The MONARCH study
Research type
Research Study
Full title
Monitoring for neovascular Age-related macular degeneration (AMD) Reactivation at Home: The MONARCH study
IRAS ID
232253
Contact name
Ruth Hogg
Contact email
Sponsor organisation
Queen's University Belfast
ISRCTN Number
ISRCTN79058224
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Summary of Research
Wet age-related macular degeneration (AMD) is the commonest cause of blindness in the UK. Providing prompt access to clinics for regular surveillance and treatment has proved a major challenge for the NHS. Most patients need a series of injections followed by a period of regular check-ups in case more injections are required. Wet AMD can often flare up after a period when treatment has not been required and check-ups are usually needed for several years.Vision tests completed by patients themselves at home (we call these "home monitoring" tests) to detect the need for treatment could mean that patients would not need regular hospital check-ups, allowing clinic appointments to be kept for patients likely to require treatment. Home monitoring would be more convenient and less costly for both the patient and the NHS.
The main aim of our study is to find out whether our chosen home monitoring tests can detect when wet AMD needs to be treated as well as the tests currently carried out at hospital check-ups.
We will evaluate three home monitoring tests; a paper booklet and two vision test software applications (MultiBit test and MyVisionTrack®) that run on an iPod touch.
We will recruit approximately ≥400 participants from 5 hospitals who will be asked to perform the home monitoring tests weekly for both eyes at home in between their standard hospital check-ups over a period of 1-2 years. All equipment will be provided and every other aspect of care will stay the same. The home monitoring test results will not be known by patient's hospital care teams.
We are also investigating the acceptability of home monitoring to both participants and their carers at 3 of the 5 hospitals. We will interview a sample of participants and carers in their homes and by telephone or Skype.
Summary of Results
What was the question?
Treatment for neovascular age-related macular degeneration, the most common cause of sight loss in those over 50, involves regular eye injections and frequent follow-up appointments. This is inconvenient for patients and causing capacity issues in the hospital eye service. Finding tests that could be undertaken at home that could detect if a further injection and hospital appointment was required or not would increase capacity to see those at highest risk of sight loss and also reduce the burden on patients and their carers.
What did we do?
We investigated 3 different visual function tests, one paper-based and two applications on an iPod touch tablet. We wanted to see if they could detect an increase in disease activity that would require treatment, compared to the decision by a retinal specialist at a traditional hospital eye outpatient visit based on clinical examination and retinal imaging. To encourage those without a smartphone or home internet to participate we provided both an iPod touch and MiFi device with a mobile contract.
What did we find?
None of the tests performed well enough to safely monitor patients at home. Those who were willing to participate tended to be younger, had previous experience of using smartphones, sending email and internet access and were more well-off than those who chose not to participate. Some participants also experienced difficulties with the devices provided and successfully uploading the data which was not related to the extent of previous information technology experience. There were also significant technical challenges for the research team. The study helpline was used heavily, considerably more than we anticipated.
What does it mean?
These tests are not ready to be used in this context. Future studies involving mobile health technology need to carefully consider how to reach those unlikely to participate and provide sufficient technical support to support long-term follow-up. The summary should be written in Plain English. Technical terms should be explained and acronyms described in full. Further guidance is available on the HRA website. It is not possible to upload files or graphics but you can include URL links.Scientific summary of study results –
Background: Most neovascular age-related macular degeneration (nAMD) treatments involve long-term follow-up of disease activity. Home-monitoring would reduce the burden on patients and those they depend on for transport, and release more clinic appointments for other patients. The MONARCH study aimed to evaluate three home-monitoring tests for patients to use to detect active nAMD compared to diagnosis of active nAMD by hospital follow-up.
Objectives:
There were five objectives:
A. Estimate the accuracy of three home-monitoring tests to detect active nAMD.
B. Determine the acceptability of home-monitoring to patients and carers and adherence to home-monitoring.
C. Explore whether inequalities exist in recruitment, participants’ ability to self-test, and their adherence to weekly testing during follow-up.
D. Provide pilot data about the accuracy of home monitoring to detect conversion to nAMD in fellow eyes of patients with unilateral nAMD.
E. Describe challenges experienced when implementing the tests.
Design: Diagnostic test accuracy cohort study, stratified by time since starting treatment.
Setting: Six UK Hospital Eye Service (HES) Macular Clinics (Belfast, Liverpool, Moorfields, James Paget, Southampton, Gloucester).
Participants:
Patients with at least one study eye being monitored by hospital follow-up.
Reference standard:
Detection of active nAMD by an ophthalmologist at hospital follow-up.
Index tests:
1. KeepSight Journal (KSJ): paper-based booklet of near vision tests presented as word puzzles.
2. MyVisionTrack® (mVT®): electronic test, viewed on a tablet device.
3. MultiBit (MBT): electronic test, viewed on a tablet device.
Participants provided test scores weekly. Raw scores between hospital follow-ups were summarised as averages.
Results: 297 patients (mean age 74.9 years) took part. At least one hospital follow-up was available for 317 study eyes (1,549 complete visits). Median testing frequency was 3 times per month. Estimated areas under receiver operating curves (AUROCs) were <0.6 for all index tests, and only KSJ summary score was significantly associated with the lesion activity (OR=3.48, 95% confidence interval 1.09-11.13, p=0.036). Older age and worse deprivation for home address were associated with lower participation (chi-squared=50.5 and 24.3 respectively, both p = <0.001) but not ability or adherence to self-testing. Estimated AUROCs were higher for conversion of fellow eyes to nAMD (0.85 for KSJ). Almost half of participants called a study helpline, most often due to inability to test electronically.
Limitations: Pre-specified sample size not met; participants’ difficulties using the devices; electronic tests not always available.
Conclusions:
No index test provided adequate test accuracy to identify lesion activity as diagnosed in follow-up clinics. Associations of older age and worse deprivation with study participation highlights the potential for inequities with such interventions. Provision of reliable electronic testing was challenging.
Future work:
Future studies evaluating similar technologies should consider:
(i) Independent monitoring with clear stopping rules based on test performance.
(ii) Deployment of apps on patients own devices since providing devices did not reduce inequalities in participation and complicated home-testing.
(iii) Consider alternative methods to summarise multiple scores over the period preceding a follow-upREC name
HSC REC A
REC reference
17/NI/0235
Date of REC Opinion
29 Jan 2018
REC opinion
Further Information Favourable Opinion