Evaluating the acceptability and usability of a digital self-management intervention (smartphone application) to support the non-surgical treatment of Perthes' Disease
| ISRCTN | ISRCTN14517832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14517832 |
| IRAS number | 330507 |
| Secondary identifying numbers | IRAS 330507, CPMS 59738 |
- Submission date
- 20/10/2023
- Registration date
- 19/12/2023
- Last edited
- 22/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Perthes’ disease is a condition that results in the collapse of a child’s hip bone, affecting their ability to run, and play sports and some children even find walking difficult. There is lots of uncertainty around the treatment of Perthes’ disease and a lack of consistent advice between Perthes’ disease specialists. This can cause considerable anxiety to the parents of children with Perthes’ disease. With the support of children with Perthes’ disease, their families and clinicians, a digital intervention (an app) has been developed. This is the final study within an overarching project to test an app, designed to support self-management.
Who can participate?
Children aged between 5 and 16 years old who were diagnosed with Perthes’ Disease between one and five years ago
What does the study involve?
The study will recruit ten children from three sites (30 total) to use the app for six weeks. Information will be collected before and after using the app, focussing on app usage, quality of life and impact of the condition on the child/family. The study will also test how acceptable the app is to children with Perthes’ disease and their families. There will also be a sub-study where some participants will be asked more specific questions about their interaction with the app to gain insight into the reasons why different elements of the app were/were not as acceptable as others. 12-15 of the participants who used the app will be invited to take part in focus groups to discuss their experience of using the app in more detail.
The results of this study will be shared so that it is accessible to all. Articles will be published in medical journals and information will be shared with groups who support children with Perthes’ disease, as well as through social media. The results will be fed back in a ‘fun’ child-friendly way, using videos and electronic leaflets to make sure the answers are available to everyone.
What are the possible benefits and risks of participating?
There are no significant benefits or risks to taking part in this study. The benefit of taking part is that the participants will have an opportunity to try a novel intervention in the management of a debilitating condition and provide insight that could improve the care of children with the condition in the future. The main risk is the burden of time for the participants taking part, to account for this, funding has been acquired in line with NIHR guidance to compensate participants for their time.
Where is the study run from?
University of Leeds (UK)
When is the study starting and how long is it expected to run for?
June 2023 to May 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Mr Adam Galloway, adamgalloway@nhs.net (UK)
Contact information
Public, Scientific, Principal Investigator
University of Leeds
Leeds
LS1 3EX
United Kingdom
 ORCID ID |
0000-0002-6093-7669 |
|---|---|
| Phone | +44 (0)113 3926610 |
| adamgalloway@nhs.net |
Study information
| Study design | Mixed methods with observational and qualitative components |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Nested-qualitative |
| Study setting(s) | Home, Hospital |
| Study type | Other |
| Participant information sheet | 44459_PIS[App_Child]_v1.2.pdf |
| Scientific title | Evaluating the acceptability and usability of a digital self-management intervention (smartphone application) to support the non-surgical treatment of Perthes' Disease |
| Study acronym | Testing the NON-STOP app |
| Study hypothesis | 1. To test the acceptability of implementing the NON-STOP intervention with children with Perthes’ Disease and their families 2. Understand the user experience of children with Perthes’ Disease when using the NON-STOP intervention |
| Ethics approval(s) |
Approved 30/11/2023, West Midlands Research Ethics Committee (Meeting held by video-conference via Zoom, -, -, United Kingdom; +44 (0)207 104 8357; edgbaston.rec@hra.nhs.uk), ref: 23/WM/0251 |
| Condition | Perthes' Disease |
| Intervention | Testing of a new self-management intervention to support management |
| Intervention type | Other |
| Primary outcome measure | Log-ins, type of data accessed, and time used measured using App use metrics at the end of the study |
| Secondary outcome measures | 1. Physical health function measured using the Patient-Reported Outcomes Measurement Information System: Mobility tool (PROMIS Mobility including QoL assessment) before and after app use 2. Child activity levels measured using the Child Physical Activity Questionnaire (CPAQ) pre and post-app testing period 3. App acceptability measured using the Health Information Technology Usability Evaluation Scale (Health-ITUES) after the app testing period |
| Overall study start date | 01/06/2023 |
| Overall study end date | 31/05/2024 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 30 |
| Participant inclusion criteria | 1. Diagnosed with Perthes’ Disease between one and five years ago 2. Aged between 5 and 16 years old 3. Access to a smart device |
| Participant exclusion criteria | 1. Unable to communicate verbally in English 2. The child has undergone surgery for Perthes’ Disease in the last 6 weeks |
| Recruitment start date | 02/01/2024 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds
LS1 3EX
United Kingdom
Sponsor information
University/education
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| Phone | +44 (0)113 3437587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact and peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository from the lead researcher's institute (University of Leeds) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 14/11/2023 | No | Yes | |
| Participant information sheet | version 1.2 | 14/11/2023 | No | Yes | |
| Participant information sheet | nested qualitative study version 1.2 |
14/11/2023 | No | Yes | |
| Participant information sheet | nested qualitative study version 1.2 |
14/11/2023 | No | Yes | |
| Protocol file | version 1.0 | 14/11/2023 | No | No |
Additional files
- 44459_PIS[App_Child]_v1.2.pdf
- 44459_PIS[App_family]_v1.2.pdf
- 44459_PIS[Qual_child]_v1.2.pdf
- nested qualitative study
- 44459_PIS[Qual_family]_v1.2.pdf
- nested qualitative study
- 44459_Protocol_v1.0.pdf
Editorial Notes
22/12/2023: Ethics approval added.
23/10/2023: Trial's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).
