Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082730
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Device: ASARM Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Initial Trial of ASARM: an Advanced Sleep and Rest Monitoring System for Treating Paediatric CFS/ME: Assessing Acceptability and Adaptation Into Current CBT Treatment Protocols
Study Start Date : January 2013
Actual Primary Completion Date : August 1, 2014
Actual Study Completion Date : August 1, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mid treatment Group
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
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.

Experimental: Start of Treatment Group
Newly presented patients, will collect activity data using the ASARM system.
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.

No Intervention: Audit group
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.



Primary Outcome Measures :
  1. Change from Baseline Pediatric Quality of Life Inventory (PedsQL) score at post intervention. [ Time Frame: Baseline and 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.

  2. Change from Baseline in Revised Child Anxiety and Depression Scale (RCADS) at post intervention. [ Time Frame: Baseline and Post intervention ]
    Measure of anxiety and depression. A reduction in score indicates an improvement.

  3. Change from Baseline Activity level at post intervention. [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Change from Baseline Pain score at post intervention. [ Time Frame: Baseline and post intervention ]
    A pain visual analogue pain scale. A reduction in pain score indicates improvement


Other Outcome Measures:
  1. ASARM Outcome [ Time Frame: Post intervention ]
    Outcome measure to asses patient's experience of using the ASARM system.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082730


Locations
Layout table for location information
United Kingdom
Central Manchester University Hospitals NHS Foundation Trust Harrington Building
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Manchester University NHS Foundation Trust
University of Manchester
Investigators
Layout table for investigator information
Principal Investigator: Paul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci, Central Manchester Foundation Trust

Layout table for additonal information
Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02082730     History of Changes
Other Study ID Numbers: ASARM001
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Keywords provided by Manchester University NHS Foundation Trust:
CFS/ME, Chronic fatigue syndrome, Pediatric, remote mobile technology
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases