Abstract
Purpose :
Some loss to follow-up of participants is inevitable in clinical trials. Common reasons to discontinue participation may be related to comorbidities and/or busy schedules. We explored whether non-visual comorbidities might influence completion of clinical trial participation for visually-impaired adults.
Methods :
Completion versus drop-out of adult, visually-impaired participants was evaluated in two randomized clinical trials of vision rehabilitation conducted in 2020-22: (1) BeST-AID: 4-month trial of telerehabilitation versus in-office training for traditional magnification devices in 56 subjects aged 18-93 (mean 72 years), and (2) CARE: 6-month trial of training for visual assistive iPhone applications (apps: SuperVision+, SeeingAI, Aira) in 111 seniors aged 55-100 (mean 73 years). Both trials assessed the Telephone Interview of Cognitive Status (m-TICS; included scores of 20+ for mild cognitive impairment or normal cognition) and SF-36 for general health at baseline. For baseline depressive symptoms, the Hospital Anxiety and Depression Scale was administered in BeST-AID and the Beck Depression Inventory was used in CARE.
Results :
To-date, completion rates were 82% and 78% in the BeST-AID and CARE trials, respectively. In both clinical trials, participants with greater baseline TICS cognitive scores had significantly greater odds of completion versus drop-out (BeST-AID: OR=1.27; 95% CI: 1.07-1.52; p=0.006)(CARE: OR=1.12; 95% CI: 1.004-1.26; p=0.04). Depressive symptoms were not significantly related to completion for BeST-AID subjects (OR=1.02; 95% CI: 0.83-1.26; p=0.85), but CARE subjects with greater baseline depressive symptoms or loneliness had significantly reduced odds of completion (BDI: OR=0.91; 95% CI: 0.82-0.997; p=0.04)(UCLA loneliness scale: OR=0.70; 95% CI: 0.51-0.95; p=0.02). Accounting for randomized group assignment was not significantly related to completion versus drop-out in BeST-AID or CARE; also visual acuity, age or SF-36 scores were not significantly associated with completion of either trial (all p>0.05).
Conclusions :
Visually-impaired participants with abnormal cognition or depressive symptoms may require additional interventional strategies to help facilitate retention in clinical trials of vision rehabilitation. These findings may have implications for generalizability of vision rehabilitation trial results to clinical populations with these common comorbidities.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.