Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05146466 |
| Other study ID # |
21125 |
| Secondary ID |
DIFA-2020-028 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2022 |
| Est. completion date |
November 22, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University College Cork |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Hypothesis: Is it feasible to conduct a definitive trial to test the effect of E-MATVR
compared to E-MATE on primary and secondary outcomes among Gaelic Athletic Association (GAA)
members (players and coaches)?
The overall aim of this study is to examine the feasibility of conducting a definitive trial
to test the effect of an educational intervention to Enhance Men's Awareness of Testicular
diseases using Virtual Reality (E-MATVR) among male GAA members.
The effect of E-MATVR will be compared to E-MATE (control) which involves using the same
information as E-MATVR delivered as plain text (e.g., PDF) with still images from E-MATVR.
Description:
1. Overall aim
To examine the feasibility of conducting a definitive trial to test the effect of
E-MATVR (intervention) compared to Electronic information only, E-MATE (control) on
testicular knowledge and testicular self-examination behaviours among male Gaelic
Athletic Association (GAA) members (i.e., players and coaches) over three months.
2. Design
According to Eldridge and colleagues, "feasibility study" is an umbrella term including
randomised/non-randomised pilot studies and/or other feasibility studies aimed to
determine whether a definitive trial can be done, should be done, and if so, how? To
answer these questions, we the investigators will conduct a feasibility study comprising
a feasibility trial, a study within a trial (SWAT), process evaluation and economic
evaluation. This registration only contains the detailed description of the protocol for
the feasibility trial.
A Study Within A Trial (SWAT) will be conducted prior to the feasibility trial to
determine which recruitment method (Twitter, Facebook or Quick Response [QR] code [via
distributed leaflet]) is more efficient and cost effective for recruiting men to this
feasibility study. A protocol for the SWAT is available in the SWAT Repository hosted at
Queen's University Belfast (insert once available).
A mixed- method process evaluation will be conducted to explore participants'
experiences of E-MATVR and E-MATE and potential sources of intervention failure. A
protocol for the process evaluation is available in HRB Open Research (insert once
available)
An economic evaluation will also be conducted to compare incremental costs and benefits
of E-MATVR with E-MATE. A cost-benefit analysis will be employed whereby the costs and
benefits will be measured in monetary terms. Data for the economic evaluation will be
collected within the outcomes measures for the feasibility trial at T1 (immediately
post-test) and T2 (three months follow up).
3. Objectives
1. Negotiate access with key stakeholders.
2. Identify unforeseen problems and safety issues.
3. Examine randomisation and blinding processes.
4. Provide estimates for sample size calculation for definitive trial.
4. Design
Randomised feasibility trial.
5. Participants
5.1 Inclusion criteria
1. Biological males
2. Members of the target GAA clubs since testicular injuries are common in field
sports like hurling.
3. Residing in Ireland.
4. Aged 18-50 years (age group at risk for testicular diseases).
5.2 Exclusion criteria
1. History of seizures.
2. History of motion sickness.
6. Setting
Data will be collected in up to 12 geographically dispersed GAA clubs, including
"Healthy Club" https://www.gaa.ie/my-gaa/community-and-health/healthy-club/).
7. Intervention
Intervention described below using the template for intervention description and
replication (TIDieR) checklist.
7.1 Brief name
E-MATVR.
7.2 Why?
Limitations from the investigators previous research were (i) the inclusion of men from
one university; (ii) short follow-up time; (iii) lack of randomisation/control group;
(iv) lack of an economic evaluation; and (v) lack of process evaluation. These will be
addressed in this project.
7.3 What?
E-MATVR is a computer software uploaded onto VR technology and delivered using a
headset, handheld controllers, and voiceover (all wireless). The voiceover script is
based on evidence from the investigators prior research and the Preconscious Awareness
to Action theoretical framework. The script's readability score (83.4 on the
Flesch-Kincaid test) indicates its suitability for sixth Graders.
E-MATVR comprises three gaming levels and takes approximately 10min to complete. The
user is required to complete one area to move to the next area. E-MATVR begins with a
popping series of words (like opening movie credits) as the voiceover reads them out.
These include light-hearted synonyms for the testes (e.g., balls, nuts, gonads). The
word "nuts" rather than "testes" is used to engage men with this intimate/sensitive
topic.
- Area 1 involves a 3D space with two walnuts. The user is asked by the voiceover to
move around the walnuts using the controllers, while providing facts about the
normal size and shape of the testes. Three changes (lump, swelling, and pain
[represented as flashing light]) then appear consecutively. These are accompanied
with a humorous emotional response from the voiceover. The user must find all three
changes to move to the next level.
- Area 2: A 3D model of a testis is used and the spermatic cord, epididymis, and
tumour are represented. The user is loaded into Level 2 on top of the testis.
During this level, the voiceover links symptoms experienced in Level 1 to
testicular structures. The spermatic cord lights up to indicate testicular torsion
and a purple lump appears, indicating a growth.
- Area 3: Key messages are reiterated by the voiceover using three icons: (i) a
snowflake to remind participants that their testes are unique and highlight the
importance of knowing what is normal for them; (ii) an infographic with the method
for testicular self-examination; and (iii) a red cross to prompt participants to
seek help for abnormalities and seek immediate attention for severe testicular
pain.
7.4 Who provided?
E-MATVR was developed by Mr Eoghan Cooke (Collaborator and Research Assistant) within an
MSc in Interactive Media supervised by Mr David Murphy (Co-Applicant). A Research
Assistant (Mr Billy O'Mahony) with interactive media expertise will test E-MATVR.
