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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05087303
Other study ID # 2101344406
Secondary ID 1K23HL143162-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date November 23, 2022
Est. completion date January 1, 2026

Study information

Verified date April 2024
Source Indiana University
Contact Seethal Jacob, MD
Phone 317-278-9662
Email seejacob@iu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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: - If a patient receives chronic transfusion therapy, they will not be eligible to participate, as our telemedicine models will not support this.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Types of Telemedicine Delivery Models
Each arm delivers standard sickle cell care using a different model based on patient location.

Locations

Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring adherence to appointment in sickle cell care. Failed appointments in Electronic Medical Record - no more than one failed appointment during pilot year. 1 year
Primary Measuring adherence to lab draws in sickle cell care. Adherence to lab draws - a minimum of one complete blood count per six months. 6 months
Primary 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. 1 year
Primary 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. 1 year
Primary Provider Feedback Telemedicine Acceptance Questionnaire (TAQ) - will be given to all providers participating in telemedicine visits after every telemedicine visit. 0-5 Likert scale 1 year
Primary Caregiver feedback Telemedicine satisfaction survey (TESS) - administered to caregivers following each telemedicine visit. 0-5 Likert scale 1 year
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