The Longitudinal Relationship of HU Adherence to HRQOL, Barriers to Adherence and Habit in SCD.

NCT04691323 | Active Not Recruiting

• 2 other identifiers: IRB 2020-33661K23HL150232
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to better understand factors contributing to variations in hydroxyurea (HU) adherence behavior in adolescents and young adults (AYA) with sickle cell disease (SCD). To meet this objective, the researchers will conduct a prospective cohort study to determine the longitudinal relationship between HU adherence and health-related quality of life (HRQOL) overtime among AYA with SCD. The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.

Conditions

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

Keywords

sickle cell disease; hydroxyurea

Outcome Measures

Primary Outcomes (1)

• Hydroxyurea adherence rate

  Adherence rate is defined as number of given HU doses given, as captured by HU-Go app, divided by total number of doses expected during study period.

  12 months

Secondary Outcomes (9)

• Adherence to Hydroxyurea using PROMIS Medication Adherence Scale (PMAS)

  12 months

• Adherence to Hydroxyurea using Visual Analogue Scale

  12 months

• Pain score using Patient reported outcomes measurement information system (PROMIS) measure

  12 months

• Fatigue score using Patient reported outcomes measurement information system (PROMIS) measure

  12 months

• Physical function score using Patient reported outcomes measurement information system (PROMIS) measure

  12 months

Study Arms (1)

HU-Go app intervention arm

OTHER

Participants will use the HU-Go app intervention arm for 12 months.

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

You may qualify if:

• Age 12-21 years old
• Any sickle cell disease genotype
• On steady state of hydroxyurea for 2 months
• Own or have access to a smartphone
• Parents of patients that meet the eligibility criteria and are enrolled in the study will be included

You may not qualify if:

• Patients with recent hospitalizations within the past 7 days

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

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: December 24, 2020
• First Posted: December 31, 2020
• Study Start: March 2, 2021
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

US (1)