The effect of self- care program based on the Orem self –care model on level of fatigue and quality of life of people with chronic obstructive pulmonary disease
As mentioned study population are people with chronic obstructive pulmonary disease and purpose of this study assessment effect of self- care program based on the Orem self –care model on level of fatigue and quality of life of people with chronic obstructive pulmonary disease total sample size 66 people and 33 people in each group that taken randomly assigned to intervention and control groups. in this study The Blinding in data collection is done using 2 research assistant. Intervention by the researcher will be implemented after the needs assessment is a self-care program based on Orem Self Care Model designed in 4 sessions of 30 to 45 minutes for individual and group that the intervention group will be trained at the end of the fourth session taught content in the form of a booklet will be given to the intervention group. After 2 months, data collection is done by research assistant. In this study, Self-Care is independent variable and dependent variable is fatigue and quality of life. The inclusion criteria of chronic obstructive pulmonary disease at stage 2 or 3 based on GOLD criteria and the exclusion criteria exacerbation and their inability to self-care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030432764N2
Registration date:2017-05-19, 1396/02/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-19, 1396/02/29
Registrant information
Name
Shahla Abolhassani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5648
Email address
abolhasani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research and technology affairs of shahrekord univercity of medical sciences
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self- care program based on the Orem self –care model on level of fatigue and quality of life of people with chronic obstructive pulmonary disease
Public title
The effect of Orem Self Care Model on patients with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Specialist physician diagnosis of COPD and documented in the log file؛ patient hospitalized؛ The patient's medical condition is stable؛ Patients with stage 2 or 3 Gold System؛ Lack of debilitating disease؛ The patient can do her daily activities without the need for oxygen؛ Willingness to cooperate in the study؛ Lack of mental illnesses and not used psychiatric drugs ؛ Do not treated patients fatigue with medication؛ understand the Conversation with the Persian language؛ The patient or the patient's family have literacy
Exclusion criteria: Lack of motivation to continue cooperation؛ Based on Orem's self-care form calculated Patient self care needs 50 Percent and more؛ Lack of self-care program؛ exacerbation patient؛ At the same time receive other training programs
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
in this study the samples are randomly and using computer software divided into two experimental and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Approval date
2017-02-26, 1395/12/08
Ethics committee reference number
IR.SKUMS.REC.1395.315
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive: airway disease NOS lung disease NOS
Primary outcomes
1
Description
fatigue
Timepoint
Before and after the intervention.
Method of measurement
Fatigue Severity Scale (FSS)
2
Description
Quality of Life
Timepoint
Before and after the intervention
Method of measurement
Quality of life questionnaire (SF-12)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: self-Care program Based on the needs of patients and based on the Orem self-care framework Will be designed. This self-care program is performed for 4 weekly individual and group sessions for 30 to 45 minutes and during a month in the intervention group. At the end of a four-session will be given training manual that includes a comprehensive collection of all the tips during four sessions and They will be asked to self-care program will run for two months. During the two months through a call or Show up and Self-assessment form review the implementation of the program and the samples are tips for better performance.
Category
Behavior
2
Description
Control group: The control group receive treatment and routine care through visiting by his doctor's at office.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Iman reiszadeh
Street address
Hajar hospital, parastar street, shahrekord
City
Shahrekord
2
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Iman reiszadeh
Street address
Kashani hospital, parastar street, shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice-chancellor for research and technology affairs of Shahrekord University of Medical Sciences
Full name of responsible person
Kamal solati
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellor for research and technology affairs of Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Iman reiszadeh
Position
medical surgical Nursing Graduate Student
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
Ireiszadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Shahla abolhassani
Position
Phd
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
sh_abolhassani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Iman reiszadeh
Position
medical surgical Nursing Graduate Student
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
ireiszadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)