Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000085976p
Ethics application status
Submitted, not yet approved
Date submitted
6/12/2019
Date registered
3/02/2020
Date last updated
27/05/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Facebook Intervention to Improve Glycemic Control of Type 2 Diabetes Patients of Bangladesh
Scientific title
Social Media (Facebook) Based Educational Intervention to Improve Glycemic Control of Type 2 Diabetes Patients of Urban Area of Bangladesh: Protocol for a Randomized Controlled Trial
Secondary ID [1] 300031 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 315534 0
Condition category
Condition code
Public Health 313818 313818 0 0
Health promotion/education
Metabolic and Endocrine 313898 313898 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present study will be a randomized controlled trial, comparing (1) standard care (n = 60) with (2) standard care plus a Facebook based educational intervention (n = 60) for 6 months among patients with type 2 diabetes residing in Dhaka city.
All the intervention will be provided through a closed and hidden Facebook group moderated by a facilitator who is a qualified physician with 18 years of experience in diabetes management. Participants can join a hidden group by invitation only and the group and contents are not visible to anyone on Facebook except participants. No one searching on Facebook will find the group or be able to request to join as well as group membership or contents will not be visible on the participants’ personal Facebook timelines. This will minimize potential concerns about internet privacy and group policy/guideline will emphasize confidentiality of all content. Further it will hide the intervention materials from control groups and other Facebook users to robust the study design.
Intervention tools will be consisted of educational video and blog post developed based on the principles of behavioral learning theory and transtheoretical model of behavioral change using different national and international guidelines for diabetes. Total eight 15-minute narrative educational videos and two patient interview videos will be developed by a culturally sensitive approach to the context with regard to the character, language and cultural practices. Educational videos will be narrated by an expert diabetologist and cover a range of diabetic education including (1) general perspectives and pathophysiology of diabetes, (2) diagnostic procedures and their interpretations, (3) guideline for diet, (4) guideline of exercise, (5) guidelines for diabetes self-care techniques like blood glucose self-monitoring, foot care, regular follow up visits etc., (6) importance of adherence to drugs, (7) knowledge and self-efficacy of insulin use and (8) complications of diabetes and their preventions. Two patient interview videos conducted by expert diabetologist will demonstrate their life experience with diabetes and measures they followed to achieve good glycemic control. Videos will be uploaded in the Facebook group once weekly. Along with educational videos ten jargon free culturally sensitive blog posts, written and evaluated by expert diabetologists each containing around 500 to 1000 words covering diabetic self-care, diet, exercise, and medication guidelines will be posted weekly with each video. Educational videos and blog posts will be followed by an interactive session with diabetologist in comment section where questions raised by the participants will be answered accordingly. Participation is not mandetory rather participation is entirely discretionary.

Participants will be tagged by name in the video and posts so that it reaches in their timeline and notification bar. Adherence to the intervention will be monitored by Facebook analytics and if the adherence is not satisfactory, participant miss a video or blog within 48 hours of publication, he/she will be notified by Facebook messenger.
Intervention code [1] 316305 0
Behaviour
Intervention code [2] 316357 0
Treatment: Other
Comparator / control treatment
Standard diabetic care defined as local guideline (National Guidelines for Diabetes in Bangladesh 2013, ISBN: 948-984-33-6854-6 (NLM)).
Control group
Active

Outcomes
Primary outcome [1] 322215 0
Change in HbA1c level, measured by serum assay (Ion Exchange Chromatography method)
Timepoint [1] 322215 0
6 months, post-baseline
Secondary outcome [1] 377759 0
knowledge about diabetes (measured by mean change in score of Diabetes Knowledge Test)
Timepoint [1] 377759 0
6 months, post-baseline
Secondary outcome [2] 377760 0
attitude towards diabetes (measured by mean change in score of Diabetes attitude scale)
Timepoint [2] 377760 0
6 months, post-baseline

