Investigating digital follow-up monitoring for long-term stable blood conditions
| ISRCTN | ISRCTN15125462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15125462 |
| IRAS number | 301109 |
| Secondary identifying numbers | IRAS 301109, CPMS 55852 |
- Submission date
- 02/08/2023
- Registration date
- 11/09/2023
- Last edited
- 04/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This is an investigation into a new way of keeping in touch with patients with long-term stable blood conditions. Currently, these patients have to attend a clinic (in person or by telephone) every 6 months to check for any changes in their condition, which imposes on their routines and takes up valuable time for doctors and nurses. Instead, we will invite these patients to download a new app, which they can use to track their condition, view blood test results, and report any new symptoms for review by a clinician.
Who can participate?
This study is open to patients with eight different blood conditions in long-term stable follow-up and under the care of a participating Trust. These conditions are: chronic lymphocytic leukemia (CLL), haemochromatosis, iron-deficient anaemia, myelodysplastic syndromes (MDS), monoclonal gammopathy of uncertain significance (MGUS), smouldering/asymptomatic myeloma, sickle cell disease (SCD), Waldenstrom’s macroglobulinemia.
What does the study involve?
This study is broken into several Arms. Some of these Arms use only existing patient information, gathered as retrospective anonymised data, or only recruit clinical staff, in order to include doctors’ and nurses’ perspectives. Those Arms that include patients are Arm 1 and Arm 5. In Arm 1, patients are recruited to participate in focus groups, interviews, and User Experience Testing, in order to help design the Ascelus app. Arm 5 will involve a large number of patients downloading the app to track their condition over the course of a year. The researchers will gather safety information from these patients directly via the app, and will also use the app to send them surveys and questionnaires regarding their quality of life and healthcare resource utilisation during the 12 months.
What are the possible benefits and risks of participating?
The benefits and risks of participation differ between Arms 1 and 5. For patients participating in Arm 1, the benefits will include space to think about existing follow-up processes, and how these could be different; there are very few risks, although participation will involve dedicating some time to the discussion. For patients participating in Arm 5, it is hoped that the Ascelus app will save time, provide reassurance through blood test reviews, and facilitate ease of reporting new symptoms. This arm will also involve making time available for questionnaires and focus groups, and there is a small additional risk that standard of care will be impacted should the app prove difficult to use. Because both Arms involve the collection of data, there are risks around the security of data storage. However, the researchers have made every effort to minimise these risks – no one outside of their existing care team will access participants' confidential records, and all new records created will be anonymous, so they cannot be identified from them.
Where is the study run from?
King’s College Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2022 to April 2024
Who is funding the study?
Itecho Health (UK)
Who is the main contact?
Samiha Tahsin
Contact information
Principal Investigator
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)7989405488 |
|---|---|
| reubenbenjamin@nhs.net |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Other |
| Study type | Quality of life, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A multi-centre investigation of the use of a digital follow-up pathway utilising the Ascelus app for monitoring long-term blood conditions, incorporating patient, carer, and healthcare professionals co-design and evaluation, clinical validation, and safety investigations |
| Study acronym | Ascelus-H |
| Study objectives | This is a multi-centre prospective observational study of patients with long-term haematological conditions on a new digital follow-up pathway utilising the Ascelus platform. We are exploring this digital follow-up pathway as a means of better prioritising clinic time (both face-to-face and telephone/virtual) whilst giving long-term stable patients a less invasive means of tracking and reporting their condition. |
| Ethics approval(s) |
Approved 02/08/2022, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Newcastle Upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8141; leedswest.rec@hra.nhs.uk), ref: 22/YH/0149 |
| Health condition(s) or problem(s) studied | Chronic lymphocytic leukemia (CLL), haemochromatosis, iron-deficient anaemia, myelodysplastic syndromes (MDS), monoclonal gammopathy of uncertain significance (MGUS), smouldering/asymptomatic myeloma, sickle cell disease (SCD), Waldenstrom’s macroglobulinemia |
