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

August 31, 2022 updated by: Ildar Fakhradiyev, Asfendiyarov Kazakh National Medical University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

458

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 050012
        • Kazakh Scientific - Research Institute of Eye Diseases
      • Astana, Kazakhstan, 010000
        • Medical Centre Hospital of President'S Affairs Administration of the Republic of Kazakhstan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with diagnosed age-related macular degeneration

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • NEI-VFQ-25

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the recruitment to the study
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.
at the recruitment to the study
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.
at the recruitment to the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asfendiyarov Kazakh National Medical University

Investigators

  • Principal Investigator: Inara Isamyilova, PhD, Asfendiyarov Kazakh National Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Actual)

July 27, 2022

Study Completion (Actual)

July 27, 2022

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 18, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

According to the patient consent form data is not available for scientific use by others than the project group members.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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