A comparative study of the effects of individual versus group Self-management education on the health-related quality of life of patients with chronic obstructive pulmonary disease
he purpose of this study is assessing the effect of individual versus group self-management education on the health-related quality of life of patients with chronic obstructive pulmonary disease . The study population is 150 patients with chronic obstructive pulmonary disease hospitalized in Hajar and Ayatollah Kashani hospitals that have inclusion criteria.Allocation of samples into three groups is based on non-randomized and controlled manner.For this purpose, first the names of three groups is written and draw by lot.Then patients on continuous order respectively put into groups that drawn by lot.So that the first 50 patients put in control group,then with one week gap to discharge the latest sample of this group, the next 50 patients put in individual group, then with one week gap to discharge the latest sample of this group, the last 50 patients put in group education.All subjects will receive standard care . Individual education group will receive face-to-face education while group education depending on the number of people with Chronic obstructive pulmonary disease in research environments at the same time will receive education through group discussion in groups up to 8 to 10 people . Educational content is same in all three groups , including self-management education for chronic obstructive pulmonary disease . Number of education sessions , including four sessions for 1 hour will be on consecutive days. Before and three months after the intervention , health-related quality of life for all groups with St. George's questionnaire will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070828781N2
Registration date:2016-10-08, 1395/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-08, 1395/07/17
Registrant information
Name
Farshad Heidari Beni
Name of organization / entity
Iran Univercity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 38 3372 3354
Email address
heydari-bani.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research funding of Iran University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of individual versus group Self-management education on the health-related quality of life of patients with chronic obstructive pulmonary disease
Public title
The impact of education on quality of life of people with chronic obstructive pulmonary disease
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria were: age 40 to 75 years, confirmed by a physician in the case of patient , in phase two or three disease (diagnosed by a doctor) , have the ability to understand and speak the Persian language , have the physical ability for interview and questionnaire , not Participate in earlier chronic obstructive pulmonary disease self-management programs , absence of mental illness , absence of pulmonary tuberculosis , active cancer and severe neurological problems , lack of hearing problems and problems associated problems.
Exclusion criteria: disease progression to end-stage (four) or death of the patient , any signs , symptoms or diagnosis of wheezing (asthma) , bronchiectasis, pulmonary tuberculosis , pneumoconiosis and acute congestive heart failure during the study , absent in one education session , unwillingness to continue cooperation
Age
From 40 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethic Committee of Iran University Of Medical Science
Street address
Iran University of Medical Sciences ,Hemat Highway
Individual education group depending on individual learning level and stage of disease will receive face-to-face education. Educational content includes self-management education for chronic obstructive pulmonary disease , which is composed of two components: stable chronic obstructive pulmonary disease self-management involves identifying and reducing risk factors , medication, non-pharmacological , monitoring and follow up and self-management in exacerbations . Number of education sessions is four sessions on successive days in 1 hour.
Category
Lifestyle
2
Description
Group education depending on the number of people with Chronic obstructive pulmonary disease in research environments at the same time will receive education through group discussion in groups up to 8 to 10 people . Educational content includes self-management education for chronic obstructive pulmonary disease , which is composed of two components: stable chronic obstructive pulmonary disease self-management involves identifying and reducing risk factors , medication, non-pharmacological, monitoring and follow up and self-management in exacerbations . Number of education sessions is four sessions on successive days in 1 hour.
Category
Lifestyle
3
Description
The control patients will receive standard hospital care .
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Frashad Heidari Beni
Street address
Nurse st.
City
Shahrekord
2
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Frashad Heidari Beni
Street address
Nurse St.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Room #503, 5th floor, Central building of Iran University of Medical Sciences, between Chamran and Hemmat Expways, Hemmat Expway
City
Tehran
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farshad Heidari Beni
Position
Nursing Msc Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery , No 6 , Rashid Yasemi st , Vali-e-asr Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 1880
Fax
Email
Heidarifarshad70@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Forough Rafii
Position
PhD . Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Iran University of Medical Sciences , No 6 , Rashid Yasemi st , Vali-e-asr Ave , Tehran, Iran
City
Tehran
Postal code
1996713883
Phone
+98 21 8820 1880
Fax
Email
rafiee.f@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshad Heidari Beni
Position
Nursing Msc Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery , Iran University of Medical Sciences , No 6 , Rashid Yasemi st , Vali-e-asr Ave , Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8820 1880
Fax
Email
Heidarifarshad70@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)