Effect of Caring Program Based on Pender Health Promotion Model on Quality of Life and Self-Care of Patients Undergoing Chronic Heart Failure
Design
In this study, 48 patients with heart failure referred to cardiac clinics of AJA hospitals were randomly selected and subjected to control and intervention in two groups of 24. And each participant was assigned a code.
Settings and conduct
The method of this study was to test the program based on the Pender Health Promotion Pattern and then the impact of this program was evaluated by valid quality of life and self-care questionnaires. While the control group has not implemented any specific and edited program. The place of the study was Aja Hospital (Golestan Patient Heart Clinic).
Participants/Inclusion and exclusion criteria
Input criteria:
Having congestive heart failure diagnosed by acardiologist
Exit criteria:
acute phase of the disease
Intervention groups
The intervention group consisted of 24 people whose program was based on Pender Health Promotion Pattern on this group. The control group included 24 people who did not receive any specific program during the study period.
Main outcome variables
Improving the health and quality of life of subjects
Provide a family-centered empowerment model
Providing suggestions for hospital nurses and educational planners
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150801023446N17
Registration date:2018-01-30, 1396/11/10
Registration timing:retrospective
Last update:2018-01-30, 1396/11/10
Update count:0
Registration date
2018-01-30, 1396/11/10
Registrant information
Name
Fatemeh Teymouri
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5588 0283
Email address
z.farsi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of AJ University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Caring Program Based on Pender Health Promotion Model on Quality of Life and Self-Care of Patients with Chronic Heart Failure
Public title
"Effect of Caring Program Based on Pender Health Promotion Model on Quality of Life and Self-Care"
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to Read and Write
Age Range 31 to 51 Years
Having a known physical disease that affects the quality of life of patients.
Having a known mental disease that affects the quality of life of patients.
Having congenital Heart Failure with Diagnosis of Cardiologist
Ability to Write
Exclusion criteria:
Absence more than Twice the Intervention Sessions
Failure to Follow the Training Sessions in the Test Group more than Two Sessions
Participate in other Educational Programs
Acute Phase of the Disease
Age
From 31 years old to 51 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
patients were first selected using purpose-based sampling. They were then randomly assigned to two 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
The Research Council and the Research Ethics Committee in the Army University of Medical Sciences
Street address
No.1, West Fatemi St., Shahid Etemadzadeh ., Army University of Medical Sciences of the Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1645793914
Approval date
2017-01-19, 1395/10/30
Ethics committee reference number
IR.AJAUMS.REC.1396017
Health conditions studied
1
Description of health condition studied
Congestive heart failure
ICD-10 code
I50.4
ICD-10 code description
Combined systolic (congestive) and diastolic (congestive) heart failure
Primary outcomes
1
Description
Lifestyle Improvement Health
Timepoint
Before the intervention - after intervention
Method of measurement
questionnaire
2
Description
Self care
Timepoint
Before the intervention - after intervention
Method of measurement
questionnaire
3
Description
Quality of Life
Timepoint
Before the intervention - after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" was conducted in group and individual sessions in the form of conversation and interviews and presentation of personal pamphlets.
Category
Lifestyle
2
Description
"Control group:" have not received any intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Military Selection Hospitals
Full name of responsible person
Masoud Chehri
Street address
No.1, West Fatemi St., Shahid Etemadzadeh ., Army University of Medical Sciences of the Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1645793914
Phone
+98 21 8864 4547
Email
Biseton67@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Kamran Azma
Street address
AJA University of Medical Sciences,Etemadzadeh St, Fatemi St, Tehran
City
Tehran
Province
Tehran
Postal code
1645793914
Phone
+98 21 8864 4547
Email
biseton67@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Masoud Chehri
Position
Master of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, West Fatemi St., Shahid Etemadzadeh ., Army University of Medical Sciences of the Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1645793914
Phone
+98 919 445 6348
Fax
Email
biseton67@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Masoud Chehri
Position
Master of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, West Fatemi St., Shahid Etemadzadeh ., Army University of Medical Sciences of the Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1645793914
Phone
+98 919 445 6348
Fax
Email
biseton67@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Masoud Chehri
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.1, West Fatemi St., Shahid Etemadzadeh., Army University of Medical Sciences of the Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1645793914
Phone
+98 21 8864 4547
Fax
Email
Biseton67@yahoo.com
Web page address
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
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
A portion of the data will be available after being unidentifiable
When the data will become available and for how long
Get started 6 months after printing results
To whom data/document is available
Students and professors of medical universities
Under which criteria data/document could be used
There is no other specific condition for obtaining information
From where data/document is obtainable
masoud chehri Tel no: 09194456348
biseton 67@yahoo.com
Library of the Army Medical University
What processes are involved for a request to access data/document
Refer to the Library of the Army Medical University and receive the necessary information and questionnaires