Determining the effect of mobile learning on stress and self-efficacy in people with covid-19 diabetes
Design
A randomized clinical trial, single blinded, with a parallel group design of 70 patients
Settings and conduct
After receiving ethic code & IRCT code; a master list will be provided from Tehran university affiliated hospitals with the most admission of patient with covid-19. Patients will be divided into control and intervention groups by blocking randomization method. This intervention is a single blind one. Informed consent to participate in the study & questionnaires(demographic questionnaire, perceived Stress questionnaire & self- efficacy in diabetes questionnaire)will be completed by telephone call. Intervention ends in 3 months.
Participants/Inclusion and exclusion criteria
1. Diagnosis of type one or type two diabetes by specialist
2. Detection of covid-19 based on positive PCR test
3. Age range 18-65 year old
4. Basic literacy(able to read and write)
5. Having mobile phone
6. Living in Tehran;
1. Having any disease that interferes with the research process like psychological problems, stroke, heart attack, ketoacidosis
2. Re-infection by covid-19
Intervention groups
During three months, each week between 8 and 12 AM , three educational content including motivational items, daily care, healthy lifestyle, warning signs or complications about covid-19 and diabetes will be provided based on the preferred method (SMS or Call). Control group will not receive any educational content , except for the welcome SMS, and they will receive a phone call once a month just not to lose samples. At the end of the intervention, in order to observe the ethics in the research, the presented content will be provided to the control group in the form of a CD.
Main outcome variables
1. stress
2.self-efficacy in diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210302050555N1
Registration date:2021-03-28, 1400/01/08
Registration timing:prospective
Last update:2021-03-28, 1400/01/08
Update count:0
Registration date
2021-03-28, 1400/01/08
Registrant information
Name
Sara Abbasian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 3661
Email address
s-abbasian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of mobile-learning on stress and self-efficacy among diabetes patients with covid-19
Public title
The Effect of mobile-learning on stress and self-efficacy among diabetes patients with covid-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type one or type two diabetes by a specialist.
Detection of covid-19 based on positive PCR test.
Age range 18-65 year old.
Basic literacy(able to read and write).
Having mobile phone.
Living in Tehran.
Exclusion criteria:
Having any disease that interfere with the research process like psychological problems, stroke, heart attack, ketoacidosis.
Re-infection by covid-19.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking randomization
First, I go to the hospitals with an official introduction letter. A master list of all eligible people will be prepared and will be placed in the intervention and control group by blocking randomization method. Based on the results of studies, the number of required samples in each group is equal to 31 people in each group; taking into account of the 10% drop, the final number of required samples in each group is equal to 35. Total of 70 diabetic people with Covid-19 are determined are allocated by block randomization method into intervention and control groups. In the present study, the number of blocks will be 4 blocks. The adequacy of the number of samples in the early stages of this study is re-evaluated.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single blind research.
After explanation and clarification all steps to participants and obtaining written consent; the study will be started.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Nursing and midwifery department of Tehran University of Medical Science, Nosrat St., Enqelab Sq., Tehran,
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.TUMS.FNM.REC.1399.230
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.2
ICD-10 code description
COVID19, virus not identified
2
Description of health condition studied
diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
stress.
Timepoint
measuring stress level will be done before the intervention & 3 months after beginning of the intervention.
Method of measurement
Cohen's perceived stress questionnaire
2
Description
Self-efficacy in diabetes
Timepoint
measuring self-efficacy level will be done before the intervention & 3 months after beginning of the intervention.
Method of measurement
Diabetes self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, perceived stress questionnaire and diabetes self-efficacy questionnaire) by phone call; During three months, three educational contents per week between 8 and 12 AM, including motivational items, daily care, healthy lifestyle, nutrition, exercise, warning signs or complications about covid-19 and diabetes will be provided based on the preferred method of each (Phone call or text message). At the end of the intervention, the questionnaires will be completed again by phone call.
Category
Rehabilitation
2
Description
Control group: After completing the informed consent form to participate in the study and completing the desired questionnaires (demographic information questionnaire, perceived stress questionnaire and diabetes self-efficacy questionnaire) by phone cal; Welcome and study entry SMS will send to control group. During three months, in the first week of each month, they recieve phone call in order to greet and not to lose samples. At the end of the intervention, in order to observe the ethics in the research, the presented content will be provided to the control group in the form of a CD.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Sara Abbasian
Street address
Baharloo hospital, Behdari Ave., Rahahan Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1339735382
Phone
+98 21 5565 8500
Email
baharloo@sina.tums.ac.ir
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Sara Abbasian
Street address
Shariati hospital, North kargar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
3
Recruitment center
Name of recruitment center
Imam Khomeini Hospital complex
Full name of responsible person
Sara Abbasian
Street address
Imam Khomeini Hospital complex, Dr. Gharib Ave., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6698 2933
Email
Imamhospital@tums.ac.ir
4
Recruitment center
Name of recruitment center
Yas hospital complex
Full name of responsible person
Sara Abbasian
Street address
Yas hospital complex, North Prof.Nejatollahi Ave., Karimkhanzand St., Tehran
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Email
yashospital@gmail.com
5
Recruitment center
Name of recruitment center
Ziaeean Hospital
Full name of responsible person
Sara Abbasian
Street address
Ziaeean Hospital, Aboozar Ave., Qazvin St., Tehran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6814
Email
ziaeian@tums.ac.ir
6
Recruitment center
Name of recruitment center
Amiralam Hospital complex
Full name of responsible person
Sara Abbasian
Street address
Amiralam Hospital complex, Sadi Ave., Enqelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1744793779
Phone
+98 21 6670 6106
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor.mohammadali sahraian
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital Tehran – Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6670 6142
Email
Sahraian1350@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sara Abbasian
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.9, Ashkshahr St., Jahanara Ave., Yousefabad
City
Tehran
Province
Tehran
Postal code
1438913118
Phone
+98 21 8800 3661
Fax
Email
s-abbasian@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Abbasian
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.9, Ashkshahr St., Jahanara Ave., Yousefabad
City
Tehran
Province
Tehran
Postal code
1438913118
Phone
+98 21 8800 3661
Fax
Email
s-abbasian@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Abbasian
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.9, Ashkshahr St., Jahanara Ave., Yousefabad
City
Tehran
Province
Tehran
Postal code
1438913118
Phone
+98 21 8800 3661
Fax
Email
s-abbasian@razi.tums.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