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

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.

Conditions

• Chronic Fatigue Syndrome

Interventions

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.

Sponsors & Collaborators

• University of Manchester

  collaborator OTHER

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Paul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci, · Central Manchester Foundation Trust

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2014-08-01

Completion

2014-08-01

Countries

• United Kingdom

Study Locations