Detemining the effect of preventive behavioral training on Haddon's strategy on self-care behavior and the consequences of disease in heart failure patients
Design
A randomized clinical trial with a control group, with two parallel groups
Settings and conduct
The present study will be a randomized clinical trial involving 96 patients with heart failure admitted to Farshchian hospital in Hamadan. Patients will be randomly divided into experimental and control groups. In the experimental group, the researcher will present the Hadon's strategy Training in three sessions of group training for 60 minutes . Hadon's strategy is to educate self-care behavior to reduce risk factors and complications of the disease. The first session will provide an overview of the nature and causes of the disease and warning signs. In the second session, the focus will be on the training of the diet and medication.The third session will focus on teaching balance between activity and rest, daily weighing and monitoring of symptoms of exacerbation, stress control and urinary output.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having literacy of reading and writing, Diagnosis of heart failure confirmed by a cardiologist, Patients over the age of 18 years
Exclusion criteria: Unwilling to continue participating in the study, Failure to attend more than two training sessions
Intervention groups
In the intervention group, the researcher will deliver the Hadon's strategy Training in three sessions for 60 minutes. Hadon's strategy is to educate self-care behavior to reduce risk factors, severity and complications of the disease (shortness of breath, lower extremity edema, rest and activity disorder, chest pain, memory impairment and alertness and judgment) and rehabilitation.The control group will receive only routine training.
Main outcome variables
Self-care, complications of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N26
Registration date:2019-08-02, 1398/05/11
Registration timing:prospective
Last update:2019-08-02, 1398/05/11
Update count:0
Registration date
2019-08-02, 1398/05/11
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preventive behavioral training with Haddon's strategy on self-care behavior and the consequences of disease in heart failure patients.
Public title
effect of preventive behavioral training with Haddon's strategy on self-care behavior and the consequences of disease
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over the age of 18 years
Diagnosis of heart failure confirmed by a cardiologist
Having literacy of reading and writing
Exclusion criteria:
Failure to attend more than two training sessions
Unwilling to continue participating in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using 6-point permutational block method by computer software
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.umsha.REC.1398.339
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
Complications of the disease
Timepoint
Before and after educational intervention
Method of measurement
Complications checklist
Secondary outcomes
1
Description
Self-care
Timepoint
Before and after educational intervention
Method of measurement
Self-Care of Heart Failure patients Index
Intervention groups
1
Description
Intervention group: In the intervention group, the researcher will present the Hadon's strategy Training in three sessions for 60 minutes . Hadon's strategy is to educate self-care behavior to reduce risk factors and complications of the disease. The first session will provide an overview of the nature and causes of the disease and warning signs. In the second session, the focus will be on the training of the diet and medication.The third session will focus on teaching balance between activity and rest, daily weighing and monitoring of symptoms of exacerbation, stress control and urinary output.
Category
N/A
2
Description
Control group: Patients in the control group will receive only routine care and training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Arezoo Karampourian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.karampourian@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
S.bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Karampourian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.karampourian@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Karampourian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.karampourian@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afsaneh Hoseini
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
a.karampourian@umsha.ac.ir
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