Determining the effect of using energy conservation methods on the quality of life and depression of heart failure patients
Design
Clinical trial with control group, with parallel groups, without blinding and randomized on 100 patients. For randomization, the method of balanced blocks and blocks of four will be used by statistical software.
Settings and conduct
Before the intervention, the demographic, Minnesota, and Beck depression tools will be filled by the intervention and control group at the Shahid Rajaei Cardiovascular Education, Research and Treatment Center. The intervention group will be taught energy conservation methods and this group should use these methods for 6 weeks.
The control group will also be given routine training during hospitalization and before discharge by the patient's doctor and nurse . After 6 weeks, Minnesota and Beck instruments will be filled by both groups.
Participants/Inclusion and exclusion criteria
entry conditions:
Having heart failure with class 3 and 4 according to the classification of the New York Heart Association with the diagnosis of the relevant doctor; Suffering from heart failure for at least one year; Age range 18-60 years; Ability to implement energy conservation methods; Speak in Farsi; Having hearing and sight; Ability to read and write; Not having any underlying diseases
Non-entry conditions:
Failure to apply the methods taught during 6 weeks; Not answering the phone when completing self-report checklists; A person's refusal to continue participating in energy conservation method training programs; death of the patient
Intervention groups
The intervention group will be given teaching energy conservation methods, and the control group will be given routine training by the patient's doctor and nurse.
Main outcome variables
improving the quality of life; Reduce depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240220061055N1
Registration date:2024-04-30, 1403/02/11
Registration timing:registered_while_recruiting
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Seyed Motahare Nabizade
Name of organization / entity
Shahid Rajaei Heart and Vascular Training, Research and Treatment Center, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 13 4223 5821
Email address
motaharenabizade@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-29, 1403/02/10
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using energy conservation methods on quality of life and depression heart failure patients.
Public title
Investigating the effect of energy conservation methods on the quality of life and depression of heart failure patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having heart failure with class 3 and 4 according to the classification of the New York Heart Association with the diagnosis of the relevant doctor
Suffering from heart failure for at least one year
Age range 18-60 years
Ability to implement energy conservation methods
Speak in Farsi
Having hearing and sight
Ability to read and write
Willingness to participate in the study
Exclusion criteria:
Having underlying diseases such as: neurological diseases (stroke), types of myopathy, rheumatology diseases (lupus), neuromuscular diseases (Guillen Barre) and concomitant pulmonary diseases (COPD)
Alcohol and drug abuse
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients to enter the study (100 people), in a random block with a size of four with the help of computer program They will be divided into two equal groups of 50 people.In other words, 25 blocks of four will be formed, and in each block, two people will be randomly assigned to the intervention group (group A) and two people will be assigned to the control group (group B). For example, blocks of 4 would include the permutations: AABB, ABAB, ABBA, BABA, BBAA, and BAAB. Each time, one of these permutations will be randomly selected and based on that, patients will be assigned to intervention and control groups.
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 Shahid Rajaei Cardiovascular Education, Research and Treatment Center
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.RHC.REC.1402.028
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Quality of life score in Minnesota questionnaire
Timepoint
Evaluation of the quality of life score at the beginning of the study and 6 weeks after teaching energy conservation methods
Method of measurement
Minnesota Questionnaire
Secondary outcomes
1
Description
Depression score in Beck questionnaire
Timepoint
Evaluation of the depression score at the beginning of the study and 6 weeks after teaching energy conservation methods
Method of measurement
Beck questionnaire
Intervention groups
1
Description
Intervention group: The intervention group, which includes 50 heart failure patients, will be taught energy conservation methods.Energy conservation methods about being calm in work, stabilizing the position, positive attitude, pursed lip breathing , planning and prioritizing activities, how to do housework, personal hygiene, making the bed, dressing, cooking, Washing clothes, washing dishes, shopping, gardening, leisure time and taking care of the child are energy consuming activities.
Category
Lifestyle
2
Description
Control group: The control group will be given routine training during hospitalization and before discharge by the patient's doctor and nurse about the correct use of medications, salt intake restriction, daily weighing, warning about symptoms of disease exacerbation and proper physical activity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Cardiovascular Training, Research and Treatment Center
Full name of responsible person
fidan shabani
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
Email
shabani.f@rhc.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaei Cardiovascular Training, Research and Treatment Center
Full name of responsible person
hooman bakhshande
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
Email
hooman.bakhshande@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaei Cardiovascular Training, Research and Treatment Center
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 Rajaei Cardiovascular Training, Research and Treatment Center
Full name of responsible person
seyde motahare nabizade
Position
Specialist doctor of the academic staff
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
motaharenabizade@rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Training, Research and Treatment Center
Full name of responsible person
Faranak Kargar
Position
Specialist doctor of the academic staff
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
drkargarf@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Training, Research and Treatment Center
Full name of responsible person
marzie mirtajadini
Position
Specialist doctor of the academic staff
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center., Valiasr Ave., Niayesh Intersection.,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
m.mirtajadini@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
Undecided - It is not yet known if there will be 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
Except for the name and surname, other demographic information and the score of the quality of life and depression questionnaire can be shared
When the data will become available and for how long
Beginning of the access period from 1403
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of study tools and results
From where data/document is obtainable
motaharenabizade2@gmail.com
What processes are involved for a request to access data/document
To access the data, send a message to my email. The response time will be 5 to 10 days after viewing.