A smartphone app to measure day-to-day changes in hand symptoms
| ISRCTN | ISRCTN19841416 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19841416 |
| IRAS number | 302403 |
| Secondary identifying numbers | CPMS 51091, IRAS 302403 |
- Submission date
- 31/12/2021
- Registration date
- 17/02/2022
- Last edited
- 15/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Patient-reported outcome measures (PROMs) are questionnaires that measure important elements of health. In hand surgery, PROMs are used to measure health constructs such as pain and hand function. This can be important in clinical practice, to tell whether an intervention (e.g. an operation or hand therapy) has made somebody feel better, or in research to compare how effective different interventions are. A problem with PROMs is that we usually only ask patients to complete them at infrequent and arbitrary time points (e.g. before surgery, at 6 weeks and again at 3 months). This means that day-to-day changes in symptoms are often missed. This is particularly important in arthritis and hand injuries, where symptoms can be brought on by certain activities, and even affected by the weather.
We plan to test a new technique to collect PROM responses more frequently. It is called Ecological Momentary Computerised Adaptive Testing (EMCAT). EMCAT works by using “artificial intelligence” to make PROM questionnaires much shorter and tailored to an individual, based on their previous responses. By making PROMs shorter, we think that people could complete them at frequent time points (e.g. every day) by using a smartphone application. This will help us capture day-to-day changes in symptom severity.
Who can participate?
People who have had a hand injury, and people who have hand arthritis
What does the study involve?
We are going to test a smartphone application that uses EMCAT. To see if people like using it, we will check how frequently they used it and interview them about their experience. This information will help us to make the application better, so that we can test it in a large-scale study at a later date.
What are the possible benefits and risks of participating?
There are no significant risks to taking part in this study and no direct benefits to participants, but this work may go on to help patients with a range of conditions in the future.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
September 2020 to December 2022
Who is funding the study?
The British Society for Surgery of the Hand, the Federation of European Societies for Surgery of the Hand, and AOUK
Who is the main contact?
Conrad Harrison, conrad.harrison@medsci.ox.ac.uk
Contact information
Scientific
The Botnar Research Centre
University of Oxford
Old Road
Headington
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0000-0002-1428-5751 |
|---|---|
| Phone | +44 1865 227 374 |
| conrad.harrison@medsci.ox.ac.uk |
Study information
| Study design | Observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | The feasibility of ecological momentary computerised adaptive testing in hand surgery |
| Study hypothesis | The aim is to test Ecological Momentary Computerised Adaptive Testing (EMCAT) to take Patient-reported outcome measures (PROMs) more frequently. |
| Ethics approval(s) | Approved 19/12/2021, East of England - Cambridge East Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207 1048375; CambridgeEast.REC@hra.nhs.uk), ref: 21/EE/0261 |
| Condition | Hand surgery |
| Intervention | We will perform a mixed-methods pilot study of the PEM EMCAT platform. This will involve 40 participants engaging with the EMCAT app on their smartphones over a 12 week period. Following this, semi-structured interviews will be conducted with a maximum diversity sample of 10 participants. These will be recorded for thematic analysis. Engagement rates will be quantified for the whole sample of 40 participants. Sampling Strategy Initially, we will purposively select a maximum diversity sample of 20 participants undergoing treatment for thumbbase OA and 20 participants undergoing treatment for hand trauma. These participants will be recruited from Buckinghamshire NHS Trust and the Cardiff and Vale University Health Board. We will aim to diversify samples by age, sex, ethnicity, employment status, hand dominance and type of treatment. From each group, 5 participants will be purposefully sampled for semi-structured qualitative interviewing. We will aim to diversify these subgroups by the same variables. Methods of Data Collection Each of the 40 participants will be asked to download the EMCAT web-browser app onto their smartphones and enable push notifications. Where required, a member of the research team will assist with this. At pre-specified time schedules, participants will be sent a reminder to engage with the app via email and/or push notification. Three different time schedules will be tested: three notifications a day, one notification a day, and three notifications a week. When a participant receives a notification, they can choose to engage with the EMCAT app, or dismiss the notification. If the participant chooses to open the EMCAT app, they will be invited to complete a sample of items from the PEM part 2. We expect that participants will be asked to complete between 1 and 4 questions each time they are notified. PEM EMCAT responses will be collected for a period of 12 weeks. In addition to the PEM EMCAT, each participant will be asked to complete the full-length PEM part 2 questionnaire (11 items) at 0, 6 and 12 weeks via the app. At 12 weeks, we will also ask participants to complete the 31 item User Engagement Scale (UES), also via the app. Following the 12 week pilot period, we will select a maximum diversity sample of 5 participants with thumb-base OA and 5 participants with hand trauma for qualitative interviews. Semi-structured interviews will be conducted, and transcribed using the Zoom videoconferencing platform. Transcripts will then be manually de-identified. Interviews will follow a schedule that covers the following topics: - Perceived value of the EMCAT as a data-capture platform - Acceptability of EMCAT - Perceived burden of EMCAT - Facilitators and barriers to using EMCAT - Areas for improvement within the EMCAT platform - The potential for EMCAT’s use in remote monitoring and clinical decision support Participants will be given opportunity to discuss any other aspects of the EMCAT platform they consider important. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | EMCAT app |
| Primary outcome measure | 1. Response rates to EMCAT notifications across different scheduling regimes, measured using the app over 12 weeks 2. Attrition rate, recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 12 weeks, across different scheduling regimes |
| Secondary outcome measures | 1. User engagement, as measured by the User Engagement Scale at 12 weeks 2. Agreement of EMCAT scores and full-length PEM scores over 12 weeks 3. Number of items administered and standard error of measurement in each assessment, over 12 weeks 4. Explored using semi-structured interviews: 4.1 The perceived value of the EMCAT as a data-capture platform 4.2 The acceptability of EMCAT 4.3 The perceived burden of EMCAT 4.4 Facilitators and barriers to using EMCAT 4.5 Areas for improvement within the EMCAT platform 4.6 The potential for EMCAT’s use in remote monitoring and clinical decision support |
| Overall study start date | 25/09/2020 |
| Overall study end date | 07/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Total final enrolment | 40 |
| Participant inclusion criteria | 1. Participant aged over 18 years and undergoing treatment for recent hand trauma or thumb-base osteoarthritis (OA) 2. Able to provide informed consent 3. Able to download and use the EMCAT app onto a personal smartphone |
| Participant exclusion criteria | The participant may not enter the study if they have any communicative or cognitive barrier that would prevent them from engaging in the interview process |
| Recruitment start date | 01/01/2022 |
| Recruitment end date | 01/06/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Whielden Street
Amersham
HP7 0JD
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Sponsor information
University/education
University Offices
Oxford
OX1 2JD
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research council
No information available
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 05/12/2021 | 11/01/2022 | No | No |
| Protocol file | version 2.0 | 14/05/2022 | 19/05/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 14/09/2023 | 15/09/2023 | Yes | No |
Additional files
Editorial Notes
15/09/2023: Publication reference added.
06/06/2023: The following changes have been made:
1. The overall study end date has been changed from 01/06/2023 to 07/12/2022 and the plain English summary has been updated to reflect this change.
2. The total final enrolment was added.
19/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/06/2022 to 01/06/2023.
2. The overall trial end date has been changed from 01/06/2022 to 01/06/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/06/2023 to 01/06/2024.
4. The protocol (not peer reviewed) has been uploaded as an additional file.
31/12/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
