Remote Access: Cortical Visual Impairment

NCT ID: NCT03957980

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2018-11-13

Brief 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

Cortical Visual Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telehealth Intervention First

The participants in this arm of the study received occupational therapy via telehealth in the first 12 weeks of enrollment, then received no other intervention for the duration of the study.

Group Type: OTHER

Occupational therapy

Intervention Type: OTHER

Child/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.

No Intervention First

The participants in this arm of the study did not receive an intervention in the first 12 weeks of enrollment, but received occupational therapy via telehealth during the second 12 weeks of enrollment.

Group Type: OTHER

Occupational therapy

Intervention Type: OTHER

Child/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.

Interventions

Occupational therapy

Child/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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children aged 12 months to 6 years 11 months with suspected or previously diagnosed Cortical Visual Impairment If the child has previously diagnosed Cortical Visual Impairment, they receive regular ongoing therapy related to vision, no more than one time/session a week at the time of recruitment.
• Caregivers of the children with suspected/ diagnosed Cortical Visual Impairment need to be cognitively able to provide meaningful consent and parent permission in order to be included in the study
• Home address must be in either Ohio, Kentucky, West Virginia or Indiana (due to Occupational Therapy licensure laws and telehealth).
• English speaking

Exclusion Criteria

• Children who were not referred for an evaluation for Cortical Visual Impairment
• Children who don't live in Ohio, Kentucky, Indiana, or West Virginia
• Children who are already receiving more than one therapy sessions related to vision a week

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 83 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2017-0356

Identifier Type: -

Identifier Source: org_study_id