Age-Related Macular DegenerationNCT05427994
Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients
An observational study of Age-Related Macular Degeneration, run by Asfendiyarov Kazakh National Medical University at 2 sites in Kazakhstan.
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- National Eye Institute Visual Function Questionnaire
- How many people
- 458 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 5 Apr 2021to 27 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed age-related macular degeneration
Who may be able to join
- age-related macular degeneration; ability to speak and understand Russian and/or Kazakh language; willingness to participate
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites
Kazakh Scientific - Research Institute of Eye Diseases
Almaty, 050012
Medical Centre Hospital of President'S Affairs Administration of the Republic of Kazakhstan
Astana, 010000
About this study
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.
Read the 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
- Conditions
- Age-Related Macular Degeneration
- Being tested
- National Eye Institute Visual Function Questionnaire
- Keywords
- age-related macular degeneration, quality of life, social support, reliability of social support, vision related quality of life
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
National Eye Institute Visual Function QuestionnaireOther
Also called NEI-VFQ-25
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: National Eye Institute Visual Function Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the recruitment to the study
Secondary outcomes (3)
Social Support
Percentage of AMD patients with Social Support. Social Support of AMD patients at the recruitment assessed by answering a yes/no question.
Measured: at the recruitment to the study
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.
Measured: at the recruitment to the study
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.
Measured: at the recruitment to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start5 Apr 2021
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asfendiyarov Kazakh National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ildar Fakhradiyev, Asfendiyarov Kazakh National Medical University
- Investigators
- Inara Isamyilova, PhD, Principal investigator, Asfendiyarov Kazakh National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427994
- Sponsor's protocol ID
- 1394
- Status last verified
- Aug 2022
- First submitted
- 15 Jun 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the patient consent form data is not available for scientific use by others than the project group members.
Publications
Ismayilova I, Turdaliyeva B, Aldasheva N, Veselovskaya N. Assessing the quality of life in age-related macular degeneration patients: a cross-sectional study in Kazakhstan. Acta Biomed. 2022 Dec 16;93(6):e2022299. doi: 10.23750/abm.v93i6.13580.
PubMed 36533748
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration Patients
- ClinicalTrials.gov ID
- NCT05427994
- Acronym / sponsor ID
- 1394
- Conditions
- Age-Related Macular Degeneration
- Keywords
- age-related macular degeneration, quality of life, social support, reliability of social support, vision related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with age-related macular degeneration | – | Other: National Eye Institute Visual Function QuestionnairePatients with age-related macular degeneration who fill out the quality of life questionnaire, and answer questions about social support and reliability of social support |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed age-related macular degeneration
Key inclusion criteria (1 listed)
- age-related macular degeneration; ability to speak and understand Russian and/or Kazakh language; willingness to participate
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| National Eye Institute Visual Function QuestionnaireAlso: NEI-VFQ-25National 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 | Patients with age-related macular degeneration |
Primary outcome
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
3 secondary outcomes
Social Support
Time frame: at the recruitment to the study
Reliability of Social Support
Time frame: at the recruitment to the study
Relationship between QOL and social support
Time frame: at the recruitment to the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Derived from this study: PubMed 36533748Ismayilova I, Turdaliyeva B, Aldasheva N, Veselovskaya N. Assessing the quality of life in age-related macular degeneration patients: a cross-sectional study in Kazakhstan. Acta Biomed. 2022 Dec 16;93(6):e2022299. doi: 10.23750/abm.v93i6.13580.
- Individual participant dataSharing planned: No. According to the patient consent form data is not available for scientific use by others than the project group members.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inara Isamyilova, PhD principal investigator
Asfendiyarov Kazakh National Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by Asfendiyarov Kazakh National Medical University at 2 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of AMD patients (time frame: at the recruitment to the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.