Telemedicine for Children With Sickle Cell Disease

NCT05087303 | Active Not Recruiting

• 2 other identifiers: 21013444061K23HL143162-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about how the use of two different types of telemedicine (distance medical care) can address barriers to receiving comprehensive sickle cell care, and whether care can be improved. Aim 1: Adapt two telemedicine models (i.e., hub-and-spoke; direct-to-consumer) for use with children with SCD using caregiver input from our preliminary K12 work. Aim 2: Demonstrate the feasibility of the telemedicine models developed in Aim 1 as the models undergo successive stakeholder refinement during use in actual clinical care. Aim 3: Evaluate the effectiveness of the refined models from Aim 2 in a pre/post study by assessing (a) process of care measures, (b) provider satisfaction, (c) caregiver/patient-centered outcomes, and (d) clinical outcomes and healthcare utilization.

Conditions

Anemia, Sickle Cell

Outcome Measures

Primary Outcomes (6)

• Measuring adherence to appointment in sickle cell care.

  Failed appointments in Electronic Medical Record - no more than one failed appointment during pilot year.

  1 year

• Measuring adherence to lab draws in sickle cell care.

  Adherence to lab draws - a minimum of one complete blood count per six months.

  6 months

• Measuring healthcare utilization pre and post telemedicine participation.

  Will determine the frequency of 1) vasoocclusive pain episode; 2) acute chest syndrome; 3) Emergency department visits; 4) hospitalizations. This data will be collected through chart abstraction from Electronic Medical Record one year prior to study entry and one year on study.

  1 year

• Measuring collaboration of primary care provider and subspecialty care provider.

  Documentation of Primary Care Provider communication of visits in the electronic medical record at least 70% of the time.

  1 year

• Provider Feedback

  Telemedicine Acceptance Questionnaire (TAQ) - will be given to all providers participating in telemedicine visits after every telemedicine visit. 0-5 Likert scale

  1 year

• Caregiver feedback

  Telemedicine satisfaction survey (TESS) - administered to caregivers following each telemedicine visit. 0-5 Likert scale

  1 year

Study Arms (2)

Hub and Spoke

ACTIVE COMPARATOR

Other: Types of Telemedicine Delivery Models

Direct to Consumer

ACTIVE COMPARATOR

Other: Types of Telemedicine Delivery Models

Interventions

Types of Telemedicine Delivery Models OTHER

Each arm delivers standard sickle cell care using a different model based on patient location.

Direct to Consumer; Hub and Spoke

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregivers must be 18 years or older, who have children between 0 to 21 years old with a diagnosis of Sickle Cell Disease and receive care at the Riley Hospital for Children Comprehensive Sickle Cell Disease clinic.
• Adolescent patients 16 years and older are also able to participate in interviews/surveys.
• The family must be willing to receive their care using the telemedicine model available to them based on the location of their primary residence.
• TeleSCD model participants must live within 1 hour of the pre-identified telemedicine sites, while VirtualSCD model participants must live within the city limits of the pre-identified area.

You may not qualify if:

• If a patient receives chronic transfusion therapy, they will not be eligible to participate, as our telemedicine models will not support this.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

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

• Seethal Jacob, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• 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 15, 2021
• First Posted: October 21, 2021
• Study Start: November 23, 2022
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)