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Completed

NCT Number: NCT05087303

Telemedicine for Children With Sickle Cell Disease

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Types of Telemedicine Delivery Models

Other

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

Primary outcomes

  1. Measuring adherence to appointment in sickle cell care.

    Time frame: 1 year

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

  2. Measuring adherence to lab draws in sickle cell care.

    Time frame: 6 months

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

  3. Measuring healthcare utilization pre and post telemedicine participation.

    Time frame: 1 year

    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.

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

    Time frame: 1 year

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

  5. Provider Feedback

    Time frame: 1 year

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

  6. Caregiver feedback

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Telemedicine for Pediatric Sickle Cell Patients in Medically Underserved Areas

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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