To determine the effect of using the contentious care model on the self-efficacy of patients with COPD
Design
Randomized double blind clinical trial with control group and parallel group design, on 84 patients. For randomization, Randomizer will be used.
Settings and conduct
Research environment: Internal ward of all educational and medical centers of Gorgan, includes 5Azar and Sayyad Medical and Educational Centers; Study population: All patients with chronic obstructive pulmonary disease; Type of blinding: Double blind; Method of blinding: Blinding will be done for patients. Also the researcher and the outcome assessor will be also unaware of the allocation of patients into the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Able to write and read; ability to communicate; confirmation of the diagnosis of COPD by a physician; ability to perform the daily activities؛ history of hospitalization at least once with a diagnosis of COPD; having a smart phone.
Non-inclusion criteria: Having malignant disease and psychiatric disorders; history of participating in educational program with similar content
Intervention groups
Intervention group: Patients with chronic obstructive pulmonary disease under follow-up care;
Control group: Patients with chronic obstructive pulmonary disease under routine care
Main outcome variables
Self-Efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140412017237N13
Registration date:2021-09-24, 1400/07/02
Registration timing:registered_while_recruiting
Last update:2021-09-24, 1400/07/02
Update count:0
Registration date
2021-09-24, 1400/07/02
Registrant information
Name
Mahnaz Modanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3245 6900
Email address
modanloo.mahnaz@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of continuous care model and routine care on self-efficacy of patients with chronic obstructive pulmonary disease
Public title
Continuous care and self-efficacy of patients with COPD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to write and read
Ability to communicate
Ability to perform the daily activities
Having a smart phone
Obtaining low and medium scores from the self-efficacy questionnaire
Exclusion criteria:
Lack of known psychiatric disorder
History of participation in an educational course with the same content
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
By referring to the Randomization.com website and using the block randomization method (block of size 4), a list of random numbers is produced by one of the members of the research team who will not aware of the process of entering the groups (sample size of 84 people, in two groups A - B). Then the letters A and B will be written on the cards and placed in the sequentially numbered, sealed, opaque envelopes (1 to 84). After checking the inclusion criteria, the participants will receive the relevant envelope, respectively, and they will be allocated into two intervention (A) and control (B) groups according to the card in the envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind trial. Blinding will be done for patients. Also the researcher and the outcome assessor will be also unaware of the allocation of patients into the groups.
In this study for random sequence generation, 84 eligible patients will be recruit using Permuted Block Randomization (25 blocks of size 4) through Randomization.com. in order to conceal of sequence of randomization, based on a created list, A (for intervention group) and B (for control group) letter will be written on cards and the they will put in the sequentially numbered, sealed, opaque envelopes. Then the envelopes will be numbered from 1 to 84 and will consider for eligible patients sequentially that they will be close till applying intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard
Before intervention, immediately after intervention and one months after intervention
Method of measurement
COPD Self-Efficacy Scale
Secondary outcomes
1
Description
Number of rehospitalization
Timepoint
Record the number of readmissions of patients two and three months after discharge
Method of measurement
Patient clinical information registration form
Intervention groups
1
Description
Intervention group: The patients in intervention group will access to the Link of educational content in the developed site. The educational content consists of a lung rehabilitation program for patients with chronic obstructive pulmonary disease that will be implemented face-to-face for 2 months based on 4 steps of continuous care model including Orientation, Sensitization, Control and Evaluation. The follow up will be done weekly for 5 weeks.
Category
Behavior
2
Description
Control group: Patients in control group will receive routine care without any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar Medical and Educational Center
Full name of responsible person
Ali Ariannia
Street address
6th Azar, 5 Azar Street, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Fax
+98 17 3222 8363
Email
ariannia@goums.ac.ir
Web page address
http://goums.ac.ir
2
Recruitment center
Name of recruitment center
Sayyad Medical and Educational Center
Full name of responsible person
Alireza Norouzi
Street address
Sayad Shirazi St.
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3226 1175
Email
sayad@goums.ac.ir
Web page address
http://goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahnaz Modanloo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Nursing Research Center, Golestan University of Medical Sciences, Hirkan Boulevard
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
modanloo.mahnaz@goums.ac.ir
Web page address
http://goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Shahab Eskandari nezhad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, Faculty of Medicine, Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3222 0561
Fax
+98 17 3245 2225
Email
dr.eskandari@goums.ac.ir
Web page address
http://goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahsa Mehdizadeh
Position
Ms Student of Critical Nursing Care
Latest degree
Bachelor
Other areas of specialty/work
Critical Care Nursing
Street address
Faculty of Nursing and Midwifery, Golestan University of Medical Sciences, Hirkan Boulevard, Gorgan
City
Gorgan
Province
Golestan
Postal code
4917136536
Phone
+98 17 3245 6900
Fax
+98 17 3245 5171
Email
mahsamahdizadeh1398@gmail.com
Web page address
http://goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All collected deidentified IPD will be shared.
When the data will become available and for how long
6 months after publication the data files will be available.
To whom data/document is available
The data will be shared for people working in academic institutions.
Under which criteria data/document could be used
Meta analyses on data is permitted.
From where data/document is obtainable
Please contact to person responsible for scientific inquiries.
What processes are involved for a request to access data/document
The data will be available through email.
Comments
Please contact to both email address:
modanloo.mahnaz@goums.ac.ir
modanloo.mahnaz@gmail.com