Comparison of the effect of self-care education with two methods smartphone app and Teach Back methods on the lifestyle and quality of life of patients with inflammatory bowel disease
Comparison of the effect of self-care education with two methods smartphone app and Teach Back methods on the lifestyle and quality of life of patients with inflammatory bowel disease
Design
A three-group randomized clinical trial with a control group, with parallel groups, randomized by block, on inflammatory bowel patients, 90 patients
Settings and conduct
This study will include all patients with inflammatory bowel disease referred to the inflammatory bowel disease clinic of Ghaem Hospital and a gastroenterologist's clinic in Mashhad. Participants will be randomly assigned to three groups (two intervention groups and one control group) based on Inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years-
Have Literacy for reading and writing to complete the questionnaire-
Diagnosis by a specialist physician-
Having a smartphone (For app group)-
Ability to use smartphone apps(For app group)-
Patients with at least 6 months of disease diagnosis-
Not having other chronic illness with a doctor's diagnosis
Not having mental illness illness with a doctor's diagnosis
Exclusion criteria:
The Occurrence of surgical procedure (maximum one month before post-test)
The occurrence of specific medical conditions-
Lack of willingness to continue participating in the study-
Intervention groups
Teach back group (Content will be taught to patients in 2 sessions (2 days) for 45 minutes. The training package will finally be provided to the patient within 7 days. The interval between training sessions will be 1-3 days.)
App group: The app will be installed in a 30-minute session for patients, and they will be explained how to use the app.
Main outcome variables
Quality of life - lifestyle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045251N1
Registration date:2020-08-30, 1399/06/09
Registration timing:registered_while_recruiting
Last update:2020-08-30, 1399/06/09
Update count:0
Registration date
2020-08-30, 1399/06/09
Registrant information
Name
Mohamad hossein Mafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 2208
Email address
mafimh971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of self-care education with two methods smartphone app and Teach Back methods on the lifestyle and quality of life of patients with inflammatory bowel disease
Public title
Effect of self-care education on the lifestyle and quality of life of patients with inflammatory bowel disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Have Literacy for reading and writing to complete the questionnaire
Diagnosis by a specialist physician
Having a smartphone
Ability to use smartphone apps
Patients with at least 6 months of disease diagnosis
Not having other chronic illness with a doctor's diagnosis
Not having mental illness illness with a doctor's diagnosis
Exclusion criteria:
Lack of willingness to continue participating in the study
The occurrence of special medical conditions (leads to hospitalization of the patient)
Occurrence of surgical procedure (maximum one month before post-test)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: is block.
Random unit: is individual.
Randomization tool in study: statistical software SPSS.
Randomization sequence of randomization software: Randomization software for sequencing people in blocks and drawing lots for the order of the blocks themselves.
Allocation concealment method: The sequence created by randomization in opaque envelopes is closed.
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 Mashhad University of Medical Sciences
Street address
University Ave, Next to the Hoveyzeh Cinema, Ghorashi building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-10-12, 1398/07/20
Ethics committee reference number
IR.MUMS.REC.1398.200
Health conditions studied
1
Description of health condition studied
Crohn disease
ICD-10 code
K50
ICD-10 code description
Crohn's disease [regional enteritis]
2
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Quality of Life
Timepoint
Before and one month after the intervention
Method of measurement
Crohn’s and ulcerative colitis questionnaire (CUCQ)
2
Description
life style
Timepoint
Before and one month after the intervention
Method of measurement
Miller-Smith questionnaire
Secondary outcomes
1
Description
Illness severity
Timepoint
Before the intervention, one month after the intervention
Method of measurement
questionnaire (Crohn's Disease Activity Index (CDAI), Ulcerative Colitis Activity Index (UCAI))
2
Description
Recurrence and remission of the disease
Timepoint
Before the intervention, one month after the interventio
Method of measurement
questionnaire (Crohn's Disease Activity Index (CDAI), Ulcerative Colitis Activity Index (UCAI))
Intervention groups
1
Description
The first Intervention group (Application group): In this group, self-care training will be provided to patients by the smartphone application. The content of the app will include (nutrition and diet, medication diet, sleep and rest, activity and exercise, smoking, social relations, sex and pregnancy, treatment follow-ups and periodic monitoring, vaccinations). The app will be provided to the patient for free and then after a month, a post-test will be taken from the patient. The patient will be contacted every 10 days to express their problems about using the app.
Category
Behavior
2
Description
Second intervention group (Teach back group): In this group, self-care training in two face-to-face sessions will be provided to patients individually. There will be two sessions a week. The interval between sessions is between 1 and 3 days.
Category
Behavior
3
Description
Control group: In this group, self-care training will not be provided to patients.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital, Inflammatory bowel disease clinic
Full name of responsible person
Mohamad Hossein Mafi
Street address
Ahmadabad Ave, Dr. Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
2
Recruitment center
Name of recruitment center
Dr. Hassan Vossoughinia's clinic
Full name of responsible person
Mohamad Hossein Mafi
Street address
No 20, Negin Sajjad building, Between Khayyam crossroads and Golriz crossroads, Sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
---------
Phone
+98 51 3760 1818
Email
VosoghiniaH@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Saeid Eslami Hasanabadi
Street address
Knowledge and Health City, In the end of Shahid Fakouri Blvd (In front of Fakouri 94)
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3841 2081
Email
p.relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Hossein Mafi
Position
MSc. Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Ave, Doctora Crossroads, University Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
mafi1404@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Sadat Manzari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Ave, doctora Crossroads, University Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ManzariZ@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohamad Hossein Mafi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University Street, Doctora Crossroads ,Ebn'e Sina Street, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 901 555 4532
Email
mafi1404@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data is published as the main results.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Researchers who are researching in this field (inflammatory bowel disease).
Under which criteria data/document could be used
Analysis of main variables
From where data/document is obtainable
Researcher email
What processes are involved for a request to access data/document
The data will be provided to the applicants after 1 month.