Home » Trials » SLCTR/2020/010


Effectiveness of a social media-based intervention in Sinhala medium to improve health literacy among adult social media users in Kalutara District

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SLCTR Registration Number

SLCTR/2020/010


Date of Registration

30 Mar 2020

The date of last modification

Apr 22, 2020



Application Summary


Scientific Title of Trial

Effectiveness of a social media-based intervention in Sinhala medium to improve health literacy among adult social media users in Kalutara District


Public Title of Trial

Effectiveness of a Facebook based intervention in Sinhala medium to improve health literacy among adult social media users in Kalutara district


Disease or Health Condition(s) Studied

Health literacy


Scientific Acronym

None


Public Acronym

HLS


Brief title

Social media for Heath literacy


Universal Trial Number

U1111-1245-7931


Any other number(s) assigned to the trial and issuing authority

EC-19-123


Trial Details


What is the research question being addressed?

Can Facebook based social media improve health literacy among adult social media users in Kalutara District?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Prevention


Study Phase

Not Applicable


Intervention(s) planned

1.Study setting: Four selected Divisional Secretariat (DS) areas in Kalutara district. Thirty-eight Grama Niladari (GN) divisions will be selected from the selected DS areas, according to Probability Proportionate to Size (PPS). One cluster will be selected from each GN division. 2.Method of Randomization: Randomization of cluster will be done after the pre-intervention assessment. 3.Intervention: • The intervention will be completely based on Facebook. • Two “closed/secret” Facebook groups will be created for intervention & control arms. • Only the intervention group will receive the Facebook posts. • The implementation will be done under the direct supervision of PI and he will hold the sole administrative authority of the intervention. As this is an interactive intervention the participants also can share their comments. Any content shared to this group will appear only after the approval of the Administrator ( PI) • Minimum of 2 and maximum of 5 new predesigned posts will shared daily for six months. But there will be more interactive posts/comments based on the engagement of the participants. • An independent monitoring committee will be appointed to monitor the trial.


Inclusion criteria

Adult ‘active Facebook users’ aged 25 - 60 years who are permanent residents in selected DS divisions.

In this study ‘active Facebook user’ will be defined as a person who login at least once a week to the Facebook account which has been registered under his or her name through a computer or a mobile devise.


Exclusion criteria

  1. Individuals with psychological or cognitive impairment.
  2. People who are not able to read or converse in Sinhala.
  3. Participants in first component of MD study(Cross sectional study)


Primary outcome(s)

1.

Difference of Health literacy index (mean difference) in the intervention and the control group Health Literacy Survey – Europe – Questionnaire 47 (HLS-EU-Q47) which is locally adapted and validated will be used to assess health literacy.

[

Prior to the intervention and 6 months after the commencement of the intervention. (Pre and post assessments will be done through a paper-based interviewer administered questionnaire after a face to face interview)

]
2.

Proportion of adults with limited health literacy in the intervention and the control group (Defined as a HLS-EU-Q47 score equal or below 33 )

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Prior to the intervention and 6 months after the commencement of the intervention

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Secondary outcome(s)

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Proportion of adults who participated for selected health screening programmes. Eg: Well woman clinic, healthy life style clinic

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Prior to the intervention and 6 months after the commencement of the intervention

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Proportions of individuals who consume adequate level of fruits and vegetables and salt according to the STEPS survey

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Prior to the intervention and 6 months after the commencement of the intervention

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Proportions of individuals who have adequate level of exercise according to the STEPS survey

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Prior to the intervention and 6 months after the commencement of the intervention

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Proportion of adults who consume tobacco

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Prior to the intervention and 6 months after the commencement of the intervention

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Proportion of adults who consume excessive amount of alcohol

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Prior to the intervention and 6 months after the commencement of the intervention

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Proportion of adults with self-reported unmet need for health care

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Prior to the intervention and 6 months after the commencement of the intervention

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Target number/sample size

570 adults ( 15 adults in on each cluster and 19 clusters in each arm.)


Countries of recruitment

Sri Lanka


Anticipated start date

2020-04-05


Anticipated end date

2020-09-15


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Ministry of Health


Regulatory approvals

Ministry of Health



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-12-19


Approval number

EC-19-123


Details of Ethics Review Committee

Name: Ethics Review Committee, Colombo
Institutional Address:Faculty of Medicine, University of Medicine, 271, Kynsey Road, Colombo 08
Telephone:0112695300 ext 240
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

W.M.S.Weerakoon
Registrar in Community Medicine
National Cancer Control Programme, 555/5 , Public Health Complex, Elvitigala Mavatha, Colombo 05.
0112368627
0773472718
0112368627
wms.weerakoon@gamail.com
http://www.nccp.health.gov.lk

Contact Person for Public Queries

Dr Sudath Samaraweera
Chief epidemiologist
Epidemiology Unit 231. De Saram Pl, Colombo 01 Sri Lanka
0112 695 112
0777903407

sudath.samara@gmail.com


Primary study sponsor/organization

Ministry of Health
-
385, Rev. Baddegama Wimalawansa Thero Mawatha. Colombo 10.
01126699192
0112693866
postmaster@health.gov.lk
www.health.gov.lk

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data which is used to generate results will be shared immediately following publication after de-identification (text, tables, figures and appendices). Study protocol, statistical analysis plan and analytic code will be available. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims in an approved proposal. Proposals should be directed to wms.weerakoon@gmail.com. To gain access, data requestors will need to sign a data access agreement.


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results