7.5 How?
E-MATVR is delivered using the latest VR technology (Oculus Quest 2
https://www.oculus.com/quest-2/) to give users a life-like experience, with imbedded
headphones and controllers that provide vibrational (haptic) feedback based on
participants' actions. The use of VR is explained, and participants are exposed to a
brief demonstration to practice the use of the technology. Participants are then exposed
to E-MATVR.
7.6 Where?
E-MATVR (wireless) will be tested in the target GAA clubs.
7.7 When?
Participants will complete E-MATVR once. E-MATVR takes approximately 10min to complete.
7.8 How much?
The number of VR users worldwide was 171 million in 2018, as compared to 200,000 in
2014. Worldwide spending on VR and augmented reality will grow between 2019-2023,
achieving a Compound Annual Growth Rate of 77% and delivering a 294 billion USD boost to
global Gross Domestic Product by supporting education and training. VR device ownership
and purchase intent are highest among men aged 18-39yrs. The surge in VR use led to
significant price drops. High-quality VR equipment is available for €138-€462
(https://www.oculus.com/compare/).
7.9 Tailoring/Modifications
Should a newer VR technology emerge, the E-MATVR software can be readily transferred in
full onto it.
7.10 How well?
User-friendliness, acceptability, and effectiveness (one-group pre-post pilot) of
E-MATVR were tested with 68 university students. Participants perceived E-MATVR as fun,
innovative, informative, memorable, and user-friendly. E-MATVR was successful in
increasing men's knowledge of testicular diseases, intentions to seek help for symptoms,
and testicular self-examination behaviours.
8. Control
E-MATE (E for Electronic information) will serve as the control arm. It involves using
the same information as E-MATVR delivered as plain text (e.g., PDF) with still images
from E-MATVR. Participants will be given 10min to read the text/look at images using an
iPad.
9. Outcomes
9.1 Primary outcomes
1. Testicular knowledge (Dichotomous)
2. Testicular self-examination behaviours (Dichotomous)
9.2 Secondary outcomes
1. Testicular awareness (Likert scale)
2. Help-seeking intentions (Likert scale)
3. Implementation intentions (Likert scale)
4. Perceived risk of testicular disorders (Likert scale)
Outcomes will be measured at baseline (T0), immediately post-test (T1), and three months
post-test (T2) using the Castor EDC software (https://www.castoredc.com/).
A Research Assistant and/or Research Support Officer will be present to ensure
participant safety. There is no in-person follow-up. Participants will be contacted
(phone call/text message/email) to ensure completion of outcome measurement at T2.
Non-respondents and those who withdraw will be considered lost to follow-up. Retention
is key to ensuring power and internal validity. This will be addressed in the SWAT
described below.
10. Sample size
Given that the goal of a feasibility trial is to identify problems that would impede the
conduct of a larger, definitive efficacy trial, the investigators set the sample size at
59 based on advice from Viechtbauer et al. (2015) which is aimed at being able to detect
failures in study processes that would occur just 5% of the time (with 95% confidence).
Bearing in mind a potential attrition rate of 25%, 74 participants will be recruited.
11. Randomisation and allocation concealment
For each of the participating GAA clubs, individual participants will be randomised with
the same probability to one of the two arms (E-MATVR/E-MATE). Allocation concealment
will be maintained using a computerised system. Once participants have consented and
their baseline assessment has been entered into the computer database, their allocation
will be given by automated email. Randomisation and allocation concealment will be
conducted according to the standard operating procedures (SOPs) of the Statistics and
Data Analysis Unit of the HRB Clinical Research Facility-Cork (HRB CRF-C).
12. Blinding
Given the differences between the two arms, participants will be aware of the arm they
have been randomised into. Outcome assessments will be self-reported and returned to
research staff with no information on allocation. Blinding will be maintained throughout
data analysis. Unblinding will be facilitated by the independent statistician following
completion of the protocol-specified data analysis.
13. Data analysis
Analyses will be conducted by the lead statistician, under the SOPs of the Statistics
and Data Analysis Unit of the HRB CRF-C. Before recruitment, a detailed Statistical
Analysis Plan will be uploaded alongside the study protocol to the relevant registries.
Data will undergo extensive quality checking and potential errors will be verified from
source data a priori.
Analyses of outcomes will be conducted on an intention-to-treat basis. Differences in
outcomes by study arm, over time, will be estimated using generalised linear mixed
effects models with the appropriate link function (based on the distribution of the
outcome or expected error distribution). The investigators will report minimally
adjusted models, which will include effects of intervention arm and time. The
investigators will report a fully adjusted model that includes the key predictor
variables collected at baseline. Missing data will be evaluated and addressed using
appropriate methods (e.g., multiple imputation or inverse-probability weighting). Effect
estimates for all pre-specified primary and secondary endpoints, will be publicly
reported with 95%CI and exact p-values, in accordance with recent guidance from the
American Statistical Association.
Analyses will be conducted using transparent, open-science tools. All analysis steps,
including cleaning or modifications to study database, will be fully scripted and
replicable. Scripts for the key analyses will undergo testing prior to data analysis.
Upon completion, the study database will be prepared according to FAIR data principles
and be made available along-side the analysis scripts.
14. Ethical considerations
This study will be conducted in line with ethical principles depicted in the Declaration of
Helsinki. Ethical approval will be sought from the Clinical Research Ethics Committee at UCC.
Participants will be provided with an information leaflet and will sign informed consent.
Participants will be asked to check with their General Practitioner for abnormalities (e.g.,
lump) identified during testicular self-examination. Participants will also be asked to visit
the emergency department for sudden and severe testicular pain which is often associated with
emergencies such as testicular torsion.
