Remote Access: Cortical Visual Impairment

NCT03957980 | Completed

• 1 other identifier: 2017-0356
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cortical Visual Impairment

Outcome Measures

Primary Outcomes (1)

• Change in Functional Vision as measured by the Cortical Visual Impairment Range

  the Cortical Visual Impairment Range is a reliable assessment utilized to measure functional vision for children with Cortical Visual Impairment.. The Cortical Visual Impairment Range consists of 10 behavioral characteristics common in children with Cortical Visual Impairment. Each behavioral characteristic is rated on a scale from 0-1. The characteristic scores are summed to get an overall score of functional vision. This score will be treated as a continuous variable for analysis.

  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 (2)

• Change in Individualized, function goals as measured by the Canadian Occupational Performance Measure (COPM)

  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).

• Change in Individualized, function goals as measured by the Preverbal Visual Assessment (PreVias)

  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 (2)

• Caregiver and Therapist Telehealth Qualitative Data

  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)

• Caregiver and Therapist Intervention Questionnaire

  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

Study Arms (2)

Telehealth Intervention First

OTHER

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.

Other: Occupational therapy

No Intervention First

OTHER

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.

Other: Occupational therapy

Interventions

Occupational therapy 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; Telehealth Intervention First

Eligibility Criteria

• Age: 12 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Blindness, Cortical

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The occupational therapist at the remote clinics assessing outcomes did not know what point in time the subjects were receiving the intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study will utilize a randomized two group crossover design with assessment at 4 time periods.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 21, 2019
• Study Start: May 2, 2017
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)