The effect of pulmonary rehabilitation Mobile based application on quality of life, depression and Anxiety and activity daily living in patients Recovered of with Covid 19 undergoing pulmonary rehabilitation referred to the comprehensive respiratory clinic of Khorshid Hospital in 1400
Evaluation of the effect of mobile phone-based pulmonary rehabilitation software on quality of life, anxiety, depression and physical activity capacity in patients improved from Covid 19 under pulmonary rehabilitation
Design
A two-group clinical trial study with intervention and control groups with parallel groups that will be done by sampling the mini-mice program.
Settings and conduct
After confirming the research in the ethics committee and obtaining permission from the officials of Khorshid Hospital, patients will be divided into two groups of intervention and control with mini-miser software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Declaration of willingness to participate in the study by completing the informed consent form; Age category 18-60 years; Internet access and smartphones, minimum literacy; No vision or hearing problems; Be literate at least 21 days after the onset of symptoms in a patient with severe Quid 19.
Exclusion criteria: unwillingness to participate in the study; Participate in similar courses simultaneously; Conclusive evidence of venous and pulmonary embolism thrombosis; Acute symptoms of Covid 19 (temperature over 38 degrees ....); Systolic blood pressure less than 90, diastolic blood pressure less than 60; Systolic blood pressure above 140 and diastole above 90; History of ischemic or hemorrhagic stroke or neurodegenerative diseases; Major mental disorder according to psychiatrist; Any disorder in which the patient's mobility is active, patients with active cancer; Recipient of palliative care
Intervention groups
After explaining the goals and obtaining written informed consent, the relevant questionnaires (Bartel, Nosocomial Depression Anxiety, Quality of Life Questionnaire sf12) will be provided to the samples.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047029N2
Registration date:2022-03-07, 1400/12/16
Registration timing:registered_while_recruiting
Last update:2022-03-07, 1400/12/16
Update count:0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
Ramin Sami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2892
Email address
r.sami@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pulmonary rehabilitation Mobile based application on quality of life, depression and Anxiety and activity daily living in patients Recovered of with Covid 19 undergoing pulmonary rehabilitation referred to the comprehensive respiratory clinic of Khorshid Hospital in 1400
Public title
The effect of pulmonary rehabilitation Mobile base application
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Declare willingness to participate in the study by completing the informed consent form
Age category 18-60 years
Internet access and mobile phone to use mobile-based lung rehabilitation software
Have a minimum literacy
No vision or hearing problems
Have the literacy to use a mobile phone to work with mobile-based lung rehabilitation software
At least 21 days have elapsed since the onset of symptoms in patients with severe coronary artery disease.
Exclusion criteria:
Reluctance to participate in the study
Participate in similar courses simultaneously
Definitive evidence of venous and pulmonary thromboembolism
Acute symptoms of Covid 19 (temperature over 38 degrees ....)
Systolic blood pressure less than 90 mm Hg, diastolic blood pressure less than 60 mm Hg
Systolic blood pressure above 140 mm Hg and diastole above 90 mm Hg
History of heart disease class 4-2
Ischemic or hemorrhagic stroke or neurodegenerative diseases
Major mental disorder according to psychiatrist (schizophrenia, paranoid disorders and major depression)
Any disorder that restricts the patient's ability to move during pulmonary rehabilitation
Patients with active cancer
Patients receiving palliative care
Absence of more than 2 sessions in pulmonary rehabilitation training programs or failure to answer the researcher's call more than 2 times a week
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
In order to divide patients into two groups, they will be given mini-mapping software. Mini-magnification (or mini-magnifier) is the name of a software that is used to divide samples into groups in clinical trials. There are always variables in research projects that may affect the accuracy of the study (confounding variables); By entering these variables in this software, the variables are distributed among the research groups in such a way that there is the least difference between the groups, and therefore this method is preferable to the randomization method. Sampling process until the number Research units will continue to reach the desired number.
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
Ethics committee of isfahan University of Medical Sciences
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.ARI.MUI.REC.1400.105
Health conditions studied
1
Description of health condition studied
covid 19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Quality of Life
Timepoint
6 months
Method of measurement
SF-12 Quality of Life Questionnaire, HADS Hospital Anxiety and Depression Scale, Bartel Scale
Secondary outcomes
1
Description
Stress and depression
Timepoint
6 months
Method of measurement
Anxiety and Depression Clinical Scale Questionnaire(HADS)
2
Description
Fasting days of life
Timepoint
6 months
Method of measurement
Bartel Questionnaire
Intervention groups
1
Description
In the intervention group (mobile-based pulmonary rehabilitation software) after completing the questionnaires as a pre-test, a briefing session will be held by a specialist nurse on how to work with the software for them and then the educational content of how Patient care will be installed in the same content as the face-to-face training group in the form of software that can be installed on the Android operating system on patients' mobile phones or tablets. This software consists of different parts, the first part includes the management of software users, where it is possible to insert and edit patient information from the management and the possibility of entering personal information through the software.The second part includes educational content. The educational content in the software is similar to the face-to-face training group. The third part includes sending notifications to all users and the last part is the possibility of talking to the patient and caregiver with an online counselor. An online counselor in this plan is someone who is available to patients around the clock, who in the software discussion section, any questions and ambiguities about working with the program or educational content, any emergency or non-emergency counseling related to The condition of patients and ... responds.
Category
Rehabilitation
2
Description
Control group: The control group in the face-to-face training session of patients, educational content according to the needs of patients in groups of 5 people in 12 sessions that will last twice a week and each session will last 1 to 3 hours.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
khorshid medical educational research complex
Full name of responsible person
Mohsen Forghani
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۵۸۳۱۴۵۱
Phone
+98 31 3224 5681
Fax
Email
nour@mui.ac.ir
Web page address
http://nour.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kamal Heidari
Street address
Hezajarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
khabarnameh@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Sami
Position
Faculty
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
r.sami@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Sami
Position
faculty
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 322 1022
Email
r.sami@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ramin Sami
Position
faculty
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 322 1022
Email
r.sami@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available