Clinical trial NCT04836624: Co-designing Personalised Assistive Technology
Official title: Co-designing Personalised Aids of Daily Living With Users With Chronic Conditions: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability or Chronic Disease Leading to Disablement
Keywords: Co-design
Assistive technology
Assisitve Device
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: Swansea Bay University Health Board
First posted: 2021-04-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: PROCEDURE:

1. Referral: Potential participants will be identified by a healthcare professional from their current care team and asked whether they would like to participate in the study. Potential participants will be provided with the participant information sheet and asked to consent if they would like their details to be referred onto the principal investigator.

   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).
2. Consent and eligibility \[Virtual appointment\]: The principal investigator will go through the participant information sheet with the participant and answer any questions they have about the study. The researcher will check they are eligible to take part in the study. If the participant is happy to be involved, they will be asked to sign the consent form and return it back to the researcher (either by email or posting back).
3. Initial assessment \[Virtual appointment\]: Through discussion with the participant, the researcher will gather relevant information to help identify their assistive technology needs. This will include information about their medical history and social context, likes and dislikes, current and any previous solutions used and challenges they faces in daily living. For each challenge identified, participants will be asked to score 1-5 about how important the challenge is to them and how difficult it is. This is for the Individually Prioritised Problem Assessment (IPPA) base-line measure. The researcher will complete the Client Service Receipt Inventory base-line measure with the participant to capture demographic information, information on heathcare services accessed in the previous 3 months and medication being taken.
4. Follow-up appointments, approximately 3-5 \[Predominantly virtually, with face-to-face only if required\]: In subsequent appointments the participant will meet with the researcher to discuss design ideas, provide feedback and agree on design changes for the devices(s) provided by the researcher to the participant. The participant will be asked to describe what they like/dislike about the current design and what changes they would make. The researcher may show design prototypes over video call to demonstrate how a device will work and to help facilitate gathering feedback.

   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.
5. Device issue: Once the design has been refined to a level the participant and researcher are happy with, a final solution will be manufactured. The device will be sent out to the participant and the researcher will meet virtually with the participant to provide any necessary training and instructions for safe usage of the device.
6. Outcome measures \[Virtually, same appointment as above\]: The researcher will explain and go through the three different questionnaires being used as outcome measures for the study. The participant will be asked to score 1-5 the difficulty they now find the previously identified challenges (from initial assessment). For the two other measures, QUEST and PIADS \[explained below\], the researcher will either email or post out the questionnaires to the participant, preference of participant. Participants will be asked to complete and send back (email/post) once completed. Participants will be invited to complete the first of the semi-structured interviews with the researcher to obtain feedback on the co-design process and the device provided. Prior to beginning the interview, participants will be reminded it will be audio-recorded. If required, an additional appointment can be arranged to help the participant complete the questionnaires.
7. Three month follow-up feedback \[Virtual appointment\]: Participants will be invited to again complete and return the two questionnaires, QUEST and PIADS, to the researcher. Participants will complete the follow-up CSRI with the researcher. Participants will also be invited to undertake the second semi-structured interview to obtain feedback on the long-term use of device provided. Prior to beginning the interview, participants will be reminded it will be audio recorded Upon completion of the interview the participants involvement in the study will finish. Participants will be advised to contact the Rehabilitation Engineering Unit with any issues with their devices or further queriers about the research.

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of a long-term chronic condition
* Living in the community
* Age eighteen years or older
* Ability to actively engage in a co-design process, as determined by the referring clinician, including:
* Sufficient comprehension of language to engage in meaningful verbal dialogue with the researcher.
* Sufficient insight into their condition such that they understand their needs.
* Sufficient ability to communicate their needs.
* Sufficient ability to retain information between sessions
* Currently under the care of healthcare services within Swansea Bay University Health Board
* At least three-month post injury/diagnosis at the point of recruitment allowing time for spontaneous recovery and for the person to become aware of their difficulties and the implications of this on their lives

Exclusion Criteria:

* Receptive or expressive language difficulties, or extremely low memory function that may preclude people from engaging meaningfully
* Medically unstable, severe mental health or cognitive difficulties which may preclude meaningful engagement in the study.
* Not able to provide informed consent.
* Have insufficient access to the internet to engage virtually with the researcher through video conferencing software.

Primary outcomes:
measure: Qualitative Feedback - Semi-structured interviews
timeFrame: At initial device issue and at 3-months post device issue
Secondary outcomes:
measure: Quebec User Evaluation of Satisfaction with Technical Aids (QUEST 2.0)
timeFrame: At initial device issue and repeated at 3-months post device issue
measure: Psychosocial Impact of Assistive Devices Scale (PIADS)
timeFrame: At initial device issue and repeated at 3-months post device issue
measure: Individually Prioritised Problem Assessment (IPPA)
timeFrame: At initial appointment and repeated at initial device issue
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Completed at the initial assessment and again at the 3-month follow-up assessment
Other outcomes:
measure: Resources used
timeFrame: Through study completion, an average of 8 months.
Locations:
city: Swansea
country: United Kingdom
facility: Swansea Bay University Health Board
Study officials:
affiliation: Swansea University
name: Jonathan Howard, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: