Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001672842
Ethics application status
Approved
Date submitted
16/03/2021
Date registered
7/12/2021
Date last updated
28/11/2022
Date data sharing statement initially provided
7/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a diabetic self-management education intervention through WhatsApp for people with type 2 diabetes: A randomised controlled feasibility study
Scientific title
Effectiveness of a diabetic self-management education intervention through WhatsApp on HbA1C and diabetic knowledge for people with type 2 diabetes
Secondary ID [1] 303409 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 320697 0
Condition category
Condition code
Metabolic and Endocrine 318543 318543 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Participants assigned to WhatsApp group they will be join in a WhatsApp group via WhatsApp link and they will receive diabetic education sessions via WhatsApp. Each week will have a specific theme. Text information post and photos will be sent to the WhatsApp group each week. Videos will be delivered which related to DM information, the benefit of exercise, healthy food, and foot care. The education session will not be long and will take a 1 hour each week to go through all materials. Whatsapp allows you to see who viewed your content. Participants not engaging with the content in the WhatsApp group will be encouraged to do so through text messages. The student researcher will send also a reminder to all participants on Wednesday during the duration of the program. Participants are encouraged to spend time reading and interacting with the intervention every week The table below summarizes educational content. The educational materials will be developed and designed specifically for this study based on the results of our qualitative study based on current material from study venue (Ministry of health (MOH),2021), literature review(Alanzi et al., 2018; Petrovski & Zivkovic, 2019), International Diabetic Guidelines (Association of diabetes care & education specialist (ADCES),American Association of Diabetes Educators, 2020; 2021). If the participants assigned into control group they will receive the usual care provided in the health facility as per MOH guidelines in Saudi Arabia and diabetes education as per their needs.
A brief summary of the educational content
Session Proposed contents of DSME Mode of delivery
Week 1 • Welcome and orientation of the DSME intervention.
• What is DM and the importance of self-management?
• What is self-management and its technique?
• Discuss the experience with goal setting and action plan.
• WhatsApp posts
• Sharing experience
• Video on DM
• Questions and discussion
Week 2 • What problems do you have because of your diabetes?
• WhatsApp posts
• Sharing experience
• Questions and discussion
Week 3 • Discuss the importance of foot care.
• Discus how to do foot assessment. • WhatsApp post
• Video demonstration on foot care
• Sharing experience
• Questions and discussion
Week 4 • What is healthy food?
• How to manage your diet? • WhatsApp posts
• Sharing Experience
• Video on how to manage your diet
• Questions and discussion
Week 5 • What is the benefit of exercise?
• What exercise would be beneficial for you?
• WhatsApp posts
• Sharing Experience
• Video demonstration on exercise
• Questions and discussion
Week 6 • Reducing risk and coping with diabetes. • WhatsApp posts
• Sharing Experience
• Concluding the intervention
• Questions and discussion

Reference
References

Alanzi, T., Bah, S., Alzahrani, S., Alshammari, S., & Almunsef, F. (2018). Evaluation of a mobile social networking application for improving diabetes Type 2 knowledge: an intervention study using WhatsApp. Journal of comparative effectiveness research, 7(09), 891-899.

Association of diabetes care & education specialist. (2021). Resources for People Living with Diabetes. https://www.diabeteseducator.org/living-with-diabetes/Tools-and-Resources

Ministry Of Health. (2021). healthy lifestyle https://www.moh.gov.sa/awarenessplateform/HealthyLifestyle/Pages/default.aspx

Petrovski, G., & Zivkovic, M. (2019). Are we ready to treat our diabetes patients using social media? Yes, we are. Journal of diabetes science and technology, 13(2), 171-175.
Intervention code [1] 319712 0
Treatment: Other
Comparator / control treatment
For the purpose of the present study, the "usual case" is defined as the medical treatment for participants who receive services within the Jazan Diabetic Centre, such as regular visits to diabetologists and testing for blood glucose levels in conjunction with visits to diabetic educators based on the patient’s needs. The usual medical treatment will be provided in accordance with MOH guidelines in Kingdom of Saudi Arabia (KSA)
Control group
Active

Outcomes
Primary outcome [1] 326501 0
Self-efficacy assessed by using UK-Diabetic Management Self-Efficacy Scale (UK-DMSES)'
Timepoint [1] 326501 0
UK-DMSES will assessed at baseline, immediately post-intervention (at 8th week), and 3 months post-intervention completion
Primary outcome [2] 328264 0
Diabetic knowledge assessed by using Diabetic Knowledge Test (DKT)
Timepoint [2] 328264 0
DKT will assessed at baseline, immediately post-intervention (at 8th week ), and 3 months post-intervention completion
Secondary outcome [1] 391753 0
HbA1c assessed by blood test
Timepoint [1] 391753 0
HbA1c will assessed at baseline, immediately post-intervention (at 8th week), and 3 months post-intervention completion.
Secondary outcome [2] 398271 0
Anxiety and Depression assessed by using Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 398271 0
HADS will assessed at baseline, immediately post-intervention (at 8th week ), and 3 months post-intervention completion
Secondary outcome [3] 398272 0
Quality of life assessed by using Diabetes Management Quality of Life (DMQOL)
Timepoint [3] 398272 0
DMQOL will assessed at baseline, immediately post-intervention (at 8th week ), and 3 months post-intervention completion

