NCT04836624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 28, 2023

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

March 29, 2021

Last Update Submit

April 27, 2023

Conditions

Keywords

Co-designAssistive technologyAssisitve Device

Outcome Measures

Primary Outcomes (1)

  • Qualitative Feedback - Semi-structured interviews

    Semi-structured questions will be used in individual interviews to facilitate an understanding of: * Any change the device(s) provided have had on the participants life * Identify components of the co-design methodology that participants like and dislike and changes to it in the future. * If co-design has changed any of the barriers to accessing and using assistive technology

    At initial device issue and at 3-months post device issue

Secondary Outcomes (4)

  • Quebec User Evaluation of Satisfaction with Technical Aids (QUEST 2.0)

    At initial device issue and repeated at 3-months post device issue

  • Psychosocial Impact of Assistive Devices Scale (PIADS)

    At initial device issue and repeated at 3-months post device issue

  • Individually Prioritised Problem Assessment (IPPA)

    At initial appointment and repeated at initial device issue

  • Client Service Receipt Inventory (CSRI)

    Completed at the initial assessment and again at the 3-month follow-up assessment

Other Outcomes (1)

  • Resources used

    Through study completion, an average of 8 months.

Study Arms (1)

Co-designing personalised aids of daily living

EXPERIMENTAL

Participants will be involved in up to 6 interactive sessions spread over 3 months with the researcher. Participants will work with the researcher to help develop their own assistive device to overcome challenges of daily living they experience.

Device: Co-designing of personalised aids of daily living

Interventions

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. .

Co-designing personalised aids of daily living

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea Bay University Health Board

Swansea, SA6 6NL, United Kingdom

Location

Study Officials

  • Jonathan Howard, PhD Student

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 8, 2021

Study Start

May 10, 2021

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

April 28, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations