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CompletedNCT05087303Updated Jun 16, 2026

Telemedicine for Children With Sickle Cell Disease

An interventional study of Types of Telemedicine Delivery Models in Anemia, Sickle Cell, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Indiana University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Anemia, Sickle Cell

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03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's enrollment of 24 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Hub and Spoke

    Other: Types of Telemedicine Delivery Models

  • Active comparator
    Direct to Consumer

    Other: Types of Telemedicine Delivery Models

Interventions

  • OtherTypes of Telemedicine Delivery Models

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

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What researchers measure

Primary outcomes

  1. Measuring adherence to appointment in sickle cell care.

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

    Time frame: 1 year

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

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

    Time frame: 6 months

  3. 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.

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

  5. Provider Feedback

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

    Time frame: 1 year

  6. Caregiver feedback

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

    Time frame: 1 year

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Study locations

1 site
  • Indiana University
    Indianapolis, Indiana 46202, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05087303
Lead sponsor
Indiana University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Seethal Jacob, MD, MS (Assistant Professor of Pediatrics, Indiana University) — Principal investigator
First posted
Oct 21, 2021
Start date
Nov 23, 2022
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026
Last update
Jun 16, 2026

Study contacts

Seethal Jacob, MD
principal investigator · Indiana University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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