Eligibility
Key inclusion criteria
• Males or females diagnosed with T2DM and regularly followed up at the diabetic centres.
• Male or female aged 18 to 60 years old.
• HbA1C greater than 9 % (Universally considered poor control)
• Patients are willing to participate in the study and have the capacity to provide informed consent.
• Agree to follow the study procedures
• Can Speak and read Arabic
• Can to access and use WhatsApp
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• People with T1DM or gestational diabetes
• People who have participated in any other clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The eligible participants will be randomly allocated to either intervention or control group. A simple randomisation with a 1:1 allocation ratio will be applied using computerised random number generator software (www.random.org). Each participant will be informed his/her randomisation allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM® SPSS® 24.0 will be used to analyse the data. Descriptive statistics will be used to summarise the socio-demographic and clinical data, including frequencies, percentages, means and standard deviations (SD). The generalised estimation equation (GEE) for repeated measurements will be used to examine the outcomes between groups. Adjusted analyses will be conducted for age group, gender, duration of illness and baseline outcome scores. The statistical significance will be the P value < 0.05. The intention to treat (ITT) analysis will includes every subject who is randomized to the study. The ITT ignores noncompliance, protocol deviations, withdrawal, and anything that happens after randomization. The missing outcome data for withdrawal elements will be imputed by last observation carried forward (LOCF) method, whereby the last measurement available for each participant before withdrawal is retained in analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
1/02/2023
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 23459 0
Saudi Arabia
State/province [1] 23459 0
Jazan Province

Funding & Sponsors
Funding source category [1] 307824 0
University
Name [1] 307824 0
the University of Newcastle
Country [1] 307824 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 308532 0
Other
Name [1] 308532 0
Saudi Arabian Cultural Mission (SACM)
Address [1] 308532 0
Gardens Flats, 16 Watson St, Turner ACT 2612
Country [1] 308532 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307829 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 307829 0
University Dr, Callaghan NSW 2308
Ethics committee country [1] 307829 0
Australia
Date submitted for ethics approval [1] 307829 0
26/02/2021
Approval date [1] 307829 0
19/10/2021
Ethics approval number [1] 307829 0
H-2021-025
Ethics committee name [2] 307841 0
Jazan Hospital Institutional Review Board
Ethics committee address [2] 307841 0
King Abdullaziz road, Alshawajrah, Jazan, Gizan region 82723
Ethics committee country [2] 307841 0
Saudi Arabia
Date submitted for ethics approval [2] 307841 0
07/07/2021
Approval date [2] 307841 0
Ethics approval number [2] 307841 0

Summary
Brief summary
Diabetic self-management education (DSME) is a program that conducted in health care facilities for people with type 2 diabetes (T2DM). However, not all patients are able to access DSME due to barriers such as clinic work overload for nurses and patients’ inability to attend due to work commitments. Social media is increasing being used to support patients with chronic health conditions. A randomised control feasibility trial (RCT) will be conducted in two diabetes centres in KSA, Jazan region. A DSME program will be conducted via WhatsApp to evaluate the effectiveness of this intervention on glycaemic control, diabetic knowledge, self-efficacy, anxiety, depression and HRQoL. blood test and all questionnaires to be completed at baseline - called the pre-test at time zero . Four questionnaires also need to be completed at 8th week – called a post–test at time one and again four questionnaires at 3 months after the baseline–called time two. a phone interview for evaluation of the intervention will also be conducted to explore participant’s perspective and acceptability of the content, identify strengths and weakness of the intervention, and seek recommendations for future improvement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108650 0
Dr Sharyn Hunter
Address 108650 0
University of Newcastle.University Drive, Callaghan NSW 2308 Australia
Country 108650 0
Australia
Phone 108650 0
+61 02 49215957
Fax 108650 0
Email 108650 0
[email protected]
Contact person for public queries
Name 108651 0
Mr Esmaeel Yaagoob
Address 108651 0
University of Newcastle.University Drive, Callaghan NSW 2308 Australia
Country 108651 0
Australia
Phone 108651 0
+61 0405131499
Fax 108651 0
Email 108651 0
[email protected]
Contact person for scientific queries
Name 108652 0
Mr Esmaeel
Address 108652 0
University of Newcastle.University Drive, Callaghan NSW 2308 Australia
Country 108652 0
Australia
Phone 108652 0
+61 0405131499
Fax 108652 0
Email 108652 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10574Study protocol  [email protected] Dr. Sharyn Hunter Project principal investigator... [More Details]
10575Ethical approval  [email protected] Dr. Sharyn Hunter Project supervisor



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.