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Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population

Dolphin

Senior Member
Messages
17,567
Note that I shortened the title to get it to fit

http://www.ukctg.nihr.ac.uk/trialdetails/NCT02082730


The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population


Public Title The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population
Acronym ASARM

Source of Record URL
http://clinicaltrials.gov/show/NCT02082730


Trial


Health Condition(s) or Problem

Chronic Fatigue Syndrome


Lay Summary

This study aims to improve on the delivery of treatment for people with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME).


People with CFS/ME have low energy.


This interferes with doing everyday activities and has a major impact on quality of life.


Energy management is a key aspect of treatment and involves patients building up their energy levels gradually.


Their health professional finds out how much energy the patient uses daily so they can prescribe how much activity and rest is right for the patient.


The prescription is adjusted throughout treatment.


Over time, the patient learns the best way to "spend" and "preserve" energy.


To begin treatment, patients record their activity levels on paper over a few weeks.


Records need to be accurate, but this is often difficult because of problems with memory, concentration or low energy and pain.


We have recently developed a new technology called ASARM ("Advanced Sleep Rest Activity and Rest Management") that records activity levels electronically and checks whether they match the activity prescription.


The ASARM device is worn on the patient's wrist.


It measures sleep, activity and rest, and has an electronic diary (a smartphone app) for recording daily activities.


The health professional has remote access to the information and uses the app to change the prescription.


This study will investigate if ASARM is

(i) acceptable to patients;

(ii) a good way to deliver Cognitive Behavioural therapy CBT treatment;

(iii) able to improve their symptoms.


Patients and clinicians will gain experience of ASARM for a short time, and we will analyse their data.


Our findings will help us develop ASARM so that it can be used in routine care of CFS/ME patients.

(from ClinicalTrials.gov)


Who can enter the trial


Inclusion Criteria: -


Patients aged 12-17


Exclusion Criteria:


- Patients who do not have functional English Language


Patients who have visual impairments


Patients who have complex psychosocial presentations deemed by the team that make participation in the trial inadvisable


Who cannot enter the trial


Inclusion Criteria: - Patients aged 12-17


Exclusion Criteria: - Patients who do not have functional English Language


Patients who have visual impairments


Patients who have complex psychosocial presentations deemed by the team that make participation in the trial inadvisable


What will happen


Device; ASARM; The ASARM system combines objective and subjective measurements of sleep, rest and activity patterns by using a combination of low-cost devices and technologies.


The patient wears a wrist-mounted Actigraphy device to measure their energy expenditure, and carries an electronic diary (a Smartphone app) for recording their activities and their subjective measures of mood and energy level.


These synchronise daily with a remote server, accessible by the clinician through a web interface, to allow monitoring, data analysis and feedback to the patient.;


Mid treatment Group; Start of Treatment GroupPrimary aimChange from Baseline Pediatric Quality of Life Inventory (PedsQL) score at post intervention.; Change from Baseline in Revised Child Anxiety and Depression Scale (RCADS) at post intervention.; Change from Baseline Activity level at post intervention.


Secondary Aim


Change from Baseline Pain score at post intervention.; Baseline and post intervention; No; A pain visual analogue pain scale. A reduction in pain score indicates improvement


Participant Information Sheet


Sorry, not currently available


WebsiteSorry, not currently available


Recruitment Status Recruiting


Nation England


Location

Manchester


ContactBack to top ↑


Contact for Public QueriesSarah M Khan, Bsc, Msc sarah.khan2@cmft.nhs.uk Paul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci, Principal Investigator Central Manchester Foundation TrustContact for Scientific QueriesPaul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci,; Principal Investigator Please note:


The UKCTG information is designed to inform you of existing trials. If you wish to join a specific trial, you must discuss this with your own doctor who may decide to get in touch with the contact listed.

Please note: Trial data is sourced from multiple external providers and as such UKCTG is not responsible for, and cannot guarantee, the accuracy of data, including Location information. Please contact us if you have any query regarding the quality of trial records.
 
Messages
13,774
No control group is a pain - and they seem to be working to avoid turning this into an assessment of whether CBT is genuinely helpful in increasing 'energy' or not. Not to sure what the "complex psychosocial presentations" exclusion is about - why would that make the use of this device a particular problem? I've not seen that exclusion on CBT studies before, and there is a danger that this would allow them to just select those patient that they they are most likely to improve regardless of treatment.

This sort of thing just sounds funny to me - health professionals are assumed to know rather a lot about 'energy', how to create it and manage it:

Energy management is a key aspect of treatment and involves patients building up their energy levels gradually.

Their health professional finds out how much energy the patient uses daily so they can prescribe how much activity and rest is right for the patient.
 
Messages
15,786
Not to sure what the "complex psychosocial presentations" exclusion is about - why would that make the use of this device a particular problem? I've not seen that exclusion on CBT studies before, and there is a danger that this would allow them to just select those patient that they they are most likely to improve regardless of treatment.
More symptoms = more "complex" ... so the sicker you are with ME, the crazier you must be, according to their warped rationale. Thus they're almost certainly excluding moderate and severe ME patients, and maybe mild as well. It's a fatigue study.
 
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A.B.

Senior Member
Messages
3,780
I've not seen that exclusion on CBT studies before, and there is a danger that this would allow them to just select those patient that they they are most likely to improve regardless of treatment.

That's what psych treatment studies are all about. Also no control groups. It's a scam. Why can psych studies get away with this? Homeopathy etc. can't get away with it.

But maybe I'm being too hard. At least they are using an actigraph rather than just questionnaires!

Energy management is a key aspect of treatment and involves patients building up their energy levels gradually.

Their health professional finds out how much energy the patient uses daily so they can prescribe how much activity and rest is right for the patient.

Read: we start from the assumption that there is no organic problem causing low energy levels, and that therefore, the low energy level must be a result of cognitive or behavioural factors, and that therefore, low energy levels can be treated with behavioural and cognitive interventions. In other words: patients need someone else to tell them how much they should do, because they are utterly incapable of figuring it out themselves. Does psychology merely exist to stroke the ego of psychologists?
 
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chipmunk1

Senior Member
Messages
765
Does psychology merely exist to stroke the ego of psychologists?

It exists because it came to existence one day and like in any organism self-preservation comes before anything else.