SALUS: Self Tonometry and Transfer of Glaucoma Patients' Data for Improving the Supply Situation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Outpatient measurement of intraocular pressure The intervention group measures its intraocular pressure itself in their home environment for 7 days at 6 a.m., 8 a.m., 12 a.m., 4 p.m., 8 p.m. and 12 p.m. with a self-tonometer (iCareHOME). |
Procedure: Self-tonometry by means of ICareHOME
Outpatient measurement of intraocular pressure at home
Procedure: Blood pressure
Blood pressure measurement for 24 h
|
| Active Comparator: Stationary measurements of intraocular pressure The intraocular pressure of the control group is measured by means of rebound tonometry or Goldmann applanation tonometry in a clinic for minimum 24 hours at 6 a.m., 8 a.m., 12 a.m., 4 p.m., 8 p.m. and 12 p.m. |
Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry
Stationary measurement of intraocular pressure in a clinic
Procedure: Blood pressure
Blood pressure measurement for 24 h
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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)
- Rim area [Baseline and after 12 months]
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
- 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
Eligibility Criteria
Criteria
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:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum Dortmund | Dortmund | Germany | ||
| 2 | St.-Johannes-Hospital Dortmund | Dortmund | Germany | ||
| 3 | Kath. Krankenhaus Hagen, St.-Josefs-Hospital | Hagen | Germany | ||
| 4 | Klinikum Luedenscheid | Lüdenscheid | Germany | ||
| 5 | University Hospital Muenster | Münster | Germany |
Sponsors and Collaborators
- University Hospital Muenster
- Federal Joint Committee
- Bielefeld University
- Fraunhofer Institute for Applied Information Technology FIT
- KVWL
- BARMER
- DAK
- IKK
- AOK
Investigators
- Principal Investigator: Nicole Eter, Prof. Dr., Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 01NVF18002