Andy
Senior Member (Voting rights)
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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.
Further registration details
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.
Further registration details