Timepoint | Study period | |||||||
---|---|---|---|---|---|---|---|---|
Enrollment −T1 −30 to −1 day | Allocation T0 day 0 | Post-allocation T1 12 months | Close-out T2 20 months | |||||
T a | C b | T a | C b | T a | C b | T a | C b | |
Enrollment | ||||||||
 Eligibility screen | × | × |  |  |  |  |  |  |
 Informed consent | × | × |  |  |  |  |  |  |
 Allocation |  |  | × | × |  |  |  |  |
Intervention |  |  | × |  | × |  | × |  |
Assessments | ||||||||
 Socio-demographic data | × | × | × | × |  |  | × | × |
 Hearing outcome | ||||||||
  Pure tone audiometry |  |  | × | × |  |  | × | × |
  HHIE-S score |  |  | × | × |  |  | × | × |
  Self-reported hearing |  |  | × | × |  |  | × | × |
  IOI-HA score |  |  |  |  | × |  | × |  |
 Quality of life (primary outcome) | ||||||||
  SF-12 score |  |  | × | × |  |  | × | × |
  EQ-5D score |  |  | × | × |  |  | × | × |
 Secondary outcomes | ||||||||
  Sub-dimension of SF-12 |  |  | × | × |  |  | × | × |
  Sub-dimension of EQ-5D |  |  | × | × |  |  | × | × |
  Physical functioning (ADLs) |  |  | × | × |  |  | × | × |
  Physical functioning (IADLs) |  |  | × | × |  |  | × | × |
  Chronic diseases |  |  | × | × |  |  | × | × |
  Cognitive function (MMSE) |  |  | × | × |  |  | × | × |
  Depression (CES-D) |  |  | × | × |  |  | × | × |
  Social support (LSNS) |  |  | × | × |  |  | × | × |
  Hospitalizations |  |  | × | × |  |  | × | × |
  Falls |  |  | × | × |  |  | × | × |
  Medical costs |  |  | × | × |  |  | × | × |
  Loss of productivity |  |  | × | × |  |  | × | × |