Objectives: To assess the effect of self-care education versus no education on self-efficacy in patients with chronic obstructive pulmonary disease.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with chronic obstructive pulmonary disease who will refer to the university hospitals during the study period will be enrolled into the trial.
Inclusion criteria: (a) affected with chronic obstructive pulmonary disease; (b) literate.
Exclusion criteria: history of participation in educational course about chronic obstructive pulmonary disease.
Intervention: Routine care plus 3 educational sessions of 45 minutes on self-efficacy with 3 days interval.
Control: Routine care only.
Primary outcome: Measuring the self-efficacy using Self-efficacy COPD Scale before, immediately after, and one month after intervention.
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504149014N61
Registration date:2015-04-25, 1394/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-04-19, 1394/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care education versus no education on self-efficacy in patients with chronic obstructive pulmonary disease: a randomized clinical trial
Public title
Effect of self-care education versus no education on self-efficacy in patients with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (a) affected with chronic obstructive pulmonary disease; (b) literate.
Exclusion criteria: history of participation in educational course about chronic obstructive pulmonary disease.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: random assignment of the patients to the intervention and control groups using block permutation.
Blinding: Not blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-10-21, 1393/07/29
Ethics committee reference number
D/P/16/35/9/3558
Health conditions studied
1
Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Measuring the self-efficacy
Timepoint
before, immediately after, and one month after intervention
Method of measurement
using Self-efficacy COPD Scale
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine care plus 3 educational sessions of 45 minutes on self-efficacy with 3 days interval.
Category
Other
2
Description
Routine care only
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
university hospitals
Full name of responsible person
Negar Kazemi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
School of Nursing and Midwifery
Full name of responsible person
Negar Kazemi
Position
Nursing Student
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
ndka25@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Afsar Omidi
Position
Master of Community Health Education
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
omidi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Public Health, Hamadan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)