Determination of the Effect of a Designed Energy Conservation Program on Fatigue and Frequency Admission in Patients with Heart Failure
Design
The present study is a clinical trial with a control group with parallel random groups of 48 people.
The intervention is done by random assignment method using randomized permutable blocks with size 6 block (using a random permutation table).
Settings and conduct
This study is a randomized controlled clinical trial study. Which will be conducted in the CCU sections of the educational hospitals and outpatient clinics of the educational hospitals, which will be evaluated for 48 patients with heart failure.
The fatigue measurement scale will be used in the pre-test to determine the fatigue level with both groups. After collecting pre-test data, the educational program is designed and implemented based on the results of the analysis of the findings and the individual interview with the patient and one of the family members of the patient. After the intervention, the severity of fatigue and the frequency of hospitalization of the patients were recorded and Checked out.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1 - Sustained heart failure with Classes 2, 3 and 4 according to the classification of the New York Heart Association with the diagnosis and approval of the relevant physician.
2. Ejection fraction below 45%
3. Having heart failure for at least 6 weeks
4. Having fatigue more than 18 (moderate and severe)
Exclusion criteria
Missing more than one training session
Intervention groups
The intervention group receive 12 weeks of appropriate educational support programs, including five face-to-face training sessions of 45 minutes per person.
The control group will receive routine training and will not receive new training.
Main outcome variables
Energy conservation in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171203037737N3
Registration date:2019-04-08, 1398/01/19
Registration timing:registered_while_recruiting
Last update:2019-04-08, 1398/01/19
Update count:0
Registration date
2019-04-08, 1398/01/19
Registrant information
Name
sedighe ghobadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 9717
Email address
ghobadian.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tailored education of energy conservation on Fatigue level and hospitalization times in patients with heart failure
Public title
Effect of education on Fatigue level and hospitalization times in patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Sustained heart failure with grades 2, 3 and 4 based on the classification of the New York Heart Association with the diagnosis and approval of the relevant physician.
Ejection fraction below 45%
Heart failure for at least 6 weeks
Familiarity with Farsi
Having a fatigue score of 18 (moderate and severe)
Complete vigilance and awareness of time and place
Exclusion criteria:
Sustained heart failure with grades 2, 3 and 4 based on the classification of the New York Heart Association with the diagnosis and approval of the relevant physician.
Ejection fraction below 45%
Having a fatigue score of 18 (moderate and severe)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be run by randomized block method, which will be executed using block size 6 (using a random permutation table).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundishapur University of Medical Sciences
Street address
Ahvaz.Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-02-16, 1397/11/27
Ethics committee reference number
IR.AJUMS.REC.1397.871
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
Fatigue Score in the Crap Questionnaire
Timepoint
At regular intervals from the time of pretest (before the intervention) up to 3 months after the pretest
Method of measurement
Krupp Fatigue Severity Scale
2
Description
hospitalization times
Timepoint
In two separate periods of 1.5 months and 3 months
Method of measurement
Quantitative and according to the frequency of admission to the follow-up period
Secondary outcomes
1
Description
The ability to maintain energy
Timepoint
At regular intervals from the time pre-test (before intervention) up to three months after pre-test
Method of measurement
Krupp Fatigue Severity Scale
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive 12 weeks of appropriate educational support program that will be tailored to each individual patient's situation, including five 45-minute face-to-face training sessions for each person. (First visit, and every three weeks a training session after the first visit and for the first 12 weeks of the first visit, the third week, the sixth week, the ninth week and the twelfth week in the ccu section or the outpatient clinics of the heart and the vascular )
Category
Rehabilitation
2
Description
Control group: The control group received routine training, including oral instructions from the department or clinic for heart failure, and will receive no new training.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
CCU departments and outpatient clinics in Ahvaz educational hospitals
Full name of responsible person
Marzieh Asadizaker
Street address
Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8708
Fax
+98 61 3373 8333
Email
marziyehasadizaker@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Asadizaker
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
marziyehasadizaker@gmail.com
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
50
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
Leila Haghighii
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
L.haghighii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Habib Haybar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3333 0074
Fax
+98 61 3333 2036
Email
haybar-h@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
simin Jahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
jahani-s@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information about patients will be confidential.
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
No - There is not 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
Data on the main outcome of the study will be published in the article.
When the data will become available and for how long
Two months after the completion of the research
To whom data/document is available
Professors, researchers and students
Under which criteria data/document could be used
research
From where data/document is obtainable
Magazine site
What processes are involved for a request to access data/document
Download the article from the magazine site
Comments
Try to get the article free of charge to applicants