Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study

NCT04678037 | Completed

• 1 other identifier: IRB 2017-757
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this proposal is to identify modifiable behavioral strategies based on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) that will improve hydroxyurea (HU) adherence among adolescents and young adults with sickle cell disease (SCD). In this proposed study, we intend to test the functionality of a PROs-toolbox feature, which will be integrated into our existing smartphone application platform (SCD-app), over a 24-week period in a cohort of SCD patients and their caregivers.

Conditions

Sickle Cell Disease; Sickle Cell Hemoglobin C; Sickle Beta Zero Thalassemia; Sickle B+ Thalassemia

Outcome Measures

Primary Outcomes (1)

• Feasibility of completing PRO assessments at home using SCD-app (HU-Go)

  Having an overall completion rate of ≥ 50% for all study participants (Group A and B). This will be reported as a dichotomous outcome, either yes or no. The percentage (%) completion rate will be calculated as the number of PROs assessments completed divided by the number of PROs assessments expected over the study period.

  6 months

Secondary Outcomes (1)

• Completion rate of PRO assessments at home using SCD-app (HU-Go)

  6 months

Study Arms (2)

Group A (PROs assessment every 2 weeks)

ACTIVE COMPARATOR

Behavioral: PROs assessment using sickle cell disease mobile app (SCD-app)

Group A (PROs assessment every 4 weeks)

ACTIVE COMPARATOR

Behavioral: PROs assessment using sickle cell disease mobile app (SCD-app)

Interventions

PROs assessment using sickle cell disease mobile app (SCD-app) BEHAVIORAL

A smartphone app platform designed for patients with sickle cell disease. The SCD-app is programmed to send notification to patients to complete PROs assessment. The SCD-app is able to collect PROs data as patients complete the assessment using the app platform.

Group A (PROs assessment every 2 weeks); Group A (PROs assessment every 4 weeks)

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12 years or older at the time of study enrollment;
• SCD diagnosis (all genotypes) confirmed by hemoglobin electrophoresis;
• Own or have access to a smartphone or a tablet; and
• Speak and read English.

You may not qualify if:

• Patients or caregivers with cognitive impairment;
• Patients or caregivers physical impairment; and
• Patients or caregivers who will not be able to complete study assessments.

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Hemoglobin SC Disease

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sherif M Badawy, MD, MS

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 21, 2020
• Study Start: April 4, 2017
• Primary Completion: July 21, 2019
• Study Completion: July 21, 2019
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)