Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000604101
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
18/04/2019
Date last updated
20/03/2020
Date data sharing statement initially provided
18/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Makeway Lab, a mobile makerspace for hospitals making a change for hemodialysis patients
Scientific title
Makeway Lab, effect of a mobile makerspace on the hospital experience and psychological wellbeing of hemodialysis patients.
Secondary ID [1] 297872 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
MWL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodialysis 312244 0
Mental Health 312245 0
Condition category
Condition code
Renal and Urogenital 310791 310791 0 0
Kidney disease
Mental Health 310792 310792 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Makeway Lab, a mobile makerspace for hospital
The hospital inquiry will involve a series of recruitment, administration, maker workshops, and data collection procedures.
The Makeway Lab is a mobile makerspace designed for use by patients in hospitals. It carries digital design and fabrication technology such as 3D printer, scanners, cutters, for the purpose of building creative or functional objects.
Inquiry Procedure
With ethics approval and final arrangements with the Sunshine Cost University Hospital (SCUH) and Nambour General Hospital (NGH) the recruitment process will commence. The research will involve a group of 10-15 adult (aged 18 years and older) Sunshine Coast residents who are receiving dialysis treatment.
To recruit participants a flyer will be distributed to patients across the renal dialysis units SCUH and NGH.
The flyer will be posted on the wall in the Renal Ward and other (physical and online locations) recommended by Queensland Health (QH) employees.
The flyer will be distributed by the Renal Team members or other associated QH employees.
To assist the recruitment process QH employees may introduce the PI to the potential participant to address any questions.
If there are more than 15 people expressed interest, those who are not selected will be offered a Makeway Lab demonstration/workshop opportunity.. This material includes the, recruitment flyer, project information, Participant Information. Participant recruitment will be managed in consultation with the Renal Teams.
Participant Information Session - The researcher will provide two demonstrations of the Makeway Lab and introduce the research to potential participants and rental staff. The session will provide detail the maker activities and things that can be made; detail the information to be collected and how the information will be used; and discuss the recruitment and consent process. This session will be located at the hospitals where the participants are being treated. This session will take 30 minutes to 1 hour.
Consent Process - Each participant will complete the consent form.
WHO-5 Questionnaire 1 - Each participant will complete the WHO-5 questionnaire. This can be completed at the participant’s hospital or home. The questionnaire will take 5 to 10 minutes
Semi-Structured Interview 1 - An audio recorded interview will be undertaken at the participant’s hospital (or other agreed location). The interviews will each take 30 minutes to 1 hour.
Maker Workshops - will be delivered at the participant’s hospital to coincide with their scheduled visits. It is anticipated that each participant will undertake at least 6 and up to 8 maker workshops. The duration of each workshop session is 2 - 3hrs dependent on the energy of the participant/s. The researcher will instruct and guide each participant through a series of activities, including:
an introductory session with the iPad/Apple Pen/Apps;
a play/practice session with the tools and equipment;
design and fabricate sessions to create small to more complex objects using the 3D Printer;
The researcher will document/photograph the results of the activities.
Group connection - direct and online connection with the other participants will be encouraged. A closed FaceBook group will be created for the participants to share and discuss the maker activities and experiences. The closed Facebook group will not be moderated, it is used for the online communication and connection of the participants; facilitator/ researcher (principal investigator).
WHO-5 Questionnaire 2 - Each participant will complete the WHO-5 questionnaire.
Semi-Structured Interview 2 - An audio recorded interview
Display - Potentially a display of participant’s projects will be installed at the end of the inquiry. The display will be located at the hospital and / or at an agreed location.
Group Evaluation Session - Discuss the outcomes, the successes and problems; Where to next with the activity for the individual participant and group. This session will take 30 minutes to 1 hour.
Closing / Celebration Event - Potentially, a display of participant’s projects will be installed and presented to the hospital community and participant’s family and friends. The display will be located at the hospital and / or at an agreed location.
Intervention code [1] 314105 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319637 0
A % with an emotional well-being score >13. According the the World Health Organisation (WHO) - 5 scale. WHO-5 is a 5 item questionnaire self-administered before and after the intervention.
Timepoint [1] 319637 0
At the end of the 6 - 8 week intervention
Secondary outcome [1] 368977 0
A change in motivation assessed through data gathered from participant observations (e.g. noted by researchers during maker sessions and the closed FaceBook group), the WHO-5 questionnaire and 2 face-to-face interviews. The semi-structured interviews will take 30-45minutes and will include an audio recording.
