Clinical trial NCT03957980: Remote Access: Cortical Visual Impairment
Official title: Remote Access to Care for Children With Cortical Visual Impairment and Their Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cortical Visual Impairment
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This pilot study will utilize a randomized two group crossover design with assessment at 4 time periods.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Functional Vision as measured by the Cortical Visual Impairment Range
timeFrame: Collected at the Initial Remote Clinic and the 4-month follow up clinic for the intervention first group and the 8-month follow up clinic for the no intervention first group
Secondary outcomes:
measure: Change in Individualized, function goals as measured by the Canadian Occupational Performance Measure (COPM)
timeFrame: The COPM will be completed before the intervention, at month 4 in clinic, month 8 (via phone/ email/ mail) and month 12 in clinic (all +/- 2 weeks).
measure: Change in Individualized, function goals as measured by the Preverbal Visual Assessment (PreVias)
timeFrame: The PreVias will be completed before the intervention, at month 4 in clinic, month 8 (via phone/ email/ mail) and month 12 in clinic (all +/- 2 weeks).
Other outcomes:
measure: Caregiver and Therapist Telehealth Qualitative Data
timeFrame: Completed at the end of the Initial Remote Clinic visit (consent is obtained and an eye exam is completed here; the survey is filled out immediately following the eye exam)
measure: Caregiver and Therapist Intervention Questionnaire
timeFrame: Completed at the 4-month Follow Up Remote Clinic for the Intervention First group and completed at the 8-month Follow Up Remote Clinic for the No Intervention First group
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: