Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients

Overview

The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: July 27, 2022

Detailed Description

Background and study aims. Age-related macular degeneration (AMD) is the most prevalent chronic progressive ocular disease. It has been showed in several studies that AMD affects the quality of life of patients. The aim of this study is to evaluate the quality of life of AMD patients related to vision using the short version of the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25), patients' social support, and their relationship with demographic and clinical variables. Who can participate? Patients with AMD, who wish to participate, will be recruited. Patients will be recruited from three locations of the Kazakh Scientific – Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent. What does the study involve? The study involves collecting demographic data of the participants, collecting baseline visual testing data from medical records, filling out of the NEI-VFQ-25, and answering two yes/no questions related to the social support and reliability of social support. What are possible benefits and risks of participating? Assessment of quality of life and social support of the AMD patients is a first step of developing targeted psycho-social support programs for AMD patients. Where is the study run from? Patients will be recruited from three locations of the Kazakh Scientific – Research Institute of Eye Diseases in Almaty, Nur-Sultan and Shymkent. When is the study starting and how long it is expected to run for? Start date 03/02/2020. End date 27/08/2022. Who is funding the study? No funding for this study. Who is the main contact? Principal investigator: Inara Ismailova; +380 73 200 0688; i.ismayilova@gmail.com

Interventions

  • Other: National Eye Institute Visual Function Questionnaire
    • National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) measures the quality of life related to vision. This questionnaire has been validated for use on low vision patients.

Arms, Groups and Cohorts

  • Patients with age-related macular degeneration
    • Patients with age-related macular degeneration who fill out the quality of life questionnaire, and answer questions about social support and reliability of social support

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life of AMD patients
    • Time Frame: at the recruitment to the study
    • Vision related Quality of life (QOL) of AMD patients related to vision assessed by NEI-VFQ-25 total score at the recruitment. NEI-VFQ-25 has 28 questions with multiple choice answers, each rated 0,25, 50, 75 or 100. The overall score is measured as a mean of all answers

Secondary Measures

  • Social Support
    • Time Frame: at the recruitment to the study
    • Percentage of AMD patients with Social Support. Social Support of AMD patients at the recruitment assessed by answering a yes/no question.
  • Reliability of Social Support
    • Time Frame: at the recruitment to the study
    • Percentage of AMD patients with a reliable Social Support. Reliability of Social Support of AMD patients at the recruitment assessed by answering a yes/no question.
  • Relationship between QOL and social support
    • Time Frame: at the recruitment to the study
    • Correlation between the overall quality of life of AMD patients and demographic, visual characteristics, and social support tested with multiple linear regression model. The Hosmer-Lemeshow goodness-of-fit test will be used to test the model’s fit. All tests will be two-tailed with a significance level of 0.05.

Participating in This Clinical Trial

Inclusion Criteria

  • age-related macular degeneration; ability to speak and understand Russian and/or Kazakh language; willingness to participate Exclusion Criteria:

  • Presence of glaucoma, cataracts of grade 2 or more according to the Lens Opacities Classification System (LOCS) III, and the presence of corneal opacities or any other retinal diseases

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asfendiyarov Kazakh National Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ildar Fakhradiyev, PhD – Asfendiyarov Kazakh National Medical University
  • Overall Official(s)
    • Inara Isamyilova, PhD, Principal Investigator, Asfendiyarov Kazakh National Medical University
  • Overall Contact(s)
    • Inara Ismayilova, PhD, +380 73 200 0688, i.ismayilova@gmail.com

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