Table 1 Primary and secondary outcomes, measures and timepoints
Outcomes | Measures | Timepoints (months) |
|---|---|---|
Primary | ||
 EDS | ESS (adults) [28] ESS-CHAD [32] (adolescents) | 0, 3, 6, 9, 12 incident patients 0, 6, 12 prevalent patients |
Secondary | ||
 Other symptoms | Cataplexy diary, NSS [33], BDI [34], STAI [35] (adults) CDI2 [36], MASC [37] (adolescents) Global Impression Scale [38] (physicians) | 0, 3, 6, 9, 12 incident patients 0, 6, 12 prevalent patients |
 Compliance to treatment | Clinical consultation | 0, 3, 6, 9, 12 incident patients 0, 6, 12 prevalent patients |
 Weight | Standard weight scale provided to each patient | 0, 3, 6, 9, 12 incident patients 0, 6, 12 prevalent patients |
 Lipidic/glycaemic control* | Laboratory tests | 0, 12 |
 Caloric intake | Food diary | 0, 12 [0, 3, 6, 9, 12 patients with metabolic problems] |
 Physical activity | Short-IPAQ [29] | 0, 12 [0, 3, 6, 9, 12 patients with metabolic problems] |
 Satisfaction index | CoTenar (patients and caregiver)** | 6, 12 |
 Quality of life | SF-36 (adults) [39] PedsQL [40] (adolescents) | 0, 6, 12 |
 Number (%) of full dropouts |  | At the time of censorship |
 Number (%) of partial dropouts (patients changing procedure) |  | At the time of arm change |
 Adverse drug reactions | Clinical consultation | 0, 3, 6, 9, 12 incident patients 0, 6, 12 prevalent patients |
 Costs and accidents | Interview (patients and caregivers) | 0, 6, 12 |
 Other feasibility indexes | Failure system report (physicians and patients) | After each TV |