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:
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