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

NCT02082730 | Completed

• 1 other identifier: ASARM001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CFS/ME, Chronic fatigue syndrome, Pediatric, remote mobile technology

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Pediatric Quality of Life Inventory (PedsQL) score at post intervention.

  measure of fatigue and quality of life, separately rated by child and parent (Varni, J.W., \& Limbers,C.A. (2009). An increase in score would indicate improvement in Quality of life and fatigue.

  Baseline and post intervention

• Change from Baseline in Revised Child Anxiety and Depression Scale (RCADS) at post intervention.

  Measure of anxiety and depression. A reduction in score indicates an improvement.

  Baseline and Post intervention

• Change from Baseline Activity level at post intervention.

  The average and standard variation in number of hours of clinically defined sleep, rest and activity per day for each patient will be measured through the ASARM system.

  Baseline, post intervention,

Secondary Outcomes (1)

• Change from Baseline Pain score at post intervention.

  Baseline and post intervention

Other Outcomes (1)

• ASARM Outcome

  Post intervention

Study Arms (3)

Mid treatment Group

ACTIVE COMPARATOR

Patients who have completed 6 sessions at the Manchester CFS/ME Service for Children \& Young People will be recruited. They would have had previous experience of using paper diaries.They will collect activity data using the ASARM system.

Device: ASARM

Start of Treatment Group

EXPERIMENTAL

Newly presented patients, will collect activity data using the ASARM system.

Device: ASARM

Audit group

NO INTERVENTION

To provide comparative baseline data for general treatment response, we will audit pre-treatment and post-treatment clinical data on the regular "gold standard" clinical measures package, as these are the outcome measures routinely used in the clinic.

Interventions

ASARM DEVICE

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 Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 12-17

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (1)

Central Manchester University Hospitals NHS Foundation Trust Harrington Building

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci,

  Central Manchester Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 10, 2014
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

GB (1)