Telemedicine for Sickle Cell Anemia

Overseen By Seethal Jacob, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Chronic transfusion therapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how telemedicine (remote medical care) can improve treatment for children with sickle cell disease. Researchers are testing two telemedicine models: one that connects directly with families and another that involves local healthcare centers. The goal is to simplify access to necessary care and determine if these models enhance health outcomes and satisfaction. Families with children diagnosed with sickle cell disease, who are open to using telemedicine and live near specific areas, might be suitable for this trial. As an unphased study, this trial offers families the chance to contribute to innovative care solutions that could enhance treatment accessibility and satisfaction.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic transfusion therapy, you cannot participate in this trial.

What prior data suggests that these telemedicine models are safe for children with sickle cell anemia?

Research has shown that telemedicine can safely manage sickle cell disease (SCD). Studies have found that patients and caregivers generally favor both the "Direct to Consumer" and "Hub and Spoke" telemedicine models. In the "Direct to Consumer" model, patients and healthcare providers rated telemedicine highly for usefulness and satisfaction, noting its ease of use and reliability.

In the "Hub and Spoke" model, a healthcare provider at a central location (hub) connects with patients at various locations (spokes). Early results suggest this model can improve access to care without compromising safety. However, concerns remain, such as maintaining patient data privacy and the absence of traditional in-person exams.

Overall, while telemedicine carries some risks, both models have proven to be well-accepted and helpful in managing sickle cell disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different telemedicine models for treating sickle cell anemia because these methods can potentially make healthcare more accessible and convenient for patients. The "Direct to Consumer" model allows patients to receive care directly through their personal devices, eliminating the need for frequent in-person visits and reducing travel burdens. The "Hub and Spoke" model connects patients to specialized care through a central hub, offering coordinated and comprehensive management of their condition. These approaches could lead to faster, more efficient care and improve overall quality of life for individuals with sickle cell anemia.

What evidence suggests that these telemedicine models are effective for sickle cell anemia?

Research has shown that telemedicine can effectively help manage sickle cell anemia (SCD). In this trial, participants will experience different telemedicine delivery models. The direct-to-consumer model, one study arm, simplifies access to care for people with SCD, enabling regular check-ins with doctors without travel, which benefits those far from specialized centers. Another study arm, the hub-and-spoke model, enhances care by connecting specialized health centers with local clinics. Both models aim to reduce caregiver burden and facilitate access to necessary care for families. Early findings suggest these methods can improve health outcomes and increase satisfaction for both patients and healthcare providers. ^{1 2 5 6 7}

Who Is on the Research Team?

Seethal Jacob, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for caregivers over 18 with children (0-21 years) diagnosed with Sickle Cell Disease at Riley Hospital's clinic. Adolescents aged 16+ can also join. Participants must be willing to use telemedicine based on where they live, with specific distance criteria for different models.

Inclusion Criteria

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

My family and I agree to use telemedicine for our care based on where we live.

I am a caregiver, 18 or older, with a child (0-21) who has Sickle Cell Disease and is treated at Riley Hospital.

Exclusion Criteria

I am not on chronic transfusion therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation and Feasibility

Adaptation of telemedicine models and demonstration of feasibility with stakeholder refinement

6 months

Regular telemedicine visits

Evaluation

Evaluation of the effectiveness of telemedicine models in a pre/post study

1 year

Telemedicine visits and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Types of Telemedicine Delivery Models

Trial Overview The study tests two telemedicine models: hub-and-spoke and direct-to-consumer, adapted for children with SCD. It aims to refine these models through stakeholder feedback and evaluate their effectiveness in improving care processes, satisfaction, patient outcomes, and healthcare usage.

How Is the Trial Designed?

Group I: Direct to Consumer Active Control 1 Intervention

Group II: Hub and Spoke Active Control 1 Intervention

Types of Telemedicine Delivery Models is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Telemedicine for:

• Sickle Cell Disease Management
• Chronic Pain Management
• Routine Follow-Up Care

Approved in European Union as Telehealth for:

• Sickle Cell Disease Care
• Pain Management
• Health Monitoring

Approved in Canada as Virtual Care for:

• Sickle Cell Disease Management
• Chronic Pain Management
• Health Education

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The establishment of telemedicine clinics for sickle cell disease in rural Georgia significantly increased patient encounters from 1413 to 1889 per year, demonstrating improved access to care for over 1000 patients.

During the 36-month study, 128 patients participated in 77 telemedicine clinics, resulting in a notable rise in rural outreach from 271 to 745 encounters, all achieved with minimal changes in staffing, highlighting the efficiency of telemedicine in managing sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sickle cell disease telemedicine network for rural outreach. Woods, KF., Johnson, JA., Kutlar, A., et al.[2017]

Telemedicine was successfully implemented for pediatric sickle cell disease (SCD) care, with 90% of participants maintaining a 100% follow-up rate after starting telehealth visits, indicating high engagement and feasibility in a rural area.

All patients who participated in telemedicine visits were started or maintained on hydroxyurea treatment, demonstrating that telehealth can effectively support essential medication management for SCD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of telemedicine for paediatric sickle cell patients living in a rural medically underserved area. Jacob, SA., Carroll, AE., Bennett, WE.[2022]

A survey of 99 adult patients with sickle cell disease revealed high satisfaction (median TSQ score of 56 out of 70) and above-average usability (median SUS score of 72.5 out of 100) for telemedicine visits, indicating that this approach is well-received by patients.