Timepoint [1] 368977 0
Face-to-face interviews 1 will take place prior to the start of the Maker workshop sessions.
Face-to-face interviews 2 will take place at the end Maker workshop sessions.
Secondary outcome [2] 368979 0
A change in hospital experience assessed through data gathered from participant observations (e.g. noted by researchers during maker sessions and the closed FaceBook group), the WHO-5 questionnaire and 2 face-to-face interviews. The semi-structured interviews will take 30-45minutes and will include an audio recording.
Timepoint [2] 368979 0
Face-to-face interviews 1 will take place prior to the start of the Maker workshop sessions.
Face-to-face interviews 2 will take place at the end Maker workshop sessions.
Secondary outcome [3] 369387 0
A change in self-efficacy assessed through data gathered from participant observations (e.g. noted by researchers during maker sessions and the closed FaceBook group), the WHO-5 questionnaire and 2 face-to-face interviews. The semi-structured interviews will take 30-45minutes and will include an audio recording.
Timepoint [3] 369387 0
Face-to-face interviews 1 will take place prior to the start of the Maker workshop sessions.
Face-to-face interviews 2 will take place at the end Maker workshop sessions.

Eligibility
Key inclusion criteria
The participants must:
- be aged 18 years or older.
- be a renal dialysis patients.
- have a good understanding of computer technology.
- be willing to participate in the activity for a 6-8 week period.
- be prepared to connect with other participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants would not be selected if they were not available for the full period; or who have little experience with computer technology.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
It was decided that 15 participants would be the maximum number for the inquiry because of: the intensive face-to-face workshop facilitation; the accommodate participant's dialysis schedule across two sites. It is expected that the workshops will involve 2-3 participants at each session and that each participant will experience at least 6 sessions over a period of 6-8 weeks.
Analysis
Applying Self-Efficacy Theory
In his seminal work Self-efficacy: Towards a Unifying Theory (1977) Bandura explains that efficacy expectations are learned from four major sources: (1) performance accomplishment, (2) vicarious experience, (3) verbal persuasion, and (4) physiological state.
The theory, with a focus on the four sources of self-efficacy, will be used as a framework to analyse the data. The following provides an explanation of the application of the sources.
1. Performance accomplishments refers to learning through personal experience where a person accomplishes a new or difficult task and as a result enjoys an increase in self-efficacy. 'Performance accomplishments attained through personal experience are the most potent source of efficacy expectation' (Riekert, Ockene, & Pbert, 2013, p. 5). The opportunities and motivation to learn and experience new things are greatly diminished when undergoing HD. It is understood that a changing sense of agency is experienced by those living with kidney disease ((AIHW), 2016; Randolph, 2002). Given this, investigation and research such as this, to understand these changes and determine the value of interventions such as the Makeway Lab to improve wellbeing of HD patients is warranted.
Performance accomplishment will be evident through the participants’ mastery of the use and understanding of the new technology. Dellot (2015) explains that 'the act of making is one means of regaining mastery over technology – not just because it enables us to be more self-reliant but also because it can boost our sense of agency’ (p. 5). As Pajares (1996) explains, 'guided mastery is a powerful vehicle for instilling a robust sense of coping efficacy in people whose functioning is seriously impaired by intense apprehension’ (p. 5). Through a scaffold learning process over a period of 6 - 8 weeks the research participants will learn (to an introductory level) design and fabrication software and equipment such as 3D printers to realise a series of maker projects. It is expected that the participants’ mastery over the technology will serve to elevate their self-efficacy and build a stronger sense of agency.
2. Bandura (1977) explains that vicarious experience includes learning that occurs through observation of events and / or other people. These events and people are referred to as ‘models’ when they display a set of behaviours or stimulus array that illustrates a certain principle, rule or response. For example, for this research it is believed that the experience of being in an environment among dialysis patients with low self-efficacy would have a negative affect on the patient group. If however they were part of a group of patients who are accomplishing new and interesting tasks than this could serve to enhance and enthuse their efficacy expectations.
