The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Fatigue
Study type: Interventional

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.
    

Detailed description: 
      Standard practice is for patients to use pen and paper diaries to capture the initial
      "baseline" of sleep rest and activity. However, this can take several weeks to determine,
      relies on excellent adherence as well as the subjective recording of information that is
      sometimes hard to capture. Filling in the diaries can also place extra demands on energy and
      memory in patients and compromise treatment, particularly in the early stages of care, which
      can be characterized by feelings of hopelessness and disempowerment. Similarly, the number of
      trips to the clinic to discuss the diaries places particular demands on the energy resources
      of this patient group. ASARM's clinical impact therefore is to increase treatment adherence
      and treatment efficacy, to reduce the number of clinic visits for patients, as well as
      speeding up the processing of "diary" information for clinicians for monitoring progress and
      adapting treatment plans. ASARM will improve both the health of patients and reduce costs in
      running services by making treatments more accessible and reduce the number of appointments
      that will need to be offered.

      There are two groups of patients who will use ASARM as part of their treatment, the
      "mid-treatment group" and the "start of treatment group". Both groups will receive the
      standard CBT treatment in the clinic, however they will be provided with the ASARM equipment
      in addition to this. Data will also be collected from the clinical records of 20 patients who
      have been previously treated with the standard treatment in the Manchester CFS/ME Service for
      Children & Young People, referred to as the "case file audit" data. Finally there will be a
      focus group made up of one clinician from the service, two clinicians from other similar
      services, the researcher, and three past or present patients who have received treatment in
      the service.

      Start of treatment Group:

      Nine newly presenting patients will be assessed with the "gold-standard" fatigue outcome
      measures and then receive ASARM administered treatment for 10 weeks (in "baseline" for 2
      weeks and "prescription" mode over an 8 week period). Patients will then revert to treatment
      as usual. On completion of ASARM treatment, information on how the patient experienced the
      paper diaries versus ASARM will be explored, and their clinical measures and ASARM activity
      diary data will also be assessed

      Mid-treatment group:

      Six patients who have just completed 6 sessions at the Manchester CFS/ME Service for Children
      & Young People will be recruited. Each will be provided with ASARM treatment for 6 weeks.
      Clinicians from the CFS/ME Service will then deliver continued treatment and administer ASARM
      in "baseline" for 2 weeks and "prescription" mode over the next 4 weeks. They will then
      return to treatment as usual within the service. After completing the ASARM treatment,
      information on how the patient differentially experienced the paper diaries versus ASARM will
      be collected using the acceptability questionnaires, and their clinical outcomes will be
      assessed with the "gold-standard" fatigue outcome measures along with their rest, sleep and
      activity data from ASARM. The activity diary data and clinical data contained in these
      patient's case files before ASARM treatment will also be collected (see below for a more
      detailed overview).

      "Case file audit" data:

      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 described in the "endpoints" section, as these are the outcome measures
      routinely used in the clinic. This information will be extracted from the records of 20
      consecutive existing patients receiving treatment as usual i.e. patients who have used paper
      activity records. Their treatment duration will be dictated by the length of time a first
      post-treatment data set is available in the clinical case file, and that is closest to 10
      weeks.

      Focus groups The focus group will be formed and asked to review ASARM through description and
      demonstration. Feedback used for advising on the clinical protocol and for potential
      refinements to be made to the system in the future. When a draft version of the treatment
      manual is developed the Focus group meets to review this and suggest any changes necessary.
      When all patients have completed treatment, all clinician participants in the service who
      have had patients use ASARM form a focus group to explore their experiences and consider how
      ASARM data compares with TAU patients.
    

Intervention name(s): ASARM
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CFS/ME, Chronic fatigue syndrome, Pediatric, remote mobile technology