Health Literacy - Neurocognitive Screening in Pediatric SCD

NCT04917783 | Completed

• 1 other identifier: 1345169
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine feasibility and potential benefits of providing a passport card with a summary of neurocognitive feedback results to families of patients with sickle cell disease. Given recent literature suggesting the need to be conscious of health literacy in populations with low socioeconomic status, this project is intended to provide a more health-literate appropriate format of neurocognitive evaluation feedback in the context of a routine screening program offered as a standard of care in the CHW pediatric sickle cell disease clinic. The specific aims is (1) to evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to control group and (2) to evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to control group.

Conditions

Sickle Cell Disease

Keywords

Health Literacy; Neuropsychology; Hematology; academic achievement

Outcome Measures

Primary Outcomes (2)

• Caregiver Understanding

  Evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to the control group through the semi-structured interview.

  7-14 weeks post evaluation

• Caregiver Follow-through

  Evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to the control group through the semi-structured interview.

  7-14 weeks post evaluation

Study Arms (2)

Standard of Care

OTHER

Caregivers in the standard of care-arm will receive immediate verbal feedback by a psychologist on their neurocognitive testing results, recommendations, and guidance for implementing recommendations (e.g., sending a 504 Plan request to the school). This report will contain information regarding background, test results, a summary and impressions, and bullet-pointed recommendations.

Behavioral: No Passport card

Health Literacy

EXPERIMENTAL

Participants randomized to the experimental health-literacy group will be provided with a color-coded "passport" (a two-sided wallet-sized card) highlighting key findings and recommendations of their neurocognitive testing results along with the full written report. The domains listed as either satisfactory or needing help listed on the passport card will directly correspond to those listed on the full report.

Behavioral: Passport Card

Interventions

Passport Card BEHAVIORAL

After receiving neurocognitive testing, caregivers in the health-literacy group will be provided with a color-coded "passport" (a two-sided wallet-sized card) highlighting key findings and recommendations along with their written report. Then, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback passport card and evaluation report.

Health Literacy

No Passport card BEHAVIORAL

After receiving neurocognitive testing and verbal feedback from the psychologist, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback and evaluation report, but not the passport card.

Standard of Care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants will include English-speaking patients between the ages of 6 and 17 with pediatric sickle cell disease and their caregivers (46 patient-caregiver dyads).

You may not qualify if:

• Patients will be excluded from participation if they have a history of significant neurological injury or impairment negating the benefit of a neurocognitive screening

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (2)

Children's Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53266, United States

Location

Related Publications (31)

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  BACKGROUND

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MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jeffrey Karst, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This study will use a single-blinded (qualitative coder), randomized controlled trial to evaluate the efficacy of the passport card in improving caregiver understanding and follow through with testing recommendations.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 8, 2021
• Study Start: September 25, 2019
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)