Anemia, Sickle CellNCT05087303
Telemedicine for Children With Sickle Cell Disease
A study testing Types of Telemedicine Delivery Models in people with Anemia, Sickle Cell, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- Types of Telemedicine Delivery Models
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2022to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- If a patient receives chronic transfusion therapy, they will not be eligible to participate, as our telemedicine models will not support this.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedicine for Pediatric Sickle Cell Patients in Medically Underserved Areas
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
- Being tested
- Types of Telemedicine Delivery Models
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Types of Telemedicine Delivery ModelsOther
Each arm delivers standard sickle cell care using a different model based on patient location.
| Study group | Role | What they receive |
|---|---|---|
| Hub and Spoke | Active comparator | Not described Receives: Other: Types of Telemedicine Delivery Models |
| Direct to Consumer | Active comparator | Not described Receives: Other: Types of Telemedicine Delivery Models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring adherence to appointment in sickle cell care.
Failed appointments in Electronic Medical Record - no more than one failed appointment during pilot year.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year
Caregiver feedback
Telemedicine satisfaction survey (TESS) - administered to caregivers following each telemedicine visit. 0-5 Likert scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start23 Nov 2022
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Seethal Jacob, MD, MS, Indiana University
- Investigators
- Seethal Jacob, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087303
- Sponsor's protocol ID
- 2101344406
- Other IDs
- 1K23HL143162-01A1
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Pediatric Sickle Cell Patients in Medically Underserved Areas
- ClinicalTrials.gov ID
- NCT05087303
- Acronym / sponsor ID
- 2101344406
- Conditions
- Anemia, Sickle Cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hub and Spoke | Active comparator | Other: Types of Telemedicine Delivery Models |
| Direct to Consumer | Active comparator | Other: Types of Telemedicine Delivery Models |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- If a patient receives chronic transfusion therapy, they will not be eligible to participate, as our telemedicine models will not support this.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Types of Telemedicine Delivery ModelsEach arm delivers standard sickle cell care using a different model based on patient location. | Other | Direct to Consumer, Hub and Spoke |
Primary outcome
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.
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.
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.
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.
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
Caregiver feedback
Time frame: 1 year
Telemedicine satisfaction survey (TESS) - administered to caregivers following each telemedicine visit. 0-5 Likert scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seethal Jacob, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Types of Telemedicine Delivery Models in people with Anemia, Sickle Cell, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring adherence to appointment in sickle cell care. (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.