Vicarious experience is of particular interest which I plan to explore it not only as a person-to-person influence but also the positive and negative experience brought by the setting or environment. This inquiry will be held two hospitals on the Sunshine Coast. One a newly opened facility and the other a long established regional hospital. These two have different dialysis ward layouts The newer has a series of spacious bays with two chairs and the older a crowded single room with six chairs. Potentially, I believe that new hospital layouts will add to the patient’s sense of social insolation and that the older is more conducive to building a supporting community. In order to build the vicarious experience for the participants located in the new hospital, the online community (closed FaceBook group of participants) will be important communication platform.
3. Verbal persuasion constitutes the third source of efficacy expectations. As Bandura (1977) explains this method is quite familiar to all health educators who have exhorted patients to persevere in their efforts to change behaviour. In this case the research community including, the participant collective, the facilitator, and healthcare workers will be the source for providing encouraging and supporting messages. This community approach is aligned with the makerspace ethos. Ideally two or more participants will be working alongside each other at any one time, to provide the vicarious experience and verbal persuasion needed. Also, ideally the group will, during the course of the program connect (face-to-face or online) to discuss and celebrate their achievements. In addition to acting as a researcher facilitator I have a responsibility as a 'self-efficacy builder' (McKim & Velez, 2016, p. 74) to both conveying positive appraisals and structure scaffold learning in ways that bring success and avoid placing the participants in situations where they are likely to fail.
4. Physiological state provides information that can influence efficacy expectations. Bandura (1997) noted that because high physiological arousal usually impairs performance, people are more likely to expect failure when they are very tense and viscerally agitated (p. 106). Cioffi (1991) adds that efficacy beliefs can be improved by enhancing the physical status of the person by reducing their stress levels and negative tendencies.
From the data it will be important to determine if the participant’s physiological state is benefited by the presence of the Makeway Lab. These maker activities could happen through the use of remote bureaus, to print and fabricate the participant’s designs however I believed having the Makeway Lab located near the participant, will encourage (and even inspire) their creativity and help improve their motivation and sense of self and by doing so reduce the stress levels and provide them positive opportunities.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
18/09/2020
Actual
Date of last data collection
Anticipated
27/11/2020
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13538 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 13539 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 26161 0
4575 - Birtinya
Recruitment postcode(s) [2] 26162 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 302395 0
University
Name [1] 302395 0
Queensland University of Technology
Country [1] 302395 0
Australia
Primary sponsor type
Individual
Name
John Waldron
Address
Blue Sky View
4 Glenhaven Court, Palmview Qld 4553
Country
Australia
Secondary sponsor category [1] 302286 0
Hospital
Name [1] 302286 0
Sunshine Coast University Hospital
Address [1] 302286 0
6 Doherty St, Birtinya QLD 4575
Country [1] 302286 0
Australia
Secondary sponsor category [2] 302355 0
Hospital
Name [2] 302355 0
Nambour General Hospital
Address [2] 302355 0
Hospital Road, Nambour QLD 4560
Country [2] 302355 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303067 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 303067 0
Ethics committee country [1] 303067 0
Australia
Date submitted for ethics approval [1] 303067 0
14/01/2019
Approval date [1] 303067 0
20/03/2019
Ethics approval number [1] 303067 0
Project ID 43400: Makeway Lab

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

Contacts
Principal investigator
Name 92350 0
Mr John Waldron
Address 92350 0
Creative Industries
Queensland University of Technology
2 George Street
Brisbane Qld 4000
Country 92350 0
Australia
Phone 92350 0
+61 468453362
Fax 92350 0
Email 92350 0
[email protected]
Contact person for public queries
Name 92351 0
John Waldron
Address 92351 0
Creative Industries
Queensland University of Technology
2 George Street
Brisbane Qld 4000
Country 92351 0
Australia
Phone 92351 0
+61 468453362
Fax 92351 0
Email 92351 0
[email protected]
Contact person for scientific queries
Name 92352 0
John Waldron
Address 92352 0
Creative Industries
Queensland University of Technology
2 George Street
Brisbane Qld 4000
Country 92352 0
Australia
Phone 92352 0
+61 468453362
Fax 92352 0
Email 92352 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 collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator via email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1835Ethical approval    377323-(Uploaded-12-04-2019-11-16-55)-Study-related document.pdf
1836Study protocol    377323-(Uploaded-12-04-2019-11-18-49)-Study-related document.pdf
1837Informed consent form    377323-(Uploaded-10-04-2019-11-20-47)-Study-related document.pdf



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.