Clinical trial NCT07015034: Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice
Official title: Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice (DETECT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vision Impairment and Blindness
Glaucoma
Age-Related Macular Degeneration
Cataract
Diabetic Retinopathy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 460
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: In this cohort study, the investigators will test vision screenings in Danish general practice for patients over 70 years of age with minimum one chronic condition. The main outcome is detection of vision impairment and secondary outcome is detection of conditions needing ophthalmologic follow-up but not presenting vision impairment at present time.

Detailed description: Introduction: The number of people living with visual impairment is increasing. Visual impairment causes loss in quality of life and reduce self-care abilities. The burden of disease is heavy for people experiencing visual impairment and their relatives. The severity and progression of age-related eye diseases are dependent on the time of detection and treatment options, making timely access to healthcare critical in reducing visual impairment. General practice plays a key role in public health by managing preventive healthcare, diagnostics and treatment of chronic conditions. General practitioners (GPs) coordinate services from other healthcare professionals. More involvement of the primary sector could potentially be valuable in detecting visual impairment.

Methods: Investigators apply the Medical Research Council framework for complex interventions to develop a primary care intervention with the GP as a key actor, aimed at identifying and coordinating care for patients with low vision. The development process will engage patients, relatives and relevant health professional stakeholders. The investigators will pilot test the feasibility of the intervention in a real-world general practice setting. The intervention model will be developed through a participatory approach using qualitative and creative methods such as graphical facilitation. The project aims to explore the potentials and limitations of general practice in relation to detection of preventable vision loss.

Ethics and dissemination: Ethics approval is obtained from local authority and the study meets the requirements from the Declaration of Helsinki. Dissemination is undertaken through research papers and to the broader public through podcasts and patient organisations.

Eligibility criteria: Inclusion Criteria:

* +70 years
* One or more chronic diseases
* Are followed by GP du to chronic disease

Exclusion Criteria:

* Dementia diagnosis
* Known eye-diseases or are currently followed by private ophtalmologist
* Not able to understand Danish

Primary outcomes:
measure: vision below 0,7 habitual vision on the best seeing eye
timeFrame: From enrollment in GP setting and diagnostic tests to ophtalmologist review two weeks hereafter
Secondary outcomes:
measure: detection of eye-diseases
timeFrame: From enrollment in GP setting and diagnostic tests to ophtalmologist review two weeks hereafter
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Louise Uhre General Practice
city: Køge
country: Denmark
facility: Søndre Lægehus (GP practice)
Study officials:
affiliation: Center for Almen Medicin, KU
name: Frans B Waldorff
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandholdt CT, Jonsson ABR, Reventlow S, Bach-Holm D, Line K, Kolko M, Jacobsen MH, Mathiesen OH, Waldorff FB. DETECT: DEveloping and testing a model to identify preventive vision loss among older paTients in gEneral praCTice - protocol for a complex intervention in Denmark. BMJ Open. 2023 May 29;13(5):e069974. doi: 10.1136/bmjopen-2022-069974.