Clinical trial NCT04698876: Self Tonometry and Transfer of Glaucoma Patients' Data for Improving the Supply Situation
Official title: SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Intraocular Pressure
Patient Empowerment
Telemedicine
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Federal Joint Committee
name: Bielefeld University
name: Fraunhofer Institute for Applied Information Technology FIT
name: KVWL
name: BARMER
name: DAK Gesundheit
name: IKK
name: AOK PLUS
First posted: 2021-01-07
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Number of observed pressure peaks (>30% of the patient-specific target pressure)
timeFrame: 7 days (outpatient) or minimum 24 hours (stationary)
Secondary outcomes:
measure: Quality of life (patient-oriented)
timeFrame: Baseline and after 12 months
measure: Visual field index (VFI)
timeFrame: Baseline and after 9 and 12 months
measure: Mean deviation (MD)
timeFrame: Baseline and after 9 and 12 months
measure: Pattern standard deviation (PSD)
timeFrame: Baseline and after 9 and 12 months
measure: Retinal nerve fiber layer thickness
timeFrame: Baseline and after 12 months
measure: Rim volume
timeFrame: Baseline and after 12 months
measure: Rim area
timeFrame: Baseline and after 12 months
measure: Systolic and diastolic blood pressure
timeFrame: for 24 hours during outpatient and stationary measurements of intraocular pressure
measure: Number of inpatient and outpatient health services
timeFrame: 12 month course
measure: Costs of health services
timeFrame: 12 month course
measure: Number of periods of incapacity for work (unspecific and diagnosis-specific)
timeFrame: 12 month course
measure: Number of sick pay days
timeFrame: 12 month course
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital Dortmund
city: Hagen
country: Germany
facility: Kath. Krankenhaus Hagen, St.-Josefs-Hospital
city: Lüdenscheid
country: Germany
facility: Klinikum Luedenscheid
city: Münster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster
name: Nicole Eter, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oldiges K, Steinmann M, Duevel JA, Gruhn S, Diener R, Leclaire MD, Al-Nawaiseh S, Eter N; SALUS study group. SALUS-a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up. Graefes Arch Clin Exp Ophthalmol. 2022 Dec;260(12):3945-3955. doi: 10.1007/s00417-022-05759-7. Epub 2022 Jul 22.