Determining the relationship between augmented reality-based training and adherence to treatment in respiratory patients
Design
Clinical trial with a control group, with factorial groups, without blinding, phase 2 on 80 patients. A table of random numbers was used for randomization.
Settings and conduct
This study is a randomized controlled trial based on a pre-test-post-test design with a control group. The sample size is 80 patients who refer to Imam Ali clinic in Kurd city, who are randomly divided into two groups of 40 people, intervention and control.
The control group receives the routine training and the intervention group receives the produced content in addition to the routine training.
Then, after one month, the two groups will be examined in terms of treatment, patient satisfaction, hospitalization rate, disease recurrence rate, patient stress and anxiety rate, and reduction in material costs.
Participants/Inclusion and exclusion criteria
inclusion criteria: consent to participate in the research, necessary cooperation, having a smartphone
exclusion criteria: not agreeing to participate in the study
Intervention groups
Intervention group: recipient of augmented reality training
Control group: did not receive the above intervention
Main outcome variables
Hospitalization frequency; severity of symptoms; response to treatment; health problems
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220711055436N1
Registration date:2022-08-16, 1401/05/25
Registration timing:prospective
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
hamid rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3765 2083
Email address
st-rajabi.h@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of training based on augmented reality in compliance with treatment in respiratory patients
Public title
Investigation of training based on augmented reality in compliance with treatment in respiratory patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
respiratory patients
over 18 years old
performing the necessary cooperation
Having a smartphone
having consent to participate in the research
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done individually using a table of random numbers.
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 Shahr kord University of Medical Sciences
Street address
kashani Blvd
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2021-12-22, 1400/10/01
Ethics committee reference number
ir.skums.rec.1400.202
Health conditions studied
1
Description of health condition studied
athma
ICD-10 code
J45
ICD-10 code description
Asthma
2
Description of health condition studied
copd
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Adherence to treatment
Timepoint
The time periods of measuring adherence to treatment before the start of the intervention and one month after the start of the intervention
Method of measurement
Measurement of medication adherence using Morisky Medication Adherence Scale, eight-option version (MMAS-8).
2
Description
respiratory health quality
Timepoint
Measurement periods before the start of the intervention and one month after the start of the intervention
Method of measurement
SGRQ scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: recipient of routine training plus training based on augmented reality. In this study, in order to design the educational content of a group consisting of lung disease specialists, nurses, e-learning group and medical education, medical students who are fully familiar with content creation software were used to familiarize themselves with the educational needs of patients. It is designed from DEVAR software and other software approved by the team
Category
Behavior
2
Description
Control group: recipient of routine training without training based on augmented reality.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali (A.S.) Specialized Clinic
Full name of responsible person
Hamid Rajabi
Street address
Shariati Blvd
City
Shahr Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3224 2696
Email
St-rajabi.h@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoume Moezzi
Street address
Shahrekord unevirsity of medical scinece, Rahmatiye Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88155571
Phone
+98 31 3765 2083
Email
St-rajabi.h@skums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamid Rajabi
Position
General medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Qasr dead end, Ferdowsi Quay, 35 Alley, Ashrafi esfahani Ave
City
isfahan
Province
Isfehan
Postal code
8187743895
Phone
+98 31 3765 2083
Email
St-rajabi.h@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamid Rajabi
Position
General medical student
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Qasr dead end, Ferdowsi Quay, 35 Alley, Ashrafi esfahani Ave
City
isfahan
Province
Isfehan
Postal code
8187743895
Phone
+98 31 3765 2083
Email
St-rajabi.h@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hamid Rajabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Qasr dead end, Ferdowsi Quay, 35 Alley, Ashrafi esfahani Ave
City
Isfahan
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8187743895
Phone
+98 31 3765 2083
Fax
Email
st-rajabi.h@skums.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
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available