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

Primary Purpose

Chronic Fatigue Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ASARM
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring CFS/ME, Chronic fatigue syndrome, Pediatric, remote mobile technology

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central Manchester University Hospitals NHS Foundation Trust Harrington Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Mid treatment Group

Start of Treatment Group

Audit group

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Change from Baseline Pain score at post intervention.
A pain visual analogue pain scale. A reduction in pain score indicates improvement

Full Information

First Posted
March 4, 2014
Last Updated
November 30, 2018
Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT02082730
Brief Title
The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population
Acronym
ASARM
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 1, 2014 (Actual)
Study Completion Date
August 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Manchester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
CFS/ME, Chronic fatigue syndrome, Pediatric, remote mobile technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mid treatment Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Start of Treatment Group
Arm Type
Experimental
Arm Description
Newly presented patients, will collect activity data using the ASARM system.
Arm Title
Audit group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ASARM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Pediatric Quality of Life Inventory (PedsQL) score at post intervention.
Description
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.
Time Frame
Baseline and post intervention
Title
Change from Baseline in Revised Child Anxiety and Depression Scale (RCADS) at post intervention.
Description
Measure of anxiety and depression. A reduction in score indicates an improvement.
Time Frame
Baseline and Post intervention
Title
Change from Baseline Activity level at post intervention.
Description
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.
Time Frame
Baseline, post intervention,
Secondary Outcome Measure Information:
Title
Change from Baseline Pain score at post intervention.
Description
A pain visual analogue pain scale. A reduction in pain score indicates improvement
Time Frame
Baseline and post intervention
Other Pre-specified Outcome Measures:
Title
ASARM Outcome
Description
Outcome measure to asses patient's experience of using the ASARM system.
Time Frame
Post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci,
Organizational Affiliation
Central Manchester Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Manchester University Hospitals NHS Foundation Trust Harrington Building
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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