Open Using activity tracking and just-in-time messaging to improve adaptive pacing in people with long COVID: a pragmatic randomised control trial

Be Part Of Designing UWS [University of the West of Scotland] Research Into ME And Long COVID

"Researchers at the University of the West of Scotland (UWS) are undertaking research into ME and long COVID, and are looking for members of the ME community to be involved in the development.

The researchers are currently undertaking several studies related to long COVID, including symptom tracking and heart rate supported pacing. Some #MEAction Scotland volunteers spoke to the UWS team and they are clear that their focus is on pacing support and not incremental physical activity or any other variant of graded exercise therapy, as they are aware of the dangers for people who experience post-exertional symptom exacerbation."

https://www.meaction.net/2022/02/03/be-part-of-designing-uws-research-into-me-and-long-covid/

 

As I found the registry entry for the trial I have amended the thread title to match the trial. Interestingly, it seems that one of the exclusion criteria is having ME.

Study hypothesis

An activity tracking and personalised just-in-time adaptive intervention (JITAI) will reduce symptoms of post-exertional malaise (PEM) in people with long-COVID compared to usual care six months after ransdomisation.

Ethics approval
Approved 12/08/2021, University of the West of Scotland Health and Life Sciences Ethics Committee (Stephenson Place Hamilton International Technology Park Blantyre, Glasgow G72 0LH; no telephone contact provided ; gary.boyd@uws.ac.uk), ref:16638

Study design
Pragmatic single centre randomized controlled trial

Primary study design
Interventional

Secondary study design
Randomised controlled trial

Trial setting
Home

Trial type
Quality of life

Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.

Condition
Reducing frequency and severity of post-exertional malaise in people with long COVID.

Intervention
250 participants with long COVID will be randomised into intervention and control groups using a secure, independent online trial allocation service. Allocation will be stratified for age and sex.

125 Participants in the control group will receive standard advice on pacing and managing energy levels. Participants in the intervention group will receive an activity tracker and a bespoke mobile phone 'App'. Each day, using their activity tracking data intervention participants will receive individualised alert messages when they spend time above a specific HR determined activity threshold (eg. time above 130 bpm) and if they have not spent sufficient time at rest.

Intervention type
Behavioural

Phase


Drug names


Primary outcome measure
Post-exertional malaise using the PEM questionnaire at baseline and at 6 months.

Secondary outcome measures
1. PEM trend using PEM questionnaire assessed monthly
2. Depression trend using PHQ-9 monthy
3. Depression change using PHq-9 assessed at baseline and 6 months.
4. Fatigue trend using FSS monthly
5. Fatigue change using FSS at baseline and 6 months.
6. Quality of life trend using SF36 monthly
7. Quality of life change using SF36 at baseline and 6 months
8. Self-efficacy trend using Self Efficacy Scale monthly
9. Cognitive function using a variation of the symbol digit modalities test monthly
10. Cognitive function using a variation of the symbol digit modalities test at baseline and 6 months.
11. Pain using Pain VAS assessed at baseline and 6 months
12. Pain trend using Pain VAS assessed monthly between months 0-6
13. Resting heart rate assessed daily using the activity tracker

Overall trial start date
16/07/2021

Overall trial end date
31/12/2022

Reason abandoned (if study stopped)


Eligibility
Participant inclusion criteria
1. Adults reporting persistent symptoms which have lasted for at least 8-weeks after initial infection with COVID-19 and which interfere with day-to-day activity.
2. Participants should be recovering at home and have access to an Android (SDK16 or higher) or iPhone (iOS version 10 or higher) mobile phone.

Participant type
Patient

Age group
Adult

Gender
Both

Target number of participants
Planned sample size is 172 with 86 participants per group. To allow for 30% attrition, we plan to recruit a total of 125 per group and 250 participants in total.

Participant exclusion criteria
1. Currently receiving ongoing care for LC via primary or secondary care services.
2. Prior diagnosis with a comorbidity with similar symptoms (e.g. ME/CFS).
3. Currently receiving a therapy known to cause exacerbations.
4. Currently participating in another LC focussed intervention.
5. Impaired cognitive function which compromises comprehension of study information or messaging.
6. Insufficient English language for messaging to be effective.
7. No mobile phone access

Recruitment start date
01/12/2021

Recruitment end date
01/05/2022

More at https://www.isrctn.com/ISRCTN16033549

 

And an article on the trial from the University of the West of Scotland.

LONG COVID LINK TO EXTREME FATIGUE TARGETED

"Long Covid’s detrimental effect on energy and activity levels is being examined by University of the West of Scotland researchers in a bid to help improve extreme fatigue symptoms linked with the condition.

The study, which is part of a new cohort of 15 projects totalling nearly £20 million funded by the National Institute for Health Research (NIHR), will involve activity tracking to help those with Long Covid who are reporting low energy levels after undertaking day-to-day tasks.

Using a technique called adaptive pacing therapy – commonly used to treat those with Chronic Fatigue Syndrome – researchers at UWS will send ‘just-in-time’ notifications to individuals’ mobile devices when they are at risk of overexertion, in order to help alleviate symptoms and aid their long-term recovery.

The announcement comes just after the First Minister addressed Long Covid as an increasing concern, particularly amongst younger people, in her latest statement to the Scottish Parliament.

The study is the second Long Covid-related research project underway at UWS, following the announcement in February that the University would be leading a project tracking and identifying trends in persistent Long Covid symptoms."

https://www.uws.ac.uk/about-uws/uws-together/long-covid-link-to-extreme-fatigue-targeted/

 

Says everything. Little chance this produces anything useful, or that they understand the basics of what's going on.

It's not a freaking treatment anymore than avoiding smoke is a treatment for asthma. This whole paradigm of pragmatic trials is a useless mess, too many factors to take into account.

But if even minimally competent, it could, possibly could, be useful in countering GET. I'm just not holding my breath, as minimal competence has historically been way too much to ask here.

 

exclusions mean no one with serious symptom post covid will actually be in this trial so who is funding it and why is it happening .

 

I missed that announcement from February.

But I don't understand how we could be involved in the development of the study if those recruitment dates are correct:

?

Would it still be worthwhile to submit feedback?

(Edited to remove probably redundant remark.)

 

If they only meant to exclude people who had ME already before Covid and they wanted to have a sample only with Covid-triggered PEM symptoms (that after 6 months would be diagnosed as ME) that maybe could be OK?

But not sure if this is what they mean by their exclusion criteria:

Above all, I think the inclusion criteria are weird as if I understood correctly, people don't need to have PEM to participate in a study that investigates PEM?

Inclusion criteria:

So all people who don't feel fit after eight weeks past their Covid infection with all kind of ongoing symptoms are eligible (except if too cognitively impaired to use the app/ follow the instructions, which people with severe PEM might be for some time so perhaps won't apply.)

And so many other issues, e.g. it would have been nice to have objective measures as primary outcomes; the control group could be made more like a real control group if they were given activity trackers, too etc.

 

Can't they use ME as a control/comparison group? See if the two illnesses work differently?

 

I was part of this study. In a 'parallel' group.

This week I received the app. 25% join the dots tests, 75% questions on your health and how you perceive it.

I think it's outrageous. Black and white, all the old questions, catch alls, leading questions, even asking about shopping bags.

Even the join the dots is a waste of time. Why can't they acknowledge the fact that if I did the test 30 times in a month he would be a huge difference in my results.

At worst this is a complete waste of money. Pity the Long Coviders in Scotland.