Diabetic Retinopathy Screening in General Practice

Sponsor
Aalborg University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05276778
Collaborator
(none)
300
Enrollment
1
Location
7.1
Anticipated Duration (Months)
42.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Diabetic Retinopathy is a microvascular eye complication of diabetes, which can go unnoticed until permanent vision damage has occurred - in worst-case blindness. Timely retinopathy screenings reduce the risk of sight loss since the disease can be treated if detected in time. For people with type 2 diabetes, retinopathy screenings are typically performed by specialist at private ophthalmologists' practices, and individualized screening intervals based on retinopathy level and diabetes regulation are recommended. Unfortunately, 26% of people with type 2 diabetes do not follow their screening interval, and the attendance is too low compared to the national standard of minimum 90% of patients with diabetes who ought to follow the screening program. Consequently, actions must be taken to improve screening attendance in Denmark.

The aim of this study is to investigate patients' acceptance of diabetic retinopathy screenings in general practice. Patients' acceptance is explored through a questionnaire developed for the study.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Diabetic Retinopathy Screening

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Diabetic Retinopathy Screenings in General Practice for People With Type 2 Diabetes
Actual Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

ArmIntervention/Treatment
People with type 2 diabetes

People diagnosed with type 2 diabetes age 18-70

Diagnostic Test: Diabetic Retinopathy Screening
Screenings are performed in the diabetes consultation in general practice

Outcome Measures

Primary Outcome Measures

  1. Patients' acceptance of diabetic retinopathy screenings in general practice [1 day (the questionnarie is fufilled one time after the retinopaty screening in general practice)]

    Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Diagnosed with type 2 diabetes

  • Understands Danish

  • Age between 18-70

Exclusion Criteria:
  • Blindness

  • Cannot partake in second screening

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Malene KroghAalborgDKDenmark9000

Sponsors and Collaborators

  • Aalborg University

Investigators

  • Principal Investigator: Malene Krogh, Center for General Practice at Aalborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Malene Krogh, Ph.D. student, Aalborg University
ClinicalTrials.gov Identifier:
NCT05276778
Other Study ID Numbers:
  • mKrogh
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Malene Krogh, Ph.D. student, Aalborg University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022