Multicentre study on coaching and point-of-care technologies for patients with myalgic encephalomyelitis/chronic fatigue syndrome
| ISRCTN | ISRCTN16025168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16025168 |
| EU Horizon Europe Research and Innovation Programme | GA N° 101095654 |
| Latvian Council of Science (Latvijas Zinātnes Padome) | THCS2025-404 |
| Sponsors | Université Paris-Est Créteil, University of British Columbia, Institute for Microelectronics and Microsystems, Riga Stradiņš University |
| Funders | Agence Nationale de la Recherche, Canadian Institutes of Health Research, Ministero dell'Università e della Ricerca, Latvijas Zinātnes Padome, HORIZON EUROPE Reforming and enhancing the European Research and Innovation system |
- Submission date
- 19/03/2026
- Registration date
- 27/03/2026
- Last edited
- 10/04/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Plain English summary of protocol not provided at time of registration
Contact information
Prof François-Jérôme Authier
Principal investigator
Principal investigator
IMRB Eq. Relaix, Faculty of Medicine, 8 rue du Général Sarrail
Créteil
94000
France
 ORCID ID |
0000-0002-0182-2052 |
|---|---|
| Phone | +33 1 4981 2735 |
| francois-jerome.authier@aphp.fr |
Dr Luis Nacul
Scientific
Scientific
The University of British Columbia 6200 University Blvd
Vancouver, BC
V6T 1Z4
Canada
| ORCID ID |
0000-0003-1411-8088 |
|---|---|
| Phone | +1 2368631901 |
| luis.nacul@ubc.ca |
Dr Luca Francioso
Scientific
Scientific
Via Monteroni, University Campus Bld. A/3
Lecce
73100
Italy
| ORCID ID |
0000-0002-4500-0421 |
|---|---|
| Phone | +39832422525 |
| lucanunzio.francioso@cnr.it |
Dr Modra Murovska
Public
Public
16 Dzirciema str
Riga
LV-1007
Latvia
| ORCID ID |
0000-0003-0971-1784 |
|---|---|
| Phone | +371 29218082 |
| Modra.Murovska@rsu.lv |
Diana Araja
Scientific
Scientific
Riga Stradins University, Dzirciema Street 16
Riga
LV-1007
Latvia
| ORCID ID |
0000-0002-4558-0980 |
|---|---|
| Phone | +371 29 129 874 |
| diana.araja@rsu.lv |
Dita Pole
Scientific
Scientific
Riga Stradins University, Dzirciema Street 16
Riga
LV-1007
Latvia
| Phone | +371 22 184 451 |
|---|---|
| dita.pole@rsu.lv |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Device feasibility, Health services research, Supportive care, Treatment |
| Scientific title | Multicentre study of the effectiveness of multimodal coaching interventions and the feasibility of point-of-care test device for improving the quality of life, functional capacity, and self-management in patients with myalgic encephalomyelitis/chronic fatigue syndrome |
| Study objectives | To evaluate the effectiveness and feasibility of multi-modal coaching interventions and point-of-care test (PoCT) device use in improving the quality of life, functional capacity, and self-management in patients with ME/CFS. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Improving the quality of life of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) |
| Intervention | Study Methodology and Interventions This is a multicentre, mixed-design interventional study consisting of three study arms evaluating multimodal coaching interventions and the feasibility of a point-of-care testing (PoCT) device in patients with ME/CFS. Randomisation A stratified randomisation approach will be applied in Arm 1 to ensure balanced allocation by country and relevant baseline characteristics (e.g., disease severity). Participants will be randomly assigned in a 1:1 ratio to intervention or control groups within each stratum. Arms 2 and 3 are designed as non-randomised interventional and feasibility studies, due to their exploratory and pilot nature. Arm 1: Individual Coaching Intervention (Randomised Controlled Study) Design: Stratified randomised controlled study (1:1 allocation) Sites: Latvia (LV), France (FR) Intervention groups: • Latvia (n=30): Individual health coaching for 12 weeks • France (n=30): Individual occupational coaching for 12 weeks Control groups: • Latvia (n=30): Usual care • France (n=30): Usual care Intervention description: Participants in the intervention groups will receive structured, individual coaching sessions focusing on health management (LV) or occupational functioning (FR). Sessions will be delivered weekly or bi-weekly using standardized protocols. Duration per participant: • Intervention: 12 weeks • Follow-up: 3 months post-intervention Arm 2: Group Coaching and Education (Pilot + Multicentre Implementation) Design: Non-randomised pilot followed by multicentre implementation Sites: Canada (pilot), Latvia, France Pilot phase: • Canada (n=40): Group-based coaching and education programme (15 months total duration, including development and testing phase) Implementation phase: • Latvia (n=20) and France (n=20): Group coaching and education programme Intervention description: Participants will engage in structured group sessions focusing on patient education, self-management strategies, and peer support. Duration per participant: • Intervention: 3 months • Follow-up: 3 months post-intervention Arm 3: PoCT Device Feasibility and Usability Study Design: Non-randomised feasibility study Sites: Italy (development and initial testing), Latvia Development phase: • Italy: PoCT device development and pre-clinical validation (12 months) Clinical testing phase: • Italy (n=30): PoCT testing (5 months) • Latvia (n=30): PoCT testing (5 months) Intervention description: Participants will undergo testing with a point-of-care device measuring inflammatory cytokines and lactate in peripheral blood. Results will be compared with standard laboratory methods and correlated with clinical outcomes. Duration per participant: • Active testing: up to 5 months • Follow-up: included within study assessments Overall Study Duration The total study duration across all arms is 22 months, including intervention and follow-up phases. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 31/08/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 210 |
| Key inclusion criteria | 1. Age 18-75 years 2. Diagnosis of ME/CFS according to International Consensus Criteria (ICC), or Canadian Consensus Criteria (CCC), or Institute of Medicine/National Academy of Medicine (IOM/NAM) criteria, or National Institute for Health and Care Excellence (NICE) criteria 3. Mild, moderate or severe functional impairment (e.g., ≥ 4 Bell Disability Scale ≤ 70) 4. Capacity to provide Informed Consent |
| Key exclusion criteria | 1. Primary psychiatric disorders (e.g., schizophrenia, bipolar disorder) 2. Severe comorbidities that interfere with participation 3. Current participation in another interventional trial |
| Date of first enrolment | 01/09/2026 |
| Date of final enrolment | 29/02/2028 |
Locations
Countries of recruitment
- Canada
- France
- Italy
- Latvia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
10/04/2026: Study contacts were updated.
20/03/2026: Study’s existence confirmed by the Latvian Council of Science (Latvijas Zinātnes Padome), Latvia.
