Chronic Fatigue SyndromeASARMNCT02082730
The Feasibility, Acceptability and Clinical Utility of a New Remote-mobile Technology Intervention (ASARM) for CFS/ME in a Paediatric Population
A study testing ASARM in people with Chronic Fatigue Syndrome, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- ASARM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to 1 Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 12-17
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust Harrington Building
Manchester, M13 9WL
About this study
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
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.
Read the 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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- ASARM
- Keywords
- CFS/ME, Chronic fatigue syndrome, Pediatric, remote mobile technology
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASARMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ASARM |
| Start of Treatment Group | Experimental | Newly presented patients, will collect activity data using the ASARM system. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, post intervention,
Secondary outcomes (1)
Change from Baseline Pain score at post intervention.
A pain visual analogue pain scale. A reduction in pain score indicates improvement
Measured: Baseline and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJan 2013
- Primary completion1 Aug 2014
- Study completion1 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Paul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci,, Principal investigator, Central Manchester Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082730
- Sponsor's protocol ID
- ASARM001
- Acronym
- ASARM
- Status last verified
- Nov 2018
- First submitted
- 4 Mar 2014
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02082730
- Acronym / sponsor ID
- ASARM / ASARM001
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- CFS/ME, Chronic fatigue syndrome, Pediatric, remote mobile technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester
- Study start
- Jan 2013
- Primary completion
- 1 Aug 2014 (actual)
- Study completion
- 1 Aug 2014 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mid treatment Group | Active comparator | Device: ASARMPatients 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. |
| Start of Treatment Group | Experimental | Device: ASARMNewly presented patients, will collect activity data using the ASARM system. |
| 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients aged 12-17
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASARMThe 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. | Device | Mid treatment Group, Start of Treatment Group |
Primary outcome
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.
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.
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.
1 secondary outcome
Change from Baseline Pain score at post intervention.
Time frame: Baseline and post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Abeles, Ph.D, D.Clin.Psy, Dip.Cog.Sci, principal investigator
Central Manchester Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASARM in people with Chronic Fatigue Syndrome, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pediatric Quality of Life Inventory (PedsQL) score at post intervention. (time frame: Baseline and post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.