Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App
Primary Purpose
Sickle Cell Disease, Sickle B+ Thalassemia, Sickle Beta Zero Thalassemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HU-Go app
Sponsored by
About this trial
This is an interventional supportive care trial for Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Chronic monthly transfusion support
- Any hemoglobinopathy other than sickle cell disease
Sites / Locations
- Ann & Robert H Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HU-Go app intervention arm
Arm Description
Participants will use HU-Go app intervention arm for a total of 12 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items
Numerical value on a scale 0-8 (higher score indicating higher adherence to hydroxyurea)
Adherence to Hydroxyurea using Visual Analogue Scale
Numerical value on a scale 0-100% (higher score indicating higher adherence to hydroxyurea)
Patient satisfaction with the smartphone app intervention (HU-Go)
Customized patient satisfaction questionnaire, numerical value on a scale 0-10 (higher score indicating higher satisfaction with the app)
HRQOL outcomes
Patient reported outcomes measurement information system (PROMIS) measures, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points. Each HRQOL outcome domain score will be reported separately (higher T scores indicating worse pain, fatigue, depression and anxiety, and lower scores indicating worse physical functioning and peer relationships).
Full Information
NCT ID
NCT04675645
First Posted
August 17, 2016
Last Updated
July 27, 2021
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04675645
Brief Title
Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App
Official Title
Adherence to Hydroxyurea and Health-related Quality of Life in Patients With Sickle Cell Disease: An Intervention Study Using a Smartphone App (HU-Go)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
July 11, 2020 (Actual)
Study Completion Date
July 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Aim 1: Identify the needs, desires, concerns, and expectations of AYA patients with SCD and their parents/caregivers that will guide implementation of a mHealth tool, HU-Go, designed to improve adherence to HU. We will conduct semi-structured interviews with patients and their parents/caregivers. Transcripts will be independently coded and thematic analysis will be conducted.
Hypothesis 1: AYA patients with SCD and their parents/caregivers will identify specific features, content, and usability requirements of HU-Go.
Aim 2: Assess the longitudinal relationship of HU adherence to HRQoL domains, including fatigue and depression. HU adherence will be measured using electronic pill bottles, self-report measures, laboratory markers, and medication possession ratio (MPR). HRQOL will be assessed using PROMIS® measures.
Hypothesis 2: Low HU adherence is associated with impairment of HRQoL domains.
Aim 3: Conduct a single-arm, pilot study to determine the effect size associated with improvement in HU adherence after using HU-Go for 12 weeks. Adherence will be measured using self-report measures, laboratory markers and MPR.
Hypothesis 3: HU-Go will improve HU adherence by at least 20%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sickle B+ Thalassemia, Sickle Beta Zero Thalassemia, Sickle Cell Hemoglobin C
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HU-Go app intervention arm
Arm Type
Other
Arm Description
Participants will use HU-Go app intervention arm for a total of 12 weeks.
Intervention Type
Other
Intervention Name(s)
HU-Go app
Intervention Description
A novel multifunctional mobile app (HU-Go) to improve adherence to hydroxyurea in patients with sickle cell disease
Primary Outcome Measure Information:
Title
Achieving feasibility based on the number of participants completed all study procedures within 6 months of study enrollment
Description
Feasibility is defined as having 80% or more of study participants complete the study within 6 months of enrollment
Time Frame
3 months of study enrollment
Secondary Outcome Measure Information:
Title
Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items
Description
Numerical value on a scale 0-8 (higher score indicating higher adherence to hydroxyurea)
Time Frame
3 months of study enrollment
Title
Adherence to Hydroxyurea using Visual Analogue Scale
Description
Numerical value on a scale 0-100% (higher score indicating higher adherence to hydroxyurea)
Time Frame
3 months of study enrollment
Title
Patient satisfaction with the smartphone app intervention (HU-Go)
Description
Customized patient satisfaction questionnaire, numerical value on a scale 0-10 (higher score indicating higher satisfaction with the app)
Time Frame
3 months of study enrollment
Title
HRQOL outcomes
Description
Patient reported outcomes measurement information system (PROMIS) measures, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points. Each HRQOL outcome domain score will be reported separately (higher T scores indicating worse pain, fatigue, depression and anxiety, and lower scores indicating worse physical functioning and peer relationships).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Chronic monthly transfusion support
Any hemoglobinopathy other than sickle cell disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif M. Badawy, MD, MS
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All patients data will be deidentified.
Learn more about this trial
Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App
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