How effective is FITNET-NHS for children and young adults with CFS/ME?

Not Applicable

Completed

• Conditions: Paediatric CFS/ME; Nervous System Diseases; Postviral fatigue syndrome

• Registration Number: ISRCTN18020851
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29471861 protocol (added 23/12/2019) 2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31856886 protocol update (added 23/12/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32784188/ pilot phase results (added 17/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-04
• Study Completion: 2022-01-12
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

1. Children aged 11 to 17 years
2. Children with CFS/ME (defined using NICE guidance)
3. Children with no local specialist CFS/ME service

Exclusion Criteria

1. Children not disabled by fatigue
2. Children whose fatigue is due to another cause
3. Children or parents unable to complete video calls (e.g. Skype) or FITNET-NHS modules (e.g. unable to read FITNET-NHS material, or significant development problems, or limited internet access, unwilling/unable to set up personal email address/video call (e.g. Skype) account)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability measured using the Physical Function Scale (SF-36-PFS) at 6 months after randomisation

Secondary Outcome Measures

Name	Time	Method
<br> Secondary outcomes are measured at 3, 6 and 12 months unless otherwise specified, and include:<br> 1. SF36-PFS measured at 3 and 12 months after randomisation<br> 2. Fatigue (Chalder scale and Checklist Individual Strength (CIS) fatigue severity subscale)<br> 3. School attendance (self-report school or home tuition)<br> 4. Mood (Revised Children’s Anxiety and Depression Scale (RCADS))<br> 5. Pain visual analogue scale<br> 6. Clinical Global Impression Scale<br> 7. Quality of Life (EQ-5D-Y)<br> 8. Parental completed: Healthcare Resource Use questionnaire<br> 9. Parental completed: Work Productivity & Activity Impairment Questionnaire General Health (WPAI:GH)<br>