Participants preferred video visits for regular care (median rating of 7 out of 10) but were less favorable towards it for managing acute pain (median rating of 4), suggesting that while telemedicine is effective for routine consultations, in-person visits may still be necessary for urgent care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accessible Care with High Patient Satisfaction: Telemedicine Use in Sickle Cell Disease. Zhang, S., Xue, W., Boorman, EP., et al.[2023]

Adults with sickle cell disease (SCD) found telemedicine to be beneficial for routine follow-up care, appreciating its convenience and safety during the COVID-19 pandemic, as indicated by interviews with 30 participants.

However, patients expressed that telemedicine was less effective for managing painful crises or urgent needs, highlighting the importance of personalized care decisions that consider individual pain management preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The Patient Should Have a Choice": Adults with Sickle Cell Disease Advise Integration of Telemedicine into the Comprehensive Sickle Cell Disease Care Model. Pecker, LH., Ruvalcaba, E., Lanzkron, S., et al.[2023]

Telehealth is a feasible and acceptable method for providing follow-up care to patients undergoing hematopoietic cell transplantation (HCT), with 81% of patients reporting satisfaction with the sessions.

While 13% of providers faced challenges in completing physical examinations during telehealth visits, they were still able to manage patients' symptoms effectively, indicating that telehealth can be a viable alternative to in-person visits despite some technological limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of Telehealth Evaluations in Patients Undergoing Hematopoietic Cell Transplantation. Nawas, MT., Landau, HJ., Sauter, CS., et al.[2021]

The COVID-19 and Sickle Cell Disease Project ECHO® telementoring program successfully expanded its curriculum to address urgent educational needs during the pandemic, resulting in a 170% increase in average attendance, with 20 sessions held over nearly two years.

A significant majority (91%) of participants reported improved knowledge about COVID-19 management in the context of sickle cell disease, highlighting the program's effectiveness in enhancing healthcare providers' understanding during a public health crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding a Regional Sickle Cell Disease Project ECHO® to Rapidly Disseminate COVID-19 Education. Shook, LM., Farrell, CB., Mosley, C.[2022]

A survey of 52 patients/caregivers and 10 healthcare providers showed high satisfaction with telemedicine for sickle cell disease, indicating it is a useful and effective model of care during the COVID pandemic.

Satisfaction scores for telemedicine visits were comparable to in-person visits, suggesting that telemedicine can effectively overcome barriers to accessing healthcare for patients with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine in sickle cell disease: Patient, parent, and provider perspectives. Speller-Brown, B., Carhuas, C., Stone, A., et al.[2023]

A survey of 101 caregivers of children with sickle cell disease revealed that nearly 20% traveled over an hour to access specialized care, highlighting significant barriers related to distance and resources.

Most caregivers expressed a willingness to use telemedicine for SCD care, indicating it could be a valuable tool to improve access, although they noted that some aspects of telemedicine would need to be adapted for better effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding caregiver burden with accessing sickle cell care in the Midwest and their perspective on telemedicine. Jacob, SA., Bouck, J., Daas, R., et al.[2023]

A telehealth-based co-management model for elderly patients with myeloid malignancies allows them to receive specialized care from an academic center while continuing treatment close to home, addressing the challenges of travel and access.

In a cohort of 12 patients with a median age of 81, the model resulted in a median treatment duration of 357 days and a low hospitalization rate, indicating that this approach is both effective and safe for managing complex conditions in frail populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Co-Management Model for Myeloid Malignancies That Evolved during the COVID-19 Pandemic. Goradia, N., Shastri, A., Verma, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11538030/

Tracking Telehealth Needs for Individuals With Sickle Cell ... We aimed to evaluate telehealth experiences and satisfaction for routine visits among adults and caregivers of children with SCD within a US regional ...

2. liebertpub.com liebertpub.com/doi/abs/10.1089/tmj.2023.0422

Assessing Patterns of Telehealth Use Among People with ... It may increase access to care among people with sickle cell disease (SCD). This study examined (1) telehealth use, (2) characteristics of telehealth use, and ( ...

3. withpower.com withpower.com/trial/phase-anemia-sickle-cell-10-2021-ec442

Telemedicine for Sickle Cell Anemia Trial Overview The study tests two telemedicine models: hub-and-spoke and direct-to-consumer, adapted for children with SCD. It aims to refine these models ...

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09383-x

Understanding caregiver burden with accessing sickle cell ... This cross-sectional study describes barriers to care experienced by caregivers of children with SCD, regardless of proximity to an SCD center.

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/159318

Assessing Patterns of Telehealth Use Among People with ... Assessing patterns of telehealth use among people with sickle cell disease enrolled in Medicaid during the start of the COVID-19 pandemic.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11257828/

Assessing Patterns of Telehealth Use Among People with ... Telehealth can be defined as using remote technologies to provide health care. It may increase access to care among people with sickle cell disease (SCD).

7. researchgate.net researchgate.net/publication/366291855_Telemedicine_in_sickle_cell_disease_Patient_parent_and_provider_perspectives

Telemedicine in sickle cell disease: Patient, parent, and ... HCP rated Usefulness, Ease of use, Effectiveness, Satisfaction as “good,” and Reliability as “excellent.” Press Ganey scores for satisfaction ...