Investigating the impact of continuous care model on lifestyle and self-care of patients with chronic obstructive pulmonary disease
Design
The clinical trial is a blind and has a control and intervention group for 70 patients. A table of random numbers was used for randomization.
Settings and conduct
The study is carried out in the respiratory departments of Amir al-Mominin Hospital in Zabul and then in the patients' homes. Initial sampling is done from the hospital departments, and if the patient is discharged, the follow-up is done at home, and the intervention is implemented for three months.
Participants/Inclusion and exclusion criteria
Over 40 years old
Suffering from chronic obstructive pulmonary disease, diagnosis confirmed by a specialist doctor
Availability of the patient for a period of 3 months and obtaining informed consent to participate in the study
Having a history of more than one year of illness
Being literate in reading and writing
Intervention groups
In this study, the continuous care model, which is an Iranian model, is implemented for three months in the intervention group, and the control group receives routine care.
Main outcome variables
lifestyle, self-care
General information
Reason for update
Acronym
chronic obstructive pulmonary disease(COPD)
IRCT registration information
IRCT registration number:IRCT20230711058740N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Tayebe Sargazi shad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 7998
Email address
t.sargazi.shad@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of continuous care model on lifestyle and self-care of patients with chronic obstructive pulmonary disease(COPD)
Public title
Investigating the impact of continuous care model on lifestyle and self-care of patients with chronic obstructive pulmonary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 40 years
Having chronic obstructive pulmonary disease and confirming diagnosis by a doctor
A history of more than one year of illness
Being literate in reading and writing
Availability of the patient for 3 months and obtaining informed consent to participate in the study
Exclusion criteria:
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After checking the conditions for entering the study and selecting the eligible patients, they are classified into two intervention and control groups using a random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
After checking the conditions for entering the study and obtaining informed consent, patients are classified into intervention and control groups using a random number table, and the participants do not know which group they are in, and the intervention group receives care related to the study. and the control group receives routine care.
Placebo
Not used
Assignment
Other
Other design features
After checking the conditions of entry into the study and obtaining informed consent, the patients are randomly divided into two intervention and control groups, and the intervention group receives the follow-up care model, and the control group receives routine care. Then the results of the two groups are compared.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zabul University of Medical Sciences
Street address
Deputy of research and technology; first floor., Zabul University of Medical Sciences educational complex., health intersection., Shahid Rajaee St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Approval date
2023-06-07, 1402/03/17
Ethics committee reference number
IR.ZBMU.REC.1402.047
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lifestyle
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Miller-Smith Lifestyle Questionnaire 1988
2
Description
Self care
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Miller 1982 self-care behavior questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The continuous care model is an Iranian model that is implemented for three months for the intervention group and includes three stages. In the first phase, one face-to-face training session every week for a month, and in the second phase, four calls per week for consultation and follow-up, and in the third phase, for a month, the patient implements the provided care and training, and if needed, in all The researcher will be contacted for consultation.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-Mominin Hospital, Zabul
Full name of responsible person
Dr. Abili
Street address
Respiratory department., Amiral Mominin hospital., Parastar St., Zabul city
City
زابل
Province
Sistan-va-Balouchestan
Postal code
9861979917
Phone
+98 54 3421 1300
Email
t.sargazishad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Hadi Mirzaei
Street address
Deputy of research and technology; first floor., Zabul University of Medical Sciences educational complex., health intersection., Shahid Rajaee St.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 0768
Email
pr@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
80
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
Zabol University of Medical Sciences
Full name of responsible person
Tayebe sargazi shad
Position
Lecturer of clinical education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
6th door on the left., 13th alley., South Imam Khomeini street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861868447
Phone
+98 54 3223 7998
Email
t.sargazishad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Tayebe sargazi shad
Position
Lecturer of clinical education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
6th door on the left., 13th alley., South Imam Khomeini street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861868447
Phone
+98 54 3223 7998
Email
t.sargazishad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Tayebe sargazi shad
Position
Lecturer of clinical education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
6th door on the left., 13th alley., South Imam Khomeini street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861868447
Phone
+98 54 3223 7998
Email
t.sargazishad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available