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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of telemedicine as a treatment for sickle cell anemia?

Research shows that telemedicine can improve access to care for sickle cell patients, especially in rural areas, by increasing the number of medical encounters without needing more staff. This suggests telemedicine can help manage sickle cell disease effectively by making it easier for patients to receive regular care. ^{1 2 3 4 5}

Is telemedicine safe for use in humans?

Telemedicine has been shown to be safe and satisfactory for patients with sickle cell disease and those undergoing hematopoietic cell transplantation, with high patient satisfaction and usability reported in studies. ^{1 2 4 6 7}

How does telemedicine treatment for sickle cell anemia differ from other treatments?

Telemedicine for sickle cell anemia is unique because it allows patients to access healthcare remotely, which can be especially beneficial for those in rural or underserved areas who face barriers to in-person care. This approach provides regular follow-up and acute care evaluations without the need for travel, making it more convenient and accessible compared to traditional in-person visits. ^{1 2 4 8 9}

Research Team

Seethal Jacob, MD

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

References

1. Switzerland 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A feasibility study of telemedicine for paediatric sickle cell patients living in a rural medically underserved area. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Sickle cell disease telemedicine network for rural outreach. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Telemedicine in sickle cell disease: Patient, parent, and provider perspectives. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Co-Management Model for Myeloid Malignancies That Evolved during the COVID-19 Pandemic. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Accessible Care with High Patient Satisfaction: Telemedicine Use in Sickle Cell Disease. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pilot Study of Telehealth Evaluations in Patients Undergoing Hematopoietic Cell Transplantation. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Expanding a Regional Sickle Cell Disease Project ECHO® to Rapidly Disseminate COVID-19 Education. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Understanding caregiver burden with accessing sickle cell care in the Midwest and their perspective on telemedicine. [2023]