Information from the
Trial registry
Study type: screening
Current interventions
All data will be collected via REDCap, which is an online secure and safe platform. Participants will complete online forms to provide the following:
1. Consent to the study
2. Personal details such as gender and ethnicity
3. Symptom data, including fatigue severity
4. Quality of life data
5. Pain data
6. Well-being data
Previous interventions:
Data collection:
Data collection using REDCap: The Paediatric service uses online systems to collect assessment and outcome data online in CYP. The research team at the service have developed, tested and use online consent to enable participants to take part in trials. Therefore, all participants will use REDCap to record their answers. Only members of the research team will have access to the participant’s data recorded in REDCap.
Demographic Data: we will collect the following demographic data: date of birth, gender, ethnicity, NHS number.
Symptom data: We will collect the following data at assessment (yes=frequently present): cognitive problems, headaches, muscle aches, joint aches, sore throats, tender lymph nodes, nausea, dizziness, palpitations, respiratory problems.
Patient Reported Outcome Measures (PROMs): We will collect the following Patient Reported Outcomes Measures which are routinely collected at assessment in the ME/CFS clinics: Fatigue (Chalder fatigue scale, 11 items; Physical Function (SF-36 physical function subscale); pain (visual analogue scale); Anxiety and Depression (Adults: Hospital Anxiety and Depression Scale, Children and young people: Revised Childrens Anxiety and Depression Scale).
At Royal United Hospital Bath, demographic data and the PROMs are collected using REDCap and we will therefore obtain consent to use this data, rather than ask the CYP to complete these questionnaires again. We will therefore only collect symptom data on REDCap for CYP. At North Bristol Trust, participants will be asked to provide all the data using REDCap.
Sample collection: Saliva samples will be collected from all consenting participants. They will be labelled with barcode ID numbers and personal information will not be passed to researchers/technicians processing or analysing the samples. Participants can choose to collect saliva at home or in clinic. If participants chose to collect saliva at home, we would send them an Oragene Saliva collection kits with a returned address envelope, sample pot and instructions.
The instructions include a link to a video describing how to collect the saliva. Previous feasibility work has demonstrated that adults with ME/CFS have found these easy to use at home and have produced saliva from which good quality DNA can be extracted. If participants prefer, samples can be collected in the specialist ME/CFS service with help from the research nurse (or the recruiting clinician). All samples will be posted to the Bristol Bioresource Laboratories (BBL), Oakfield House, University of Bristol. If there is indication of Pompe disease and/or LGMD2A, these participants will undergo further testing to confirm the diagnosis of Pompe disease/LGMD2A. This is likely to include providing a second saliva sample for testing or a blood sample for DBS testing in a certified NHS clinical setting.
Intervention type
Other
Primary outcome measure
1. Symptoms are measured via a 4-point Likert scale from 1 (all of the time) to 4 (none of the time) at baseline.
2. Fatigue is measured by the Chalder Fatigue Questionnaire which is 11 items. Participants answer these items on a 4-point Likert scale from 1 (less than usual) to 4 (much more than usual) at baseline.
3. Pain is measured using a visual analogue scale (VAS) at baseline.
4. Anxiety and depression for adults is measured by the Hospital Anxiety and Depression Scale which is 14 items. Participants answer these items on a 4-point Likert scale at baseline.
5. Anxiety and depression for children and young people is measured by the Revised Children’s Anxiety and Depression Scale which is 47 items. Participants answer these items on a 4-point Likert scale from 1 (never) to 4 (always) at baseline.
