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NCT04691323 Clinical Trial

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

Sickle Cell Disease Clinical Trial

Official title:
The Longitudinal Relationship of Hydroxyurea Adherence Behavior to Health-related Quality of Life, Barriers to Adherence and Habit Formation in Patients With Sickle Cell Disease.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04691323
Other study ID # IRB 2020-3366
Secondary ID 1K23HL150232
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2, 2021
Est. completion date February 2025

Study information
Verified date September 2023
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Sickle cell disease is the most common genetic disorder in the US, affecting about 100,000 Americans, and about 1 in 400 African American live births, incurring annual health care costs of $335 million. SCD can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.These complications lead to significant declines in health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), culminating in early mortality, particularly among AYA. Hydroxyurea, at present, is the main FDA approved medication for SCD that reduces morbidity and mortality, improves HRQoL and lowers healthcare utilization.However, adherence to HU remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among AYA with SCD. Low HU adherence has been associated with worse health outcomes, poor HRQOL and increased healthcare utilization. Low HU adherence is multifactorial, especially in AYA with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. The specific aim for this study is to determine the longitudinal relationship of HU adherence behavior to health-related quality of life, barriers to adherence and habit formation among AYA with SCD.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 68
Est. completion date February 2025
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 21 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients with recent hospitalizations within the past 7 days

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items Numerical value on a scale 0-8 (higher score indicating higher adherence to hydroxyurea) 12 months
Secondary Adherence to Hydroxyurea using Visual Analogue Scale Numerical value on a scale 0-100% (higher score indicating higher adherence to hydroxyurea) 12 months
Secondary Pain score using Patient reported outcomes measurement information system (PROMIS) measure Patient reported outcomes measurement information system (PROMIS) measure for pain intensity, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points (higher T scores indicating worse pain). 12 months
Secondary Fatigue score using Patient reported outcomes measurement information system (PROMIS) measure Patient reported outcomes measurement information system (PROMIS) measure for fatigue, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points (higher T scores indicating worse fatigue). 12 months
Secondary Physical function score using Patient reported outcomes measurement information system (PROMIS) measure Patient reported outcomes measurement information system (PROMIS) measure for physical function, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points (lower T scores indicating worse physical function). 12 months
Secondary Depression score using Patient reported outcomes measurement information system (PROMIS) measure Patient reported outcomes measurement information system (PROMIS) measure for depression, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points (higher T scores indicating worse depression). 12 months
Secondary Anxiety score using Patient reported outcomes measurement information system (PROMIS) measure Patient reported outcomes measurement information system (PROMIS) measure for anxiety, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points (higher T scores indicating worse anxiety). 12 months
Secondary Peer relationships score using Patient reported outcomes measurement information system (PROMIS) measure Patient reported outcomes measurement information system (PROMIS) measure for peer relationships, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points (lower T scores indicating worse peer relationships). 12 months
Secondary Codes and themes from qualitative data analysis Semi-structured interviews focused on HU taking behavior, barriers to adherence and habit formation 12 months
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