Clinical Trials Directory

Trials / Completed

CompletedNCT03957980

Remote Access: Cortical Visual Impairment

Remote Access to Care for Children With Cortical Visual Impairment and Their Families

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Children's Hospital Medical Center, Cincinnati · Academic / Other
Sex
All
Age
12 Months – 83 Months
Healthy volunteers
Not accepted

Summary

This study aims to compare the efficacy of an in-home telehealth-based intervention to standard care for children with cortical visual impairment and their caregivers and to assess the feasibility and acceptability of an in-home telehealth-based intervention approach for children with cortical visual impairment and their caregivers. This pilot study will utilize a randomized two group crossover design with assessment at 4 time periods. The assessments will occur at remote locations.

Detailed description

To improve access to evaluation and treatment, the investigators will be offering remote cortical visual impairment clinics to assess children for cortical visual impairment. The cortical visual impairment clinics will be organized in public spaces such as school buildings, libraries, and/or hospital clinics. Study staff will contact potential clinics, buildings, etc., about interest in hosting these remote clinics. The cortical visual impairment clinics will be staffed by at least one of the following individuals: an ophthalmologist and/or an optometrist, a technician, and an occupational therapist. All participants will attend 4 remote cortical visual impairment clinics during the study. Prior to the initial clinic visit, the participants will be randomized into either the waitlist control group or the intervention group using the list of patients scheduled for the clinic. During the initial clinic visit, each child who has been given parental consent will complete both an eye exam (either an ophthalmologist or an optometrist) and functional vision evaluation with an occupational therapist. Both the eye exam and the functional vision evaluation occurring during the clinic visit are the same as would be provided during routine clinical care. None of the examinations provided during this research study will be billed through insurance. Those who are diagnosed with cortical visual impairment will continue on with the study. The intervention group will complete the telehealth intervention sessions and the waitlist control group will continue with standard care. All participants will attend three additional cortical visual impairment Clinics: one 4 months after the initial evaluation (+/- 2 weeks), one 8 months after initial evaluation (+/- 2 weeks) and another 12 months after the initial evaluation (+/- 2 weeks). During the final three cortical visual impairment clinics, the participants will complete and updated Cortical Visual Impairment Range and Canadian Occupational Performance Measure with the occupational therapist.

Conditions

Interventions

TypeNameDescription
OTHEROccupational therapyChild/caregiver dyads in this group will participate in telehealth-based intervention sessions in their home environment. Each child/caregiver dyad will participate in up to 9 interventions sessions. All intervention sessions will last 30-60 minutes. The intervention sessions will focus on task analysis, caregiver coaching, parent education and recommendations for task and home/environmental modifications to promote the child's functional vision.

Timeline

Start date
2017-05-02
Primary completion
2018-11-13
Completion
2018-11-13
First posted
2019-05-21
Last updated
2019-05-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03957980. Inclusion in this directory is not an endorsement.