath, anxiety And depression in the notebook and present it to the next session or send via SMS to the researcher. In this case, the patient is encouraged to perform self-monitoring actions and doing these things becomes a daily routine for the patient and his family. In the second, third and fourth sessions, according to the patient's records of his condition, the trainings will be repeated in the areas required by the patient and the patient's possible questions will be answered.
Category
Other
2
Description
Control group: Patients of the control group will receive routine nursing training after discharge or routine clinic training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ashayer Hospital and Madani Hospital
Full name of responsible person
Maryam Taheri
Street address
Khyrabad, Shghayegh Square
City
Khoramabad
Province
Lorestan
Postal code
6819789691
Phone
+98 66 3341 9123
Email
mari01taheri06@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnosh zakerkish
Street address
Ground floor, Vice Chancellor for Research and Technology, Ahvaz University of Medical Sciences, University City, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
irct@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Taheri
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 4, Faraz Building, Shokoofeh St., Imam Square
City
Khoramabad
Province
Lorestan
Postal code
6813918975
Phone
+98 66 3343 4750
Email
mari01taheri06@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marziyah Asadizaker
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Boulevard, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 5630
Email
Asadizaker-m@ajmus.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Taheri
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
4 Floor.Faraz Building.,Shokofh Ave.,Emam Square.,Khoramabad City,Lorestan Stat
City
Khoramabad
Province
Lorestan
Postal code
6813918975
Phone
+98 66 3343 4750
Fax
Email
mari01taheri06@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
No - There is not 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
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of participants, information on the main outcome
When the data will become available and for how long
Start data access 3 months after printing results
To whom data/document is available
Researchers and students in academic institutions
Under which criteria data/document could be used
Use documentation in an article or dissertation
From where data/document is obtainable
By e-mail address
What processes are involved for a request to access data/document
Apply by e-mail and it will be sent within 15 days