Care augmentation by location-linked messaging
| ISRCTN | ISRCTN71271888 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71271888 |
| Secondary identifying numbers | 17557 |
- Submission date
- 08/01/2015
- Registration date
- 12/01/2015
- Last edited
- 14/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Motor neurone disease (MND) is a rare condition that progressively damages parts of the nervous system, causing muscle weakness. People with MND may attend an A&E department if they become unexpectedly unwell. The most common reason for this is a chest infection, and the A&E staff may provide standard treatment, consisting of oxygen and antibiotics. This is not always the correct thing to do for someone with MND because oxygen can make breathing more difficult in some situations. The A&E staff will usually try to admit the person to a hospital ward, again because this is standard treatment, but for someone with MND it may be better to be treated at home or in the local hospice. If the specialist MND team, a neurologist or the patient's GP could be involved, treatment could be better tailored to the patient, with a safer and better outcome. In this study we are testing a smartphone app running on the Android system to alert medical staff from the MND specialist team, the local neurologist or palliative care specialist, or GP that someone with MND has arrived in the A&E department, so that they can contact the A&E team and provide advice if necessary. All studies of MND done so far rely on a snapshot of someone seen on a particular day in a hospital. They do not tell us much about what is happening outside the hospital, which is what really matters. We do not know how our measures of how much MND affects someone when we see them in clinic compare with how MND really affects them at home. In this study we also hope to gather this extra information in order to learn more about this.
Who can participate?
Patients aged 18 or over with MND
What does the study involve?
Participants are randomly allocated to one of two groups. One group receive standard care including regular three monthly visits to the King's Motor Nerve Clinic. The other group use a smart phone with the built in app. The app detects when participants are in an A&E department and sends an automated message to the study team. Participants also use the app to perform some tests to provide information on speech, mobility, strength and sleep in between clinic appointments.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
King's College London (UK)
When is the study starting and how long is it expected to run for?
January 2014 to December 2020
Who is funding the study?
Motor Neurone Disease Association (UK)
Who is the main contact?
Prof. Ammar Al-Chalabi
Contact information
Scientific
King's College London
Institute of Psychiatry
P043, 16 De Crespigny Park
London
SE5 8AF
United Kingdom
Study information
| Study design | Randomised; Interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Assessment of Care Augmentation by Location-Linked MEssaging in amyotrophic lateral sclerosis with respiratory impairment compared with current standard care |
| Study acronym | CALL-Me |
| Study hypothesis | To use a custom-designed location detecting smartphone app to send predefined text messages to pre-specified individuals on arrival of a patient with ALS in an A&E department to allow advice, education and intervention to be targeted, and avoidance of the morbidity and mortality associated with high dose oxygen, and monitor patient disability between clinic visits. |
| Ethics approval(s) | 13/LO/1544 |
| Condition | Amyotrophic lateral sclerosis |
| Intervention | A smartphone running the Android operating system will be loaded with a custom designed app specifically designed to send text messages to predefined members of the patient's care team when the phone is detected in an A&E department for more than 15 minutes. The app will be loaded and programmed by HW Communications Ltd (www.hwcomms.com, Lancaster, UK) with A&E departments specified in conjunction with the patient, and text messages specified in conjunction with the ALS team at King's, the patient's GP and the patient's local specialist ALS care team. The recipients of the text messages and a person-specific message will be derived by examination of an online calendar, allowing for different team members to be contacted at different times of day, or during absences. The text content will also include the patient name, the name of the A&E department they are in and an automated call facility, allowing contact by the text message recipient with the A&E department through a simple on-screen button. |
| Intervention type | Other |
| Primary outcome measure | Number of inappropriate hospital admissions from A&E, in ALS patients, at 12 months |
| Secondary outcome measures | 1. Reduction in morbidity or mortality associated with high dose oxygen use in ALS will be measured by determining the difference between arms of the number clinical incidents associated with high dose oxygen use 2. Tolerability of the smartphone app system in participants of the intervention arm will be compared at 3, 6, 9 and 12 months, for user and app generated data 3. Feasibility will be measured by the differences between user and App generated logs of A&E visits at 3, 6, 9 and 12 months and examination of the quality and usability of disease-progression data collected |
| Overall study start date | 15/01/2014 |
| Overall study end date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Total final enrolment | 20 |
| Participant inclusion criteria | 1. Diagnosis of ALS 2. Subjects of either sex aged 18 years or over 3. Stage 3 or 4 ALS 4. Capable of understanding the information given and giving fully informed consent prior to any study specific procedures 5. Willing for the study team to contact patient’s GP about the study |
| Participant exclusion criteria | 1. Patients at high risk of A&E admission for respiratory care unrelated to ALS because of underlying respiratory disease 2. Any patient involved in another study in which an intervention is designed to improve diaphragmatic function 3. Refusal of palliative care 4. Impaired cognition as judged by clinician |
| Recruitment start date | 01/06/2017 |
| Recruitment end date | 28/02/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SE5 8AF
United Kingdom
Sponsor information
University/education
Institute of Psychiatry
Department of Psychology
Henry Wellcome Building
Box PO77
16 De Crespigny Park
London
SE5 8AF
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- MND Association, MNDA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/12/2022: The following changes have been made:
1. The recruitment start date has been changed from 15/01/2014 to 01/06/2017.
2. The recruitment end date has been changed from 14/01/2017 to 28/02/2019.
3. The overall trial end date has been changed from 14/01/2017 to 31/12/2020 and the plain English summary updated accordingly.
4. The intention to publish date has been added.
5. The final enrolment number has been added.
16/06/2016: Plain English summary added.