| Intervention | This study has five arms: Arm 1 – Patient and carer co-design, collecting qualitative data on patient satisfaction and empowerment on follow-up pathways, via focus groups and individual interviews Arm 2 – Healthcare professionals co-design and feedback, collecting qualitative data on healthcare professionals' views and feedback on the digital follow-up pathways, via focus groups and interviews Arm 3 – Key Opinion Leader (KOL) interviews, investigating issues of implementation, scalability, and commercialisation in the app design phase and in the post-implementation review phase Arm 4 – Retrospective clinical review of patients on face-to-face, telephone, and virtual follow-up pathways in the 12 months prior to digital pathway commencement, and at 6 and 12 months post-implementation, collecting data on patient safety and outcome measures Arm 5 – Patient group on the new digital pathway, participating in outcome, quality of life, and patient empowerment data collection measures (questionnaires, interviews, and data gathered from existing patient records) Arms 1, 2, and 3 are qualitative co-design and implementation feasibility studies, utilising focus groups and individual interviews alongside User Experience testing (eye-tracking tests of the Ascelus app). An interpretative approach will determine patients’, carers’ and clinicians' perspectives to inform analysis. User experience testing will proceed with data analysis of participant laboratory sessions from the eye-tracking software used in each of the sessions. Arm 4 is a retrospective clinical review of patients from relevant disease groups on existing face-to-face, telephone, and virtual follow-up pathways in the 12 months prior to digital pathway commencement. Quantitative measures of clinical safety and patient satisfaction will be gathered via a review of routine data gathered by existing Trust mechanisms (e.g. complaint reporting). Arm 5 is the app users quality of life cohort. Participants will complete outcome, quality of life, and patient empowerment data collection measures (questionnaires, interviews, and data gathered from existing patient records). |
| Intervention type | Other |
| Primary outcome measure | Patient satisfaction, empowerment, and quality of life on a new digital follow-up pathway, using EQ5D and PAM-13 questionnaires at baseline, 6, and 12 months following enrolment, alongside focus groups and interviews at 6 months following enrolment |
| Secondary outcome measures | 1. Safety of the digital follow-up pathway, using progression and adverse incident data taken from clinical records. This will be measured retrospectively for the cohort in the 6 months prior to enrolment, and at 6 and 12 months following enrolment 2. Cost-effectiveness of the digital follow-up pathway when compared to face-to-face and telephone appointments, using a detailed Healthcare Resource Utilisation survey taken at baseline, 6, and 12 months following enrolment 3. Healthcare professionals' satisfaction with the digital follow-up pathway, using clinician focus groups prior to app implementation and at 6 months following patient enrolment |
| Overall study start date | 01/04/2022 |
| Completion date | 01/04/2024 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 2440 |
| Key inclusion criteria | Inclusion for Arm 1: Patient/carer with a relevant condition at a participating Trust Inclusion for Arm 2: Healthcare professionals or other healthcare professional in relevant discipline Inclusion for Arm 3: Healthcare professional in a relevant discipline or with a relevant special interest Inclusion for Arm 4: 1. Diagnosis with a relevant stable condition 2. 16 years of age or older at the start date for data collection 3. Under the care of a participating Trust Inclusion criteria for Arm 5: 1. Diagnosis with a relevant stable condition 2. 16 years of age or older at the study start 3. Under the care of a participating Trust 4. Able to access and use the Ascelus platform |
| Key exclusion criteria | Exclusion for Arms 1 - 4: None Exclusion for Arm 5: Presence of co-morbidities that would require regular review in the clinic |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 01/02/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE5 9RS
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Sponsor information
Hospital/treatment centre
Denmark Hill
London
SE5 9RS
England
United Kingdom
| Phone | +44 (0)203 299 6625 |
|---|---|
| rahman.ahmed1@nhs.net | |
| Website | https://www.kch.nhs.uk/ |
"ROR" |
https://ror.org/044nptt90 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The patient studies to which this protocol applies are part of an overall project supported by the NIHR Invention for Innovation (i4i) Challenge scheme. This is a translational research funding scheme, only available to SMEs as lead investigators, aimed at de-risking early-to-late stage medical devices, in vitro diagnostics and high-impact patient-focused digital health technologies for ultimate NHS use. As such, it is recognised that ownership of the data rests with the lead SME (Itecho Health Ltd) and that there may be confidentiality and commercial issues, which can only be properly judged by Itecho Health Ltd, which will make the final judgement on the timing and nature of the dissemination and publication processes. Nevertheless, the importance of publication and dissemination is fully recognised. The success of the clinical study depends upon the collaboration of all participants. For this reason, credit for the main results will be given to all those who have collaborated in the study, through authorship and contributorship. Uniform requirements for authorship for manuscripts submitted to medical journals will guide authorship decisions. These state that authorship credit should be based only on substantial contribution to: 1. Conception and design, or acquisition of data, or analysis and interpretation of data 2. Drafting the article or revising it critically for important intellectual content 3. Final approval of the version to be published. To accompany this policy the collaborators are developing a publication and dissemination strategy as a way to optimise opportunities to publish data and share learning from the project, which is consistent with NIHR priorities. |
| IPD sharing plan | The datasets gathered during the current study are not expected to be made available, due to the consent conditions that the patients have agreed to. |
Editorial Notes
04/10/2023: Internal review.
03/08/2023: Study's existence confirmed by the Yorkshire & The Humber - Leeds West Research Ethics Committee.
