Cortical Visual Impairment Clinical Trial
Official title:
Remote Access to Care for Children With Cortical Visual Impairment and Their Families
NCT number | NCT03957980 |
Other study ID # | 2017-0356 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2017 |
Est. completion date | November 13, 2018 |
Verified date | May 2019 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | November 13, 2018 |
Est. primary completion date | November 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 83 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Caregiver and Therapist Telehealth Qualitative Data | A questionnaire will be given to both the intervention and control group. This survey asks questions regarding the quality and the quantity of information given at the initial evaluation. The survey is in a multiple choice format and the answer options range from Strongly Disagree to Strongly Agree (Strongly Agree indicates a positive response. | 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) | |
Other | Caregiver and Therapist Intervention Questionnaire | The questionnaire will gather data regarding how the therapist and caregiver felt regarding the number of sessions, the set up, the child's improvement, etc. | 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 | |
Primary | 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 | Change in Individualized, function goals as measured by the Canadian Occupational Performance Measure (COPM) | The COPM is a valid, reliable, and responsive assessment tool (28-30) that measures the caregiver's perception of the child's performance on goals that are important to the child and his/her caregiver. The COPM will help guide the treatment plan for the Cortical Visual Impairment interventions. Overall satisfaction and performance scores are generated from the COPM and each will be treated as a continuous variable for analysis. | 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). | |
Secondary | Change in Individualized, function goals as measured by the Preverbal Visual Assessment (PreVias) | The PreVias is a questionnaire to be completed by the caregiver. It has 30 questions related to one or more visual domain including visual attention, visual communication, visual-motor coordination and visual processing. | 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). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00342108 -
Cortical Visual Impairment and Visual Attentiveness
|
N/A |