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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427994
• Other study ID #: 1394
• Status: Completed
• Start date: April 5, 2021
• Est. completion date: July 27, 2022

Study information

• Verified date: August 2022
• Source: Asfendiyarov Kazakh National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Background and study aims. Age-related macular degeneration (AMD) is the most prevalent chronic progressive ocular disease. It has been shown 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Kazakhstan	Kazakh Scientific - Research Institute of Eye Diseases	Almaty
Kazakhstan	Medical Centre Hospital of President'S Affairs Administration of the Republic of Kazakhstan	Astana

Sponsors (1)

Lead Sponsor	Collaborator
Asfendiyarov Kazakh National Medical University

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life of AMD patients	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 38 questions with multiple choice answers, each rated 0,25, 50, 75 or 100. The overall score is measured as a mean of all answers	at the recruitment to the study
Secondary	Social Support	Percentage of AMD patients with Social Support. Social Support of AMD patients at the recruitment assessed by answering a yes/no question.	at the recruitment to the study
Secondary	Reliability of Social Support	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.	at the recruitment to the study
Secondary	Relationship between QOL and social support	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.	at the recruitment to the study