This study examines the effectiveness of intervention based on Health Belief Model on Self-Care Behaviors in patients with Heart Failure in Yasuj.
Design
This study is a Field Trial study that consists of 105 patients with Heart Failure who visit the heart part of Imam Sajjad Hospital and and heart clinics in Yasuj. The subjects were randomly divided into intervention and control groups and assigned to each one a code.
Settings and conduct
In this study, The population studied were patients with heart failure in Yasuj. An intervention program tailored to the patients was designed and Trainings were carried out by an experienced trainee and was done with the previous coordination at home. The interval between the training sessions was three days. After two weeks from the last session of the training, the form of evaluation of patients' performance was gathered in form of face-to-face of the patients and data was collected.
Participants/Inclusion and exclusion criteria
Entry conditions
1. Having heart failure that is diagnosed by a cardiologist
2. Resident in Yasuj City
3. Satisfaction for entering the study
4. Ability to communicate effectively with educator
Exit Conditions
1. Unwillingness to continue cooperation after entering the study
2. Failure to perform Self-Care skills due to aging or paralysis
Intervention groups
In this study, the Intervention Group included 52 out of 105 Heart Failure Patients that is diagnosed by cardiologist and resident in Yasuj, who Educational Intervention was taken about them.
vice chancellor for research yasug university of medical sciences
Expected recruitment start date
2016-05-19, 1395/02/30
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of intervention effectiveness based on Health Belief Model on Self-Care Behaviors in Heart Failure Patient
Public title
Intervention based on Health Belief Model on Self-Care Behaviors in patients with heart failure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having Heart Failure Diagnosed by Plan Consultant Cardiologist
Resident in Yasuj City
Satisfaction for entering the study
Ability to communicate effectively with educator
Exclusion criteria:
Unwillingness to continue cooperation after entering the study
Failure to perform self-care skills due to aging or paralysis
Age
From 18 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The type of sampling was selective and the type of assignment was simple random. First, they were enrolled according to the eligibility criteria for a total of 105 patients with heart failure. Then, with a simple random allocation approach allocated in two groups of compared with 53 individuals and intervention group with 52 individuals.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Motahari Blvd, Yasuj University of Medical Science, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591775114
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.yums.REc.1395.32
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
150
ICD-10 code description
omplicating: abortion or ectopic or molar pregnancy (O00-O07, O08.8) obstetric surgery and procedures (O75.4) due to hypertension (I11.0) with renal disease (I13.-) following cardiac surgery or due to presence of card
Primary outcomes
1
Description
Perceived Susceptiblity
Timepoint
6 weeks before the intervention and 6weeks after the intervention
Method of measurement
Questionnaire
2
Description
Perceived Severity
Timepoint
6 weeks before the intervention and 6weeks after the intervention
Method of measurement
Questionnaire
3
Description
Perceived Benefits
Timepoint
6 weeks before the intervention and 6weeks after the intervention
Method of measurement
Questionnaire
4
Description
Perceived Barriers
Timepoint
6 weeks before the intervention and 6weeks after the intervention
Method of measurement
Questionnaire
5
Description
Selfe-Efficacy
Timepoint
6 weeks before the intervention and 6weeks after the intervention
Method of measurement
Questionnaire
6
Description
Selfe -Care Behavior
Timepoint
6 weeks before the intervention and 6weeks after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Selfe-Care Behavior
Timepoint
6weeks before the intervention and 6weeks after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention Group: Implementation of Educational Intervention by implementing Training Classes in Intervention Group
Category
N/A
2
Description
Control group: No Educational Intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
CCU Department of Imam Sajjad Hospital
Full name of responsible person
Hengameh Akbari
Street address
Shahid Jalil Ave., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591775114
Phone
+98 74 3322 8081
Email
amlak.akbari@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vic Chancelor for yasuj university of medical science
Street address
Motahari Blivd vice Chancelloryasuj university of medical science
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591775114
Phone
+98 74 3322 8081
Email
amlak.akbari@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr Ali Mossavizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Motahari Blvd, Yasuj university of medical science
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591775114
Phone
+98 74 3334 6078
Fax
+98 74 3322 6715
Email
mousavizadeh.ali@yums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Ali Mossavizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Dastjerdy Ave., EmamHossen square, School of health, Yasuj University of Medical Science, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591873944
Phone
+7 433228081
Fax
+98 74 3322 6715
Email
mousavizadeh.ali@yums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hengameh Akbari
Position
MA
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Dastjerdi Ave., EmamHossin square, school of health, Yasuj University of Medical Sciences, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591775114
Phone
+98 74 3322 8081
Fax
+98 74 3322 6715
Email
amlak.akbar1@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not 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
There is no particular explanation.
When the data will become available and for how long
For three years after the publication of the article
To whom data/document is available
Will be available publicly.
Under which criteria data/document could be used
With the written permission of the authors, the data will be usable.
From where data/document is obtainable
Refer to the Responsible Author.
What processes are involved for a request to access data/document
To the address of the Vice-Chancellor of Research, Yasuj University of Medical Sciences, to provide information to him.