Telemedicine for Sickle Cell Anemia
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Disqualifiers: Chronic transfusion therapy
No Placebo Group
Approved in 3 Jurisdictions
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.
12345Is 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.
12467How 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.
12489Eligibility 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.
+1 more
Exclusion Criteria
I am not on chronic transfusion therapy.
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Group I: Direct to ConsumerActive Control1 Intervention
Group II: Hub and SpokeActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana UniversityIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
"The Patient Should Have a Choice": Adults with Sickle Cell Disease Advise Integration of Telemedicine into the Comprehensive Sickle Cell Disease Care Model. [2023]Adults with sickle cell disease (SCD) constitute a unique and vulnerable patient population with complex healthcare needs including routine follow-up visits and acute care evaluations. The COVID-19 pandemic accelerated healthcare systems' transition to providing telemedicine care. The purpose of this qualitative study was to elicit the perspectives of adults with SCD about their experience with telemedicine during the COVID-19 pandemic and to understand their preferences with respect to future telemedicine care.
A feasibility study of telemedicine for paediatric sickle cell patients living in a rural medically underserved area. [2022]Sickle cell disease (SCD) is the most common inherited haematological disease, with potentially devastating complications. Improvements in therapies have increased the life span of patients with SCD, but this is contingent on receiving timely evidence-based medical care, including regular evaluations with haematologists, disease-specific education and psychosocial care. Our objective was to evaluate the feasibility of utilizing telemedicine for the provision of subspecialty paediatric SCD care in a rural medically underserved area.
Sickle cell disease telemedicine network for rural outreach. [2017]The Medical College of Georgia (MCG) Sickle Cell Center in Augusta, Georgia, USA, provides consultation and (in some cases) primary-care services to more than 1000 patients with sickle cell disease (SCD). Three SCD telemedicine clinic sites were established in rural areas of middle and southern Georgia, based on clinical need; a fourth site had been proposed. Over a 36-month study period, 77 telemedicine SCD clinics were held. There was a mean of 6.1 (SD 2.5) encounters per clinic and 466 total encounters among 128 SCD patients. By using telemedicine, the productivity of the MCG adult sickle cell clinic increased from 1413 to 1889 encounters a year, with an increase in rural outreach activity from 271 to 745 encounters a year. This was accomplished with the addition of a single physician assistant during the last 12 months of the study period; otherwise provider staffing was unchanged. A formal cost-benefit analysis now needs to be carried out.
Telemedicine in sickle cell disease: Patient, parent, and provider perspectives. [2023]Patients with sickle cell disease (SCD) need frequent health maintenance visits and may face barriers accessing care. Telemedicine, during COVID pandemic, has provided a unique model of care to improve access; however, potential barriers and satisfaction with its use in SCD have not been fully evaluated.
A Co-Management Model for Myeloid Malignancies That Evolved during the COVID-19 Pandemic. [2023]Myeloid malignancies are a heterogeneous group of clonal bone marrow disorders that are complex to manage in the community and therefore often referred to subspecialists at tertiary oncology referral centers. Many patients do not live in close proximity to tertiary referral centers and are unable to commute long distances due to age, comorbidities, and frailty. Interventions that minimize the travel time burden without compromising quality of care are an area of unmet need. We describe a cancer care delivery model for patients with myeloid malignancies that is built around telehealth and enables this vulnerable population access to care at an NCI-designated cancer center while receiving majority of their care close to home.
Accessible Care with High Patient Satisfaction: Telemedicine Use in Sickle Cell Disease. [2023]Background: The COVID-19 pandemic necessitated a rapid transition to telemedicine, providing a critical opportunity to study telemedicine satisfaction and usability in patients with sickle cell disease (SCD). Methods: A cross-sectional survey was completed by 99 adult SCD patients who participated in at least one telemedicine visit between March and July 2020. Telemedicine satisfaction and usability were assessed with the Telemedicine Satisfaction Questionnaire (TSQ) and System Usability Scale (SUS), respectively. Preference for video visits was assessed with a 1-10 rating scale, with 10 indicating the highest preference. Measures of anxiety, depression, and patient activation were also assessed. Linear and logistic regressions were performed to evaluate for socioeconomic and psychosocial correlates of telemedicine satisfaction, usability, and preference. Results: Participants were 72% women, with a mean age of 39 years. The median (interquartile range [IQR]) TSQ was 56 (52-64) out of 70, indicating high satisfaction. The median (IQR) SUS was 72.5 (62.5-82.5) out of 100, indicating above average usability. Participants tended to prefer video visits for regular care (median [IQR] rating of 7 [5-9]) but not for management of acute pain (median [IQR] rating of 4 [2-8]). Neither satisfaction nor usability was associated with age or mental health. Telemedicine usability was positively associated with having private insurance compared with public insurance. Higher scores on both satisfaction and usability were associated with higher patient activation. Conclusions: Adults with SCD report good usability and high satisfaction with telemedicine, across multiple demographic groups. Therefore, telemedicine has valuable potential to improve access to high-quality care for these patients.
Pilot Study of Telehealth Evaluations in Patients Undergoing Hematopoietic Cell Transplantation. [2021]Telehealth involves the use of telecommunication and information technology for the delivery of clinical care and may be a mechanism to alleviate the burden of visits faced by patients undergoing hematopoietic cell transplantation (HCT). Few studies have evaluated the feasibility and acceptability of telehealth visits in the care of HCT patients. We conducted 27 telehealth visits with 25 patients undergoing HCT using a videoconferencing system that allows for real-time, 2-way interactions and administered satisfaction surveys to patients and providers. Of the 25 patients included in the study, 20 (80%) and 5 (20%) were undergoing autologous and allogeneic HCT, respectively. The telehealth visits were distributed as follows: 3 inpatient visits upon admission for HCT; 11 inpatient visits between 2 and 14 days post-HCT; 4 inpatient visits prior to discharge after HCT; 8 outpatient, post-HCT follow-up visits; and 1 handoff to a community oncologist. Out of a total of 54 provider assessments, 7 providers (13%) were unable to complete some part of the physical examination, but no provider reported being unable to manage patients' symptoms through telehealth. Eighty-one percent of patients were either satisfied or very satisfied with the telemedicine session. Overall satisfaction was higher among patients than providers (mean scores 4.12 versus 2.64; scale 1 to 5, with 1 = very poor to 5 = excellent). Technological barriers resulting in delays and suboptimal physical examination were largely responsible for provider dissatisfaction. The use of telehealth to deliver comprehensive follow-up care to HCT patients is feasible across different HCT types but is dependent upon quality of data streaming and videoconferencing technologies.
Expanding a Regional Sickle Cell Disease Project ECHO® to Rapidly Disseminate COVID-19 Education. [2022]Healthcare providers faced numerous knowledge gaps and challenges with adapting practice behaviors in light of the COVID-19 pandemic. In response, an established virtual sickle cell disease (SCD) telementoring program rapidly expanded from monthly evidence-based didactic sessions focused on medical and psychosocial complications of sickle cell disease, to additional supplemental COVID-19 sessions with emerging pandemic topics and forums for shared experiences to address this timely educational need among multidisciplinary healthcare providers.
Understanding caregiver burden with accessing sickle cell care in the Midwest and their perspective on telemedicine. [2023]Survival for children with sickle cell disease (SCD) has improved significantly. However, patients with SCD still encounter several impediments to accessing adequate healthcare. Rural and medically underserved areas, such as parts of the Midwest, can exacerbate these barriers, separating children with SCD from subspecialists even further. Telemedicine has been a means to close these gaps in care for children with other special healthcare needs, but few studies have discussed how caregivers of children with SCD perceive its use.