Swansea Bay University Health Board
Swansea, SA6 6NL, United Kingdom
NCT Number: NCT04836624
Assistive technology is an important tool in helping people maintain independence, allowing them to actively participate in education, work, and society. If maximised to its full potential there would be significant health and wellbeing benefits for individuals, reduced reliance on formal health and social care services and reduced healthcare costs. However, current equipment is often unsuitable in meeting an individual's needs. Previous review work by the research team highlighted issues with the design, function, and service provision of assistive technology as barriers to its use. Two specific barriers, a lack of equipment customisation and a lack of end-user involvement in the provision process, are the focus of this work.
This research aims to assess a new method that provides personalised assistive technology to individuals. The method will actively engage participants to input into the design of their own assistive device(s) to help them overcome their challenges of daily living. This method will help enable the device to be customized to their needs, a process known as co-design. Participants will be recruited from Swansea Bay University Health Board with a range of long-term physical health conditions whose current needs are unable to be met by current standard and off-the-shelf assistive technology solutions. Participants must be aged 18+ and currently living within the community.
Participants will be involved in up to 6 interactive sessions spread over 3 months with the researcher. In the initial session the researcher will work with the participants to identify challenges in daily living for the device to overcome. In subsequent sessions, the researcher will design different solutions for the participant to try and feedback on, enabling the design to be adapted to the participants needs. Finally, the participants will evaluate the device provided through questionnaires and individual semi-structured interviews. This feedback will help assess the effectiveness of co-design and its feasibility to be incorporated into future NHS services.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Swansea, SA6 6NL, United Kingdom
PROCEDURE:
1.1 Arrange appointment: The principal investigator will telephone the potential participant to arrange an appointment to discuss their involvement in the research and gain consent. The consent form will be sent out to the participant (email or posted, depending on preference of participant).
Following the appointment, the researcher will make design alterations, manufacture designs and post prototypes out for the participant to try. Appointments will be 2-3 weeks apart.
SETTING:
Due to COVID-19 pandemic, where possible the majority of appointments with occur virtually using a video consultation programme called Attend Anywhere. This will include assessing eligibility and gaining consent, initial assessment, follow-up appointments and the semi-structured interviews. Information on how to access an appointment through this will be provided to participants when they are invited to their first appointment.
Between appointments, the researcher will contact participants using telephone or email to arrange subsequent appointments. During the study, any devices for the participant to trial will be posted out to them. Training and/or instructions will be provided on how to use the device prior to it being sent out.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the initial session the researcher will work with the participants to identify challenges in daily living for the device to overcome.
In between sessions the researcher will design and manufacture different solutions which will then be sent out for the participant to trial. The participant will then meet with the researcher to and feedback on the device provided. Feedback from the user is used to alter and improve the design of the device; new device(s) are then , enabling the design to be adapted to the participants needs. The process of design changes and feedback forms an iterative loop. This is expected to continue for 4-5 appointments over a period of serveral months until a final design is agreed upon.
After the device is issue, both qualitative and quantitative outcome measures are provided to participants to complete, including questionnaires and semi-structured interviews. .
Time frame: At initial device issue and at 3-months post device issue
Semi-structured questions will be used in individual interviews to facilitate an understanding of:
Time frame: At initial device issue and repeated at 3-months post device issue
A 12-item outcome measure that assesses the user's satisfaction with both the device and service provided in supplying the device. For each item of the questionnaire, a 5-point scale is used, 1 being not satisfied at all and 5 being very satisfied.
Time frame: At initial device issue and repeated at 3-months post device issue
A 26-item self-reported questionnaire to assess the effects of an assistive device on three sub-scales: competence, adaptability and self-esteem. For each item of the questionnaire, a 7-point scale is used, ranging from -3 (maximum negative impact) to 3 (maximum positive impact)
Time frame: At initial appointment and repeated at initial device issue
An instrument to assess the effectiveness of assistive technology provision in relation to activities the individual considers most relevant. The participant can select up to 7 problems they experience in everyday life. For each problem the participant assigns two scores, one for the importance of the activity and the second for the difficulty. Both scores are assigned using a 5 point scale: 1 not important to 5 most important and 1 not difficult to 5 too difficult to perform.
Time frame: Completed at the initial assessment and again at the 3-month follow-up assessment
A tool used to capture and record information on health and social care services and resources used by study participants to help estimate the costs of services received. It will be used to calculate the economic cost changes associated with participation in the study.
The inventory asks participants to idenfify the healthcare services they have accessed in the previous 3 months and any medication they are taking relevant to the health condition and challenges of daily living identified. It will also capture demographic information about the participants. The CRSI will measure any changes to services accessed, medication taken and demographic information as a result of participating in this study.
Time frame: Through study completion, an average of 8 months.
For each participant an estimate of the resources used and costs involved will be calculated. Costs will be calculated based on the number of person-hours required to engage participant and produce device, manufacturing time and material cost of all components required to produce the final device. This will include time for each appointment with the participant, time spent developing and changing the design, and time to create documentation required to comply with quality management system.
Swansea University
Other
Co-designing Personalised Aids of Daily Living With Users With Chronic Conditions: a Feasibility Study
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