The effect of pulmonary rehabilitation application on care burden, psychological distress and quality of life of caregivers of patients with chronic obstructive pulmonary disease
Determining the effect of pulmonary rehabilitation application on care burden, psychological distress and quality of life of caregivers of patients with chronic obstructive pulmonary disease
Design
A clinical trial with a control group, with parallel groups, without blinding, randomized, on 70 observers. Randomization with Mineralization software.
Settings and conduct
Samples are selected at a comprehensive hospital respiration clinic in Isfahan, according to the criteria of entry. Then they are divided into two groups (intervention and control) with minimization software.The control group is also trained at the clinic.
Participants/Inclusion and exclusion criteria
1. age aged 18 - 60 for caregivers
2. Access to the Internet and smartphone
3. Lack of psychiatric disorders in caregivers and patients
4. Having a minimum reading and writing literacy among controllers
5. The primary responsibility for caring for the patient is by caregivers.
6. caregivers have a history of care more than 6 months
7.Patients are based on the global initiative scale of chronic lung obstruction (2 to 4 disease).
Non - entry conditions:
1.Lack of willingness to work in research
Intervention groups
This intervention includes a mobile-based pulmonary rehabilitation program that runs for 6 weeks. The application will include educational content in the pulmonary Rehabilitation area, the guide to using types of respiratory spray, Exercises improve lung function, question and response, ability to record sign, Relaxation and Send reminder messages.
Main outcome variables
Care burden; Quality of Life; Psychological distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161203031200N3
Registration date:2022-06-29, 1401/04/08
Registration timing:prospective
Last update:2022-06-29, 1401/04/08
Update count:0
Registration date
2022-06-29, 1401/04/08
Registrant information
Name
Vajihe Atashi
Name of organization / entity
Nursing Faculty of Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
vajiheatashi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pulmonary rehabilitation application on care burden, psychological distress and quality of life of caregivers of patients with chronic obstructive pulmonary disease
Public title
The effect of pulmonary rehabilitation application on caregivers of patients with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be in grades 2 to 4 on the Global Initiative Scale for Obstructive Pulmonary Disease.
Patients and caregivers have no history of cognitive or mental disorders.
The age category of caregivers is 18-60 years.
Caregivers have access to the Internet and smartphones to use the app.
The primary responsibility for patient care lies with the caregiver.
The caregiver has more than 6 months of patient care history.
Caregivers have a minimum reading literacy and Mobile literacy.
Exclusion criteria:
Samples are reluctant to participate in the study.
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Caregivers are selected according to the inclusion criteria by available sampling method and are divided into two groups of intervention and control by simple randomization method individually and based on mini-mining software. This software divides people into two groups during the study based on the background variables and the number required for each group. In order to conceal random allocation, the decision to accept or reject participation in the study was made from the beginning and the informed consent form was completed, and then participants were randomly assigned to each group.
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 Esfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hazar, Azadi Square. Jerib St,
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.152
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
Z82.5
ICD-10 code description
Family history of asthma and other chronic lower respiratory diseases
Primary outcomes
1
Description
The burden of care, quality of life and psychological distress
Timepoint
Measuring the burden of care, quality of life and psychological distress at the beginning of the study and 6 weeks after starting to use the pulmonary rehabilitation application
Method of measurement
Kessler Psychological Distress Questionnaire, Zarit Care Load Questionnaire, SF12 Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is a mobile-based pulmonary rehabilitation application that was prepared based on current world sources and approved by experts. This application has two main panels of patient management and education. Patient panel capabilities include educational content in the field of pulmonary rehabilitation in the form of video and text, guidance on the use of respiratory sprays, training in lung function-enhancing exercises, the ability to ask and answer questions, the ability to record symptoms daily, relaxation and daily reminder messages . This application will be provided to the intervention group for 6 weeks and the samples will be taught how to use it. After that, people can access educational content without any time limit by connecting to the Internet and through their mobile phones.
Category
Rehabilitation
2
Description
Control group: People in the control group are present to face - to - face lung rehabilitation training sessions. The pulmonary rehabilitation program provided for the patients involves a combination of lung performance enhancing exercises and providing the necessary training on the disease.People are trained in groups of five and are trained for two times a week. It goes on to train 12 sessions that will take about an hour each of the controllers training sessions.The training content included in the sessions included materials needed in the field of lung and rehabilitation.It is also called on to remind people twice a week to be involved in training sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khurshid hospital
Full name of responsible person
Vajihe Atashi
Street address
Khurshid Hospital, Governorate Street, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8177788153
Phone
+98 31 3303 3740
Email
nour@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Siavash Dastjerdi
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
siavash@med.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
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
Esfahan University of Medical Sciences
Full name of responsible person
Vajihe Atashi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square...
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
vajiheatashi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vajihe Atashi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 0048
Email
Vajiheatashi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vajihe Atashi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Azadi Square
City
Esfahan
Province
Isfehan
Postal code
73461 -81746
Phone
+98 31 3668 0048
Email
Vajiheatashi@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to ethical considerations, no publication takes place.