The effect of online group support on psychological distress and self-care behaviors of the elderly with type 2 diabetes during the COVID-19 pandemic: a parallel randomized clinical trial
Evaluation of the effect of online group support on psychological distress and self-care behaviors of the elderly with type 2 diabetes during the Covid-19 pandemic
Design
Parallel randomized superiority controlled trial, using a random blocking allocation that cannot be blinded and sample size will 90.
Settings and conduct
The research will be performed in Imam Hossein Clinic in Shahroud. Standard questionnaires of diabetes self-efficacy ccale and stress, anxiety and depression at the beginning and 7 days after intervention will be completed.
Participants/Inclusion and exclusion criteria
The patient's age is over 60 years; a definitive diagnosis of diabetes by a physician; the ability to access the Internet and online mass communication; has the minimum ability to use smartphones and social networks; absence of psychological disorders; Not participating in other supportive interventions.
Intervention groups
Intervention group: The intervention group received 6 sessions over 3 weeks are held in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. The outlines of the sessions include (diabetes education, diet, physical activity and medication in diabetes, stress education and its influencing factors, supporting older adults in identifying ineffective and stressful thoughts, providing solutions (problem-oriented and emotion-oriented) in dealing with stress, providing support in the application of the support provided in daily life.
Main outcome variables
Self-care; stress; anxiety; depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180728040617N4
Registration date:2022-12-12, 1401/09/21
Registration timing:prospective
Last update:2022-12-12, 1401/09/21
Update count:0
Registration date
2022-12-12, 1401/09/21
Registrant information
Name
Seyedmohammad Mirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 3811
Email address
mirhoseinim@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online group support on psychological distress and self-care behaviors of the elderly with type 2 diabetes during the COVID-19 pandemic: a parallel randomized clinical trial
Public title
The effect of online group support on psychological distress and self-care behaviors of the elderly with type 2 diabetes during the COVID-19 pandemic: a parallel randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age at least 15 years
The definitive diagnosis of diabetes has been made by a doctor
Smartphone access
Having minimum media literacy
Ability to access the Internet and online mass communication software.
No psychological disorders
Non-participation in other supportive interventions.
Exclusion criteria:
Do not participate in the post-test
Absence from more than two sessions in support sessions
Patient death during the study
Occurrence of stressful events (except for the usual treatment process) for the patient
Age
From 60 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
Patients will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 22. According to the sample size of 90 in the present study, 23 quadruple blocks will be considered. Each patient will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks.
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.SHMU.REC.1401.165
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Psychological distress
Timepoint
At the beginning of the study (before the intervention) and 7 days after intervention.
Method of measurement
Lovibond Depression, Anxiety and Stress Scale (DASS-21)
2
Description
Self care behaviors
Timepoint
At the beginning of the study (before the intervention) and 7 days after intervention.
Method of measurement
Toobert & Glasgow diabetes self care scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, 6 sessions will be held in 3 weeks for a duration of 60 minutes in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Supportive content in the educational field: (diabetes education, diet, physical activity and medication in diabetes) and in the psychological field of the stress management program according to the theoretical model of stress management by Lazarus and Folkman (1- stress education and factors affecting it 2- support older adults in identifying ineffective and stressful thoughts 3- Providing solutions (problem-oriented and emotion-oriented) in dealing with stress 4- Providing support in applying the support provided in daily life. Data collection tools include demographic information form, Lavibond anxiety and depression scale (DASS-21) and Tobert and Glasgow diabetes self-care which were administered by all patients before the intervention before the first session. (Intervention and Control Group), will be completed online. After 7 days from the end of the intervention sessions, the mentioned questionnaires will be completed to assess the effect of the intervention.
Category
Other
2
Description
Control group: They will receive routine support from the treatment centre. Supporting contents will be provided to the control group after the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Clinic
Full name of responsible person
Fateme Ebrahimiyan
Street address
Imam Hossein Hospital, Emam St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
ebrahimiyan.fateme@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Fateme Ebrahimiyan
Position
Bachelor in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahar Hospital, 22th Bahman St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
ebrahimiyan.fateme@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hossein Ebrahimi
Position
Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Email
ebrahimi@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyedmohammad Mirhosseini
Position
Instructor of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 3811
Email
mirhoseinim@shmu.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the patient's demographic information can be shared after unidentifying individuals. All of the patients' psychological distress and self care behaviors assessment information can be shared with caregivers after unidentified individuals.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Project partners
Under which criteria data/document could be used
People who do similar research
From where data/document is obtainable
It will be done by email with the person in charge of the project.
What processes are involved for a request to access data/document