This study's general objective is to develop GRVOTS mobile apps and assess its impact on TB treatment adherence among working-age populations.
Design
Single Arm Intervention Study
Settings and conduct
Health care facilities (Clinics and Hospital)
Participants/Inclusion and exclusion criteria
Inclusion
1-Ability to speak and read English or BM
2-Working-aged TB patients (18-64 years old)
3-Newly diagnosed with PTB (first-line treatment)
4-Has completed the in-person DOT at least two weeks (ensuring medications tolerance) (Garfein et.al., 2015)
5-Willing and able to provide informed consent
6-Knowledge in smartphone and apps usage
Exclusion
1-Patients with drug-resistant TB
2-Patients with health conditions that disallow them to use smartphone (severe arthritis, vision impairment)3-Patients with no knowledge of smartphone usage
Intervention groups
Patient will be given GRVOTS mobile apps that enable them to virtually record their medication intake via Video Direct Observed Therapy (VDOTS) as a method to monitor their medication adherence daily instead of coming to the healthcare facilities to enable their drug intake being observed physically . Supervisor or the healthcare staff will received the VDOTS daily via the GRVOTS mobile apps and approved them. After 2 months of usage, we calculate the numbers of video sent and ask them to fill up the questionnaire to see their level of motivation and medication adherence
Main outcome variables
Numbers of video (VDOTS ) received
General information
Reason for update
Acronym
GRVOTS
IRCT registration information
IRCT registration number:IRCT20230308057657N1
Registration date:2023-03-15, 1401/12/24
Registration timing:retrospective
Last update:2023-03-15, 1401/12/24
Update count:0
Registration date
2023-03-15, 1401/12/24
Registrant information
Name
Siti Aishah Abas
Name of organization / entity
Universiti Teknologi MARA
Country
Malaysia
Phone
+60 11-1931 4599
Email address
aishah.abas@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-31, 1401/11/11
Expected recruitment end date
2023-03-28, 1402/01/08
Actual recruitment start date
2023-01-31, 1401/11/11
Actual recruitment end date
2023-02-10, 1401/11/21
Trial completion date
2023-04-10, 1402/01/21
Scientific title
Gamified-Reality-Video-Observed-Therapy (GRVOTS) Mobile Apps Impact On Tuberculosis Treatment Adherence Among Working Age Population
Public title
GRVOTS for Tuberculosis patient
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to speak and read English or BM
Working-aged TB patients (19-64 years old)
Newly diagnosed with PTB (first-line treatment)
Has completed the in-person DOT at least two weeks (ensuring medications tolerance)
Willing and able to provide informed consent
Knowledge in smartphone and apps usage
Exclusion criteria:
Patients with drug-resistant TB
Patients with health conditions that disallow them to use a smartphone (severe arthritis, vision impairment)
Patients with no knowledge of smartphone usage
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Actual sample size reached:
71
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee Universiti Teknologi Mara
Street address
47000 Sungai Buloh, Selangor, Malaysia
City
Sungai Buloh
Postal code
47000
Approval date
2021-07-23, 1400/05/01
Ethics committee reference number
REC/07/2021(MR/595)
Health conditions studied
1
Description of health condition studied
Tuberculosis patient treatment adherence
ICD-10 code
A16.0
ICD-10 code description
Tuberculosis of lung, bacteriologically and histologically negativeTuberculous: bronchiectasis, fibrosis of lung, pneumonia, pneumothorax, bacteriologically and histologically negative
Primary outcomes
1
Description
Number of video received via the mobile apps (VDOTS)
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
Number of video (VDOTS) received
2
Description
Medication Adherence Score
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
My MAAT (Malaysian Medication Adherence Assessment Tools)
3
Description
Motivation Score
Timepoint
Baseline (before intervention) and 4 and 8 weeks after intervention
Method of measurement
Intrinsic Motivation Inventory (IMI Tools)
Secondary outcomes
empty
Intervention groups
1
Description
Patient will be given GRVOTS mobile apps that enable them to virtually record their medication intake via Video Direct Observed Therapy (VDOTS) as a method to monitor their medication adherence daily instead of coming to the healthcare facilities to enable their drug intake being observed physically . Supervisor or the healthcare staff will received the VDOTS daily via the GRVOTS mobile apps and approved them. After 2 months of usage, we calculate the numbers of video sent and ask them to fill up the questionnaire to see their level of motivation and medication adherence
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Malaysia Ministry of Health heath facilities
Full name of responsible person
Siti Aishah Binti Abas
Street address
Jalan Nusari 4/4
City
Seremban
Postal code
70300
Phone
+60 11-1931 4599
Email
aishah.abas@gmail.com
Web page address
https://www.uitm.edu.my/index.php/en/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
World Health Organization
Full name of responsible person
Nurhuda Ismail
Street address
47000 Sungai Buloh, Selangor, Malaysia
City
Sungai Buloh
Postal code
47000
Phone
+60 3-6126 7174
Fax
+60 3-6126 7234
Email
yuda@uitm.edu.my
Web page address
https://www.uitm.edu.my/index.php/en/
Grant name
Joint TDR/World Health Organization Western Pacific Region Small Grant Scheme for Implementation Research.
Grant code / Reference number
TR590324
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
World Health Organization
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Nurhuda Ismail
Position
Dr
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
47000 Sungai Buloh, Selangor, Malaysia
City
Sungai Buloh
Province
Selangor
Postal code
47000
Phone
36126500
Fax
+60 3-6126 7234
Email
yuda@uitm.edu.my
Web page address
https://www.uitm.edu.my/index.php/en/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Siti Aishah Abas
Position
Dr
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
Jalan Nusari 4/4, Nusari Aman2, Bdr Sri Sendayan
City
Seremban
Province
Negeri Sembilan
Postal code
70300
Phone
+60 11-1931 4599
Fax
Email
aishah.abas@gmail.com
Web page address
https://www.uitm.edu.my/index.php/en/
Person responsible for updating data
Contact
Name of organization / entity
Universiti Teknologi MARA
Full name of responsible person
Siti Aishah Abas
Position
Dr
Latest degree
Master
Other areas of specialty/work
Public Health/Community Medicine
Street address
Jalan Nusari 4/4, Nusari Aman2, Bdr Sri Sendayan
City
Seremban
Province
Negeri Sembilan
Postal code
70300
Phone
+60 11-1931 4599
Email
aishah.abas@gmail.com
Web page address
https://www.uitm.edu.my/index.php/en/
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
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
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
Title and more details about the data/document
Published research report that contains all the findings of the study.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in the academic area
Under which criteria data/document could be used
for scientific use
From where data/document is obtainable
scientific journal
What processes are involved for a request to access data/document