Eligibility
Key inclusion criteria
• Diagnosed as type 2 diabetic patient according to WHO criteria
• Currently on oral hypoglycemic therapy or insulin or both and able to afford cost for 6 months treatment
• Patients with a personal mobile phone and a Facebook account and use it regularly
• Willingness to follow intervening Facebook page and join the Facebook group for 6 months
• Agree for a follow up visit after 6 months (reminders will be sent for the follow up visit)
• Provide written informed consent
• Residing in Dhaka city
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with other types of diabetes, such as diagnosed as type 1 diabetes, gestational diabetes
• Patients whose clinical condition might have interfered with the study such as mental illness, other serious illness or co-morbidities requiring hospitalization.
• Patients unable to give their informed consent or agree for follow up visit.
• Patients who do not own a mobile phone and/or regularly using Facebook account
• Residing outside Dhaka city

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
All statistical analyses will be done using SPSS version 24.0 (IBM Corporation, USA). Data coding, quality control and data entry will be done using precoded questionnaire to minimize coding errors. All data forms and questionnaires will be checked for errors and necessary corrections will be made before entry of data. Frequency distributions will be used to identify outliers. In all analyses, potential confounding variables and effect modifiers will be considered. chi square test will be used to detect heterogenecity of the characteristics between intervention and control groups.
Effect of Facebook based educational intervention will be evaluated by comparing the longitudinal change in serum HbA1c level changes between intervention and control groups. The change in HbA1C will be defined as the difference between mean HbA1c at the baseline survey and minus that at the second survey and standardized for the time between surveys. Secondary outcome will be measured in the same way as comparing the change of mean score of DKT and Diabetes attitude scale between two groups between baseline survey and secondary survey. ‘t-test’ will be used to compare two means between intervention and control groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
30/07/2020
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 22171 0
Bangladesh
State/province [1] 22171 0
Dhaka

Funding & Sponsors
Funding source category [1] 304486 0
Charities/Societies/Foundations
Name [1] 304486 0
Dhaka Cast
Country [1] 304486 0
Bangladesh
Primary sponsor type
Charities/Societies/Foundations
Name
Dhaka Cast
Address
organisation: Dhaka Cast
street number/name: House 19,road 5, ,sector 11
town/city: Uttara Dhaka, postcode: 1205 and state/province: Dhaka
Country
Bangladesh
Secondary sponsor category [1] 304755 0
University
Name [1] 304755 0
University of Rajshahi
Address [1] 304755 0
Department of Statistics, University of Rajshahi, Rajshahi-6205, Bangladesh
Country [1] 304755 0
Bangladesh
Other collaborator category [1] 281090 0
University
Name [1] 281090 0
Rajshahi Medical College
Address [1] 281090 0
Medical College Road, Sipaipara, Rajpara, Rajshahi-6000, Bangladesh
Country [1] 281090 0
Bangladesh

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304918 0
Ethical Review committee, Rajshahi Medical College
Ethics committee address [1] 304918 0
Ethics committee country [1] 304918 0
Bangladesh
Date submitted for ethics approval [1] 304918 0
02/12/2019
Approval date [1] 304918 0
Ethics approval number [1] 304918 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98638 0
Mr Md. Abdur Rafi
Address 98638 0
Rajshahi Medical College, Rajshahi-6000, Bangladesh
&
Co-founder and chief research officer
organisation: Dhaka Cast
street number/name: House 19,road 5, ,sector 11
town/city: Uttara Dhaka, postcode: 1205 and state/province: Dhaka
Country 98638 0
Bangladesh
Phone 98638 0
+8801768798318
Fax 98638 0
Email 98638 0
[email protected]
Contact person for public queries
Name 98639 0
Md. Abdur Rafi
Address 98639 0
Rajshahi Medical College, Rajshahi-6000, Bangladesh
&
Co-founder and chief research officer
organisation: Dhaka Cast
street number/name: House 19,road 5, ,sector 11
town/city: Uttara Dhaka, postcode: 1205 and state/province: Dhaka
Country 98639 0
Bangladesh
Phone 98639 0
+8801768798318
Fax 98639 0
Email 98639 0
[email protected]
Contact person for scientific queries
Name 98640 0
Md. Abdur Rafi
Address 98640 0
Rajshahi Medical College, Rajshahi-6000, Bangladesh
&
Co-founder and chief research officer
organisation: Dhaka Cast
street number/name: House 19,road 5, ,sector 11
town/city: Uttara Dhaka, postcode: 1205 and state/province: Dhaka
Country 98640 0
Bangladesh
Phone 98640 0
+8801768798318
Fax 98640 0
Email 98640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
MD. ABDUR RAFI
Rajshahi Medical College
email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.