Advancing Feasibility and Acceptability of Digital Cognitive Rehabilitation in Sickle Cell Disease

NCT06770010 | Recruiting

• 1 other identifier: STUDY00000906
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site nonrandomized pilot clinical trial of the feasibility, acceptability, and efficacy of a combination treatment involving digital Cogmed working memory skills training, social support components, and memory strategy training to improve adherence to Cogmed in youth with sickle cell disease ages 7-16 years.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (3)

• Number of participants who complete Cogmed training

  At least 75% of participants will complete 10 or more Cogmed training sessions.

  Approximately 5-8 weeks after start of Cogmed training

• Number of participants who attend a Cogmed Kickoff social event

  At least 75% of participants will attend a Cogmed Kickoff social event.

  Within approximately 6 months of study enrollment

• Number of participants who participate in memory strategy training

  At least 75% of participants will complete 2 or more memory strategy training sessions.

  Approximately 5-8 weeks after start of Cogmed training

Secondary Outcomes (1)

• Number of Cogmed training sessions completed

  Approximately 5-8 weeks after start of Cogmed training

Study Arms (1)

Cogmed+

EXPERIMENTAL

Home-based digital cognitive rehabilitation and memory strategy training targeting working memory functioning.

Behavioral: Cogmed+

Interventions

Cogmed+ BEHAVIORAL

Cogmed is a home-based, digital working memory training program compatible with tablet devices. The program, designed for children ages 7 and older, consists of engaging cognitive exercises that target skills involving visuospatial and verbal working memory. An essential component of Cogmed training involves assignment of an intervention "coach" who has access to detailed data on the user's training data. Families will have videoconference meetings once per week with an intervention coach to review progress, provide feedback and answer any questions that arise during treatment. In addition, participants' coaching calls will be supplemented with direct instruction on the use of memory strategies. Social support interventions will also be provided involving three primary approaches: (1) multi-family Cogmed Kickoff social events; (2) social incentives; and (3) peer navigator support.

Cogmed+

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of sickle cell disease (any genotype).
• Between ages 7-16 years old.
• Patients will only enter the treatment phase if they score \>1 SD below the normative mean on at least one standardized working memory assessment (i.e., Digit Span or Spatial Span subtests) or demonstrate a relative weakness in working memory (\>1 SD below the estimated IQ).

You may not qualify if:

• Motor, visual, or auditory impairment that prevents computer use.
• Diagnosis of a mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.
• History of photosensitive seizures.
• Insufficient English fluency.
• Recent initiation or dose adjustment of a stimulant medication to treat attention problems (\< 30 days).

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

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

• Steven Hardy, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Hardy, PhD

CONTACT

202-476-5000; sjhardy@childrensnational.org

Sara Ropeta, BS

CONTACT

202-476-5000; sropeta@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 13, 2025
• Study Start: March 5, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)