Protocol summary

Summary
The purpose of this study is to determines the effect of self management program on indicators of clinical status in patients with chronic obstructive pulmonary disease . The 50 patients with COPD chosen for inclusion criteria: diagnosis COPD by physician; 45-70 years old; having literacy. Patients were randomly assigned into control and intervention group. Control group received usual care and intervention group received usual care plus intervention. Intervention contained self management program based on 5A model for 12 weeks in 5 steps: 1)Assess 2)Advise 3)Agree 4)Assist 5)Arrange. Patients who impossible Follow up were excluded. At baseline and the end of study fatigue, dyspnea, exercise tolerance and PFT were measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013061713694N1
Registration date: 2013-08-11, 1392/05/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Maryam Heidari
Name of organization / entity
Ahvaz Jondishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 2422
Email address
heidari.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ahvaz Jondishapur University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-05-15, 1392/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self management program on indicators of clinical status in patients with chronic obstructive pulmonary disease
Public title
The effect of self management program on indicators of clinical status in patients with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: COPD confirmed by physician; age between 45-70 years; having a BMI less than 30; understanding the Persian language; having literacy; absence of major psychiatric disorder; absence of other diseases such as neurological and musculoskeletal system disorders, cancer, not heart attack or angina attack in last month; having established a treatment plan. Exclusion criteria: Admission in hospital during of study; patient required to oxygen or spray during of six minute walking test; absence of patient in group educational session; impossibility for follow up.
Age
From 45 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
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
Ahvaz Ethics committee of Jondishapur University of Medical Sciences
Street address
Vice Chancellor for Research, Ahvaz Jondishapur University of Medical Sciences, Golestan Road, Ahvaz.
City
Ahvaz
Postal code
61357-15794
Approval date
2013-04-13, 1392/01/24
Ethics committee reference number
U-92015

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.9
ICD-10 code description
chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Dyspnea
Timepoint
befor the intervention, 12 weeks after intervention
Method of measurement
Borg Scale

2

Description
Exercise Tolerance
Timepoint
befor the intervention, 12 weeks after intervention
Method of measurement
Six Minutes Walking Test

3

Description
Pumonary Function
Timepoint
befor the intervention, 12 weeks after intervention
Method of measurement
Spirometery Test

4

Description
Fatigue
Timepoint
befor the intervention, 12 weeks after intervention
Method of measurement
Fatigue Sever Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Providing an educational pamphlet plus receive of self management program based on 5A model in the term of 12 weeks, in 5 stage: Assess, Advise, Agree, Assist, Arrange.
Category
Behavior

2

Description
Control Group: providing an educational pamphlet
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Respiratory Subspecialty Clinic
Full name of responsible person
Dr.Seyed Hamid Borsi
Street address
Apadana Specialty Clinic, East Esfand Street, Kianpars, Ahvaz.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Dr. Mostaffa Feghhi
Street address
Vice Chancellor for Research, Ahvaz Jondishapur University of Medical Sciences, Golestan Road, Ahvaz.
City
Ahvaz
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, Ahvaz Jondishapur 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
Ahvaz Jondishapor University of Medical Science
Full name of responsible person
Maryam Heidari
Position
Master Science In Nursing
Other areas of specialty/work
Street address
Nursing Dept, Ahvaz Jondishapur University of Medical Sciences, Golestan Road, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 1373 2422
Fax
Email
heidari.ma@ajums.ac.ir; heidari.maryam84@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapur University Medical of Sciences
Full name of responsible person
Sedigheh Fayazi
Position
Master Science In Nursing
Other areas of specialty/work
Street address
Nursing Dept, Ahvaz Jondishapur University of Medical Sciences, Golestan Road, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 1373 2422
Fax
Email
Sadighe_fa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapur University Medical of Sciences
Full name of responsible person
Maryam Heidari
Position
Master Science In Nursing
Other areas of specialty/work
Street address
Nursing Dept, Ahvaz Jondishpur University of Medical Sciences, Golestan Road, Ahvaz.
City
Ahvaz
Postal code
Phone
+98 61 1373 2422
Fax
Email
heidari.ma@ajums.ac.ir; heidari.maryam84@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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