The health impairment under investigation is deafblindness (DB) or hearing and visual impairment (HVI). This is a highly complex, dual sensory impairment that goes beyond the sum of the two individual impairments. The core problem lies in the inability to compensate for the loss of one sense with the other. This leads to severe limitations in spatial and personal orientation, as well as to significant barriers to communication. Consequently, this often results in social isolation, sensory depriv
Conditions
Interventions
Group 1: Study protocol for the intervention group (IG)
- Allocation: Participants are allocated to the intervention group using a stratified block randomisation procedure. Stratification is based on
Sponsors
Deutsches Taubblindenwerk GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General eligibility criteria: - Diagnosis: All individuals of any age with suspected or confirmed deafblindness (DB) or a hearing and visual impairment (HVI). - Communication: Participation is not dependent on whether conventional forms of communication are used. - Consent: A signed informed consent form must be provided. Specific requirements depending on the group: - Affected individuals (for questionnaires and interviews): -- Sufficient knowledge of German. -- In the case of individuals who are unable to participate independently, their legal representatives must be involved. - Legal representatives: -- Must hold a valid enduring power of attorney for healthcare matters. - Staff and partners (for qualitative interviews): Staff from the DVSP site teams, the central project team and cooperation partners must have sufficient knowledge of German.
Exclusion criteria
Exclusion criteria: General exclusion: - Individuals or their legal representatives who do not provide a signed consent form. Exclusion from the patient-centred evaluation only (due to acute illness): Individuals for whom allocation to the control group (resulting in a six-month delay in intervention) would be ethically or medically irresponsible. Examples include: - Sudden hearing and/or vision loss requiring urgent medical attention. - Infants up to 6 months of age with abnormal hearing findings (following newborn screening) and suspected visual impairment (as immediate intervention is necessary for optimal development). - Planned ENT or ophthalmological surgery during the data collection period. Note: Exclusion from the summative evaluation does not automatically mean exclusion from the entire project; these patients may still receive the intervention and be included in the process evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is health-related quality of life. This is operationalized using the Pediatric Quality of Life Inventory (PedsQL), which is available in both self-report and parent-report versions for all relevant age groups. The analysis focuses on the generic core set of 23 items, covering physical, emotional, social, and school-related (or cognitive) functioning. | — |
Secondary
| Measure | Time frame |
|---|---|
| To enable a multidimensional assessment of the intervention’s effectiveness, the following secondary endpoints will be measured: - Social participation: The degree of participation in social life will be assessed using an adapted version of the Index of Participation in Social Life (IMET). - Communication experience: The subjective experience of communication and interaction (including tactile communication) is assessed using an adapted version of the questionnaire ‘Identification of Children, Young People and Adults with Deafblindness/Hearing and Visual Impairment’ (IKI-Tau). | — |
Countries
Germany
Contacts
Public ContactManuela Glattacker
Sektion Versorgungsforschung und Rehabilitationsforschung (SEVERA)
Outcome results
None listed