General Objective: Determining the effect of telenursing on self-efficacy and health status of patients with chronic obstructive pulmonary disease
Design
The sampling method will be done in an accessible and block random allocation with random allocation software into two intervention and control groups. In order to conceal the random allocation process, the names of the groups are arranged in envelopes from 1 to 108.
Settings and conduct
This study will be conducted in one of the hospitals affiliated to Qazvin University of Medical Sciences and in hospitalized patients with chronic obstructive pulmonary disease.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1.Based on clinical records and medical records, the patient is a known case of chronic obstructive pulmonary disease.
2.Consent to participate in the study.
3.have access to mobile phones and common messengers.
4.The patient should not be completely unable to do personal affairs and take care of himself.
5.She/he does not suffer from a known mental illness and does not take psychoactive drugs.
6.Do not suffer from other chronic diseases such as brain, heart, kidney, cancer, etc.
Intervention groups
Pre-test in two intervention and control groups.Completing the questionnaires before the discharge of the patients and in the hospital.The beginning of the intervention, the first 2 sessions in the hospital and the next 6 sessions in the first 3 weeks after the discharge of the patients, 2 times a week with an interval of 3 to 4 days.The control group will receive the same routine training during hospitalization. and will be discharged from the hospital.Measuring self-efficacy and health status in both groups after the end of the training sessions, one and three months later
Main outcome variables
Chronic obstructive pulmonary disease - telenursing - self-efficacy - health status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231023059820N1
Registration date:2023-12-24, 1402/10/03
Registration timing:prospective
Last update:2023-12-24, 1402/10/03
Update count:0
Registration date
2023-12-24, 1402/10/03
Registrant information
Name
Shirin Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 4824
Email address
nrs.rajabi.sh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of telenursing on the self-efficacy and health status of patients with chronic obstructive pulmonary disease
Public title
The effect of telenursing on self-management of chronic obstructive pulmonary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A known case of chronic obstructive pulmonary disease.
Consent to participate in the study.
have access to mobile phones and common messengers.
Do not be completely unable to do personal affairs and take care of yourself.
Do not suffer from a known mental illness and does not take psychoactive drugs.
Do not suffer from other chronic diseases such as brain, heart, kidney, cancer, etc.
Exclusion criteria:
The patient's unwillingness to continue participating in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be divided into two test and control groups by block randomization. Blocking and sequencing of samples will be done with random allocation software ( Version 1.0.0). In order to conceal the random allocation process (allocation concealment), the names of the groups are placed in envelopes, these envelopes are numbered from 1 to 108 in the sequence provided by the software and arranged in a box. performs random allocation, the contents of the envelopes will not be in the flow, the contents of the envelopes indicate the study groups (test or control) and after making sure that the sample enters the research and obtaining written consent, the first envelope is taken in order of number and carefully According to the content of the envelope, they are placed in one of the study group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin - Shahid Bahonar Boulevard - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2023-07-05, 1402/04/14
Ethics committee reference number
IR.QUMS.REC.1402.085
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy of patients with chronic obstructive pulmonary disease
Timepoint
The beginning of the study (before the start of the intervention), immediately after the end of the training and 1 and 3 months after the end of the intervention
Method of measurement
Self-efficacy questionnaire in patients with chronic obstructive pulmonary disease
2
Description
health status of patients with chronic obstructive pulmonary disease
Timepoint
The beginning of the study (before the start of the intervention), immediately after the end of the training and 1 and 3 months after the end of the intervention
Method of measurement
Koop self-assessment questionnaire of health condition
Secondary outcomes
1
Description
Telenursing in patients with chronic obstructive pulmonary disease
Timepoint
In the first 3 weeks after the discharge of patients, it will be done twice a week with an interval of 3 to 4 days.
Method of measurement
Use of mobile phones and common messengers
Intervention groups
1
Description
Intervention group: In the intervention group, the educational needs of each patient will be identified. The educational needs of patients will be evaluated and determined according to various aspects of self-care in patients with COPD that are emphasized in reliable nursing sources. These aspects include twelve items, knowledge and awareness related to the anatomy and physiology of the lung, description of the disease, ways to treat the disease, how to comply with the prescribed drug regimen, nutrition, balance of daily activity and rest, exercise and physical activity, elimination of harmful habits such as Smoking, the skills of how to use the oxygen device, the skills of how to use inhalation sprays correctly, effective breathing methods, prevention of lung infection and how to do lung physiotherapy at home. In each training session based on the educational needs of the patient, part of the content of this The pamphlet will teach patients over the phone.
Category
Rehabilitation
2
Description
Control group:The control group will receive the same routine training during hospitalization and discharge from the hospital.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Shirin rajabi
Street address
Unit 3، No. 8، Jam 6 Alley، Abgine St.، Koi Kausar
City
Qazvin
Province
Qazvin
Postal code
3471637356
Phone
+98 912 780 8629
Email
Nrs.rajabi.sh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
shirin rajabi
Street address
Unit 3، No. 8، Jam 6 Alley، Abgine St.، Koi Kausar
City
Qazvin
Province
Qazvin
Postal code
3471637356
Phone
+98 912 780 8629
Email
Nrs.rajabi.sh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
1
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
Qazvin University of Medical Sciences
Full name of responsible person
Shirin Rajabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 3، Plate 8، 6 Jam Alley، Abgineh St.، Kosar Koi
City
Qazvin
Province
Qazvin
Postal code
3471637356
Phone
+98 28 3379 4824
Fax
Email
nrs.rajabi.sh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shirin Rajabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 3، Plate 8، 6 Jam Alley، Abgineh St.، Kosar Koi
City
Qazvin
Province
Qazvin
Postal code
3471637356
Phone
+98 28 3379 4824
Fax
Email
nrs.rajabi.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shirin Rajabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 3، Plate 8، 6 Jam Alley، Abgineh St.، Kosar Koi
City
Qazvin
Province
Qazvin
Postal code
3471637356
Phone
+98 28 3379 4824
Fax
Email
nrs.rajabi.sh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data including sex, age, history of disease will be printed in the article.
When the data will become available and for how long
The start of the access period is 6 months to one year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and graduate students
Under which criteria data/document could be used
Available in printed article.
From where data/document is obtainable
by Email
nrs.rajabi.sh@gmail.com
What processes are involved for a request to access data/document