R49.0
Conditions
Interventions
Group 1: Group A: Care as usual, 10 therapy sessions with a speech and language therapist in a 1:1 setting
Group 2: Group B1: 5 therapy sessions 1:1 with a speech and language therapist, every second
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Language requirements for informed participation, answering questions, and undergoing therapy • Medically diagnosed functional dysphonia • Initial prescription for voice therapy (ST2) • VHI-30 was administered
Exclusion criteria
Exclusion criteria: • No functional voice disorder (e.g., organic cause) • Desire for therapy to transition the voice in trans patients • Already undergoing voice therapy treatment • Therapy for professional singers' voices • Non-consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for assessing the non-inferiority of the various SIP programs compared to standard therapy is the improvement in functional, physical, and emotional aspects of the voice disorder as measured by the Voice Handicap Index (VHI-30) before inclusion in the study and up to 12 weeks after the t0 measurement (t1). The VHI-30 is a questionnaire that assesses functional, physical, and emotional aspects of a voice disorder, each of which is subjectively rated by the patient on a five-point scale and added up to a total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Beyond the primary proof of efficacy, the following secondary questions regarding the efficacy of the different self-learning programmes should be answered: - Do voice parameters in groups B1, B2 and C improve by at least the same amount as in group A (the standard therapy group) from t0 to t1? - Are the medium-term effects on voice parameters (t2, eight months after diagnosis at t0) in groups B1, B2 and C at least as good as in group A? - Are there differences in effectiveness between the different therapy settings? - Are certain patient groups particularly suited to one form of therapy? - Which factors (including gender, age and living conditions) are conducive to or detrimental to the success of the therapy? PROCESS EVALUATION: The following questions will be answered based on a combination of the results of the process and effectiveness evaluations: - Does the preference expressed with regard to the design of the self-learning programme influence the voting results and frequency of participation? - How does satisfaction with the respective self-learning programme influence effectiveness outcomes? ACCOMPANYING RESEARCH In preparation for the start of recruitment, focus groups with consensus procedures based on the Delphi method are to be initiated before the start of the study with a group of prescribers (ENT doctors and phoniatrists) to establish uniform criteria for an ST2 prescription. In addition to the planned process evaluation with the recruited patients in the RCT, interviews with treating speech therapists will be conducted for each study arm to answer the following question: - How well can group and individual therapy be implemented in combination with EL from the therapists' perspective? | — |
Countries
Germany
Contacts
Public ContactSimone Miller
Medizinische Hochschule Hannover
Outcome results
None listed