Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App

NCT04675645 | Completed

• 1 other identifier: IRB 2015-761
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This project addresses three important research questions. First, adolescents and young adults (AYA) with sickle cell disease (SCD) and their parents/caregivers will be engaged to inform the (1) domains of health-related quality of life (HRQOL) most important to them, (2) frequency at which they are willing to complete them, and (3) other procedures related to the use, uptake and effect of the HU-Go app as a tool to improve hydroxyurea (HU) adherence. Second, this study seeks to utilize novel modern mobile technology using a multi-functional personalized platform to improve adherence to HU and measure HRQOL in youth with SCD, using NIH-endorsed PROMIS® measures, based on a conceptual model with predefined behavioral targets and mediators. Third, we plan to assess HRQOL changes and identify modifiable behavioral strategies that could serve as surrogates or predictors for HU adherence. This real-time feedback might empower self-directed changes in behavior that could improve adherence to HU.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Achieving feasibility based on the number of participants completed all study procedures within 6 months of study enrollment

  Feasibility is defined as having 80% or more of study participants complete the study within 6 months of enrollment

  3 months of study enrollment

Secondary Outcomes (4)

• Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items

  3 months of study enrollment

• Adherence to Hydroxyurea using Visual Analogue Scale

  3 months of study enrollment

• Patient satisfaction with the smartphone app intervention (HU-Go)

  3 months of study enrollment

• HRQOL outcomes

  3 months

Study Arms (1)

HU-Go app intervention arm

OTHER

Participants will use HU-Go app intervention arm for a total of 12 weeks.

Other: HU-Go app

Interventions

HU-Go app OTHER

A novel multifunctional mobile app (HU-Go) to improve adherence to hydroxyurea in patients with sickle cell disease

HU-Go app intervention arm

Eligibility Criteria

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

You may qualify if:

• At least 12 years old at the time of study enrollment
• Diagnosis of sickle cell disease (hemoglobin SS or SC or S/B 0 thalassemia) confirmed by hemoglobin electrophoresis
• On hydroxyurea
• Own or have access to a smartphone
• Be able to speak and read English

You may not qualify if:

• Chronic monthly transfusion support
• Any hemoglobinopathy other than sickle cell disease

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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• 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: August 17, 2016
• First Posted: December 19, 2020
• Study Start: May 15, 2018
• Primary Completion: July 11, 2020
• Study Completion: July 11, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)