Impact of COVID-19 on Quality of Life of Seniors With Eye Disease and Implementations to Improve Wellness

NCT04910282 | Recruiting DMC

• 1 other identifier: 115875
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

Brief Summary

The ophthalmology clientele is vulnerable in the context of the coronavirus disease 2019 (COVID-19) pandemic because of their age and comorbidities. Specifically, elderly patients aged 65 and above with glaucoma, age-related macular degeneration, or diabetic retinopathy require regular follow-ups and commonly suffer from additional comorbidities. Further, because of the proximity between the patient and health care personnel during ophthalmological examinations, the risk of infection during visits is significant. The delicate balance between the risk of exposure to COVID-19 and visual loss in delaying cases is a psychological stressor to both patients and clinicians. A cross-sectional study accumulating the data of 425 patients aged 65 and above with various eye diseases will be conducted. Participants will be presented with a set of online questionnaires designed to collect data on health-related quality of life (HRQOL), vision-related quality of life (VRQOL), depression symptoms, anxiety, sleep quality, community integration, and their experience with tele-consultations. This study can help quantify the collateral impact of the COVID-19 beyond the direct impact of the virus, to improve future quality of care guidelines on non-COVID-19 conditions, and to help plan patient prioritization once restrictions are eased.

Conditions

Covid19; Eye Diseases

Keywords

Eye disease patients; Psychological stressors; COVID-19; Seniors

Outcome Measures

Primary Outcomes (1)

• health-related quality of life (HRQoL)

  HRQoL is an essential measure of quality of life related to health; it helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. HRQoL will be measured using time trade-off questionnaire. It is measured in a scale of 0 to 1, with higher scores indicating a better outcome. This means that 0 indicates poor HRQoL and 1 indicates perfect health.

  Immediately upon receiving the participant's consent to participate in the study

Secondary Outcomes (4)

• Visual Function Score

  Immediately upon receiving the participant's consent to participate in the study

• Depression

  Immediately upon receiving the participant's consent to participate in the study

• Anxiety

  Immediately upon receiving the participant's consent to participate in the study

• Sleep Quality

  Immediately upon receiving the participant's consent to participate in the study

Study Arms (1)

Eye Disease Patients

Patients with eye diseases age 65 and above will be included. Patients from the Ivey Eye Institute, St. Joseph's Health Care London, ON will be recruited in-person, based on inclusion and exclusion criteria.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Ivey Eye Institute, St. Joseph's Health Care London, ON will be recruited in-person based on inclusion and exclusion criteria.

You may qualify if:

• Patients diagnosed with an eye disease by an experienced ophthalmologist.
• Patients with eye diseases age 65 and above.
• Be able to provide valid informed consent to participate in the research study.
• Being able to read and understand English.
• Having no significant self-reported or a physician diagnosed mental health disorder.

You may not qualify if:

• Inability to provide a valid informed consent.
• Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
• Severe depression as confirmed by a CES-D ≥ 24.
• Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
• Self-reported substance abuse or dependence within the past 3 months.
• Having an acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
• Having irreversible vision loss that prevents one from completing the questionnaires.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A4V2, Canada

RECRUITING

Related Publications (7)

• Globe DR, Varma R, Torres M, Wu J, Klein R, Azen SP; Los Angeles Latino Eye Study Group. Self-reported comorbidities and visual function in a population-based study: the Los Angeles Latino Eye Study. Arch Ophthalmol. 2005 Jun;123(6):815-21. doi: 10.1001/archopht.123.6.815.

  PMID: 15955983 BACKGROUND

• Sabel BA, Wang J, Cardenas-Morales L, Faiq M, Heim C. Mental stress as consequence and cause of vision loss: the dawn of psychosomatic ophthalmology for preventive and personalized medicine. EPMA J. 2018 May 9;9(2):133-160. doi: 10.1007/s13167-018-0136-8. eCollection 2018 Jun.

  PMID: 29896314 BACKGROUND

• Salari N, Hosseinian-Far A, Jalali R, Vaisi-Raygani A, Rasoulpoor S, Mohammadi M, Rasoulpoor S, Khaledi-Paveh B. Prevalence of stress, anxiety, depression among the general population during the COVID-19 pandemic: a systematic review and meta-analysis. Global Health. 2020 Jul 6;16(1):57. doi: 10.1186/s12992-020-00589-w.

  PMID: 32631403 BACKGROUND

• Lam DSC, Wong RLM, Lai KHW, Ko CN, Leung HY, Lee VYW, Lau JYN, Huang SS. COVID-19: Special Precautions in Ophthalmic Practice and FAQs on Personal Protection and Mask Selection. Asia Pac J Ophthalmol (Phila). 2020 Mar-Apr;9(2):67-77. doi: 10.1097/APO.0000000000000280.

  PMID: 32349113 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Aylward, Bruce (WHO); Liang, W. (PRC). Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). 2020; vol. 2019 16-24.

  BACKGROUND

• Quillen DA. Common causes of vision loss in elderly patients. Am Fam Physician. 1999 Jul;60(1):99-108.

  PMID: 10414631 BACKGROUND

MeSH Terms

Conditions

COVID-19; Eye Diseases; Stress, Psychological

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Study Officials

• Monali Malvankar

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali M Malvankar, PhD

CONTACT

5196858500; monali.malvankar@sjhc.london.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 2, 2021
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)