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

September 8, 2023 updated by: Sherif Badawy, MD, Ann & Robert H Lurie Children's Hospital of Chicago

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HU-Go app intervention arm
Participants will use the HU-Go app intervention arm for 12 months.
Other: HU-Go app
A novel multifunctional mobile app (HU-Go) to improve adherence to hydroxyurea in patients with sickle cell disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydroxyurea adherence rate
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items
Time Frame: 12 months
Numerical value on a scale 0-8 (higher score indicating higher adherence to hydroxyurea)
12 months
Adherence to Hydroxyurea using Visual Analogue Scale
Time Frame: 12 months
Numerical value on a scale 0-100% (higher score indicating higher adherence to hydroxyurea)
12 months
Pain score using Patient reported outcomes measurement information system (PROMIS) measure
Time Frame: 12 months
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
Fatigue score using Patient reported outcomes measurement information system (PROMIS) measure
Time Frame: 12 months
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
Physical function score using Patient reported outcomes measurement information system (PROMIS) measure
Time Frame: 12 months
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
Depression score using Patient reported outcomes measurement information system (PROMIS) measure
Time Frame: 12 months
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
Anxiety score using Patient reported outcomes measurement information system (PROMIS) measure
Time Frame: 12 months
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
Peer relationships score using Patient reported outcomes measurement information system (PROMIS) measure
Time Frame: 12 months
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
Codes and themes from qualitative data analysis
Time Frame: 12 months
Semi-structured interviews focused on HU taking behavior, barriers to adherence and habit formation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Sherif M. Badawy, MD, MS, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

December 24, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2020-3366
  • 1K23HL150232 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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