Protocol summary

Summary
The aim of this study is to evaluate the effect of Orem self-care nursing model on activities of daily living of chronic obstructive pulmonary diseases patients. This randomized clinical trial performed on two groups of patients that matched with inclusion criteria, like lack of mental illnesses, no drugs or psychotropic abuse and age range between 40 to 65 years. Exclusion criteria includes some conditions like non-participation in more than half of classes; not having access to a phone call with patient and family during the study; death due to illness or other events. Each group consisted of 30 patients, and after sampling, patients were randomly placed in one of the two groups of case and control. Need assessments according to Orem model, Demographic questionnaire and self-made activities of daily living for chronic obstructive pulmonary disease patients questionnaire were filled by the two groups, before the intervention. 6 to 8 training meetings according to Orem self-care nursing model were held for the intervention group and after that they were followed up for 45 days. No specific interventions were taken on the control group. after the intervention, activities of daily living for chronic obstructive pulmonary disease patients questionnaires were completed again by two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081729411N1
Registration date: 2016-09-16, 1395/06/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-16, 1395/06/26
Registrant information
Name
Belal Babakhani
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 4622 2669
Email address
babakhani.b@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Orem self-care model application on activities of daily living status of chronic obstructive pulmonary disease patients hospitalized in education and treating centers of Urmia University of Medical Sciences in 2016
Public title
The effect of self-care education on activities of daily living status of chronic obstructive pulmonary disease patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age 40 to 65 year; Capable of reading and writing; Lack of mental illnesses; Residence in Urmia; Lack of cognitive, hearing, and vision impairment; Lack of education and employment in the medical group; lack of formal education about the disease; Having the ability and desire to participate in the study; Fluent in Persian language; capable of phone call comunicate; No drugs or psychotropic abuse; Specified Chronic obstructive pulmonary disease Exclusion criteria: non-participation in more than half of classes; Not having access to a phone call with patient and family during the study; Not intrested to continue the participation in the study; Death due to illness or other events
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Orjans Alley, Resalat Street
City
Urmia
Postal code
Approval date
2016-02-04, 1394/11/15
Ethics committee reference number
IR.UMSU.REC.1395.16

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary diseases
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Activities of daily living
Timepoint
1 month before the intervention and 45 days after the intervention
Method of measurement
Chronic obstructive pulmonary disease Activities of daily living questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Two 1.5-hour lecture meetings in groups of 5-6 patient to explain a full definition of COPD, symptoms, risk groups, risk factors, methods of treatment, prevention and pulmonary rehabilitation were held. data were analyzed by SPSS software.
Category
Lifestyle

2

Description
Intervention group: 6-8 meetings were held and divided by 5 steps: 1. Determine educational needs of patients self-care (According to Orem's need assessment model). 2. Application of self-care program in physical domain. 3. Application of mental and emotional self-care program domains. 4. Application of self-care program in social domain. 5. In final step of self-care program, the strengths and weaknesses of the program, new solutions and proper ways to implement the best solution to enhance the best self-care program to patients and their families has been described. Follow up: Self-care program was conducted by patients in 45 days. the questionnaire was given to patients to fill out for the second time after the intervention.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Iraj Mohebbi
Street address
Shahrchayi, Kashani Street
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Hossein Habibzadeh
Street address
Urmia University of Medical Sciences, Orjans valley, Resalat boulevard
City
Urmia
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, Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebi
Position
Vice Chancellor for Research, Urmia University of Medical Sciences
Other areas of specialty/work
Street address
Shahrchayi, Kashani Street
City
Urmia
Postal code
Phone
+98 44 3344 4591
Fax
Email
babakhani.b@umsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Scienses
Full name of responsible person
Belal Babakhani
Position
MSc Student of Nursery
Other areas of specialty/work
Street address
Halaniye 9 Alley, Moallem Street
City
Javanroud
Postal code
Phone
+98 83 4622 2669
Fax
Email
babakhani.b@umsu.ac.ir, b.babakhani1007@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Scienses
Full name of responsible person
Iraj Mohebi
Position
Associate Professor
Other areas of specialty/work
Street address
Shahrchayi, Kashani Street
City
Urmia
Postal code
Phone
+98 44 3344 4591
Fax
Email
bababkhani.b@umsu.ac.ir
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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