Glaucoma, Intraocular Pressure, Patient Empowerment, Telemedicine
Conditions
Brief summary
The SALUS project is developing a new form of care, the application of self-tonometry by the patient itself, and an accompanying electronic case file connecting clinics, doctor's offices and patients.
Detailed description
The SALUS project is developing an outpatient, intersectoral form of care in which patients measure their intraocular pressure in their home environment with a so-called self-tonometer. The measured intraocular pressure values are incorporated into daily pressure profiles, which can be viewed via an electronic case file together with further examination data both by the treating ophthalmologists in the doctor's offices and clinics and by the patients. The new form of care not only supports the telemedical networking of doctors but also increases the compliance by involving the patient in the entire course of the illness.
Interventions
PROCEDURESelf-tonometry by means of ICareHOME
Outpatient measurement of intraocular pressure at home
PROCEDUREIntraocular measurement by means of rebound tonometry or Goldmann applanation tonometry
Stationary measurement of intraocular pressure in a clinic
PROCEDUREBlood pressure
Blood pressure measurement for 24 h
Sponsors
Federal Joint Committee
Bielefeld University
Fraunhofer Institute for Applied Information Technology FIT
KVWL
BARMER
DAK Gesundheit
IKK
AOK PLUS
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requirement of a stationary day and night measurement * Statutory health insurance * Verified and suspicion of glaucoma diagnosis with suspicion of pressure variations and peaks or not attained target pressure or suspicion of glaucoma progression (H40.1, H40.2 und H42.-) * Willingness for therapy in one of the participating clinics * Adequate German language skills * Signed and dated informed consent for study participation and data transfer * Legal capacity of the insurant to agree to the study participation
Exclusion criteria
* Patients outside the catchment area of the participating clinics * Covering illnesses in psychiatry, neurology or other indications (e.g. impairment of independence) which make self-tonometry impossible * Strong communication barriers that do not allow the instruction to carry out the intervention * Unclear legal capacity of the potential study participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of observed pressure peaks (>30% of the patient-specific target pressure) | 7 days (outpatient) or minimum 24 hours (stationary) | Measurement of intraocular pressure by means of ICareHOME, rebound tonometry or Goldmann applanation tonometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual field index (VFI) | Baseline and after 9 and 12 months | By means of perimetry |
| Mean deviation (MD) | Baseline and after 9 and 12 months | By means of perimetry |
| Pattern standard deviation (PSD) | Baseline and after 9 and 12 months | By means of perimetry |
| Retinal nerve fiber layer thickness | Baseline and after 12 months | By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT) |
| Rim volume | Baseline and after 12 months | By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT) |
| Quality of life (patient-oriented) | Baseline and after 12 months | By means of a questionnaire, 0: very bad state of health, 1: best possible state of health |
| Systolic and diastolic blood pressure | for 24 hours during outpatient and stationary measurements of intraocular pressure | Long-term blood pressure measurement |
| Number of inpatient and outpatient health services | 12 month course | Care provider/ statutory health insurance (SHI) routine data |
| Costs of health services | 12 month course | Care provider/ SHI routine data |
| Number of periods of incapacity for work (unspecific and diagnosis-specific) | 12 month course | Interview/ SHI routine data |
| Number of sick pay days | 12 month course | Interview/ SHI routine data |
| Rim area | Baseline and after 12 months | By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT) |
Countries
Germany
Outcome results
None listed