Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study
Primary Purpose
Sickle Cell Disease, Sickle Cell Hemoglobin C, Sickle Beta Zero Thalassemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROs assessment using sickle cell disease mobile app (SCD-app)
Sponsored by
About this trial
This is an interventional supportive care trial for Sickle Cell Disease
Eligibility Criteria
Inclusion Criteria:
- Age 12 years or older at the time of study enrollment;
- SCD diagnosis (all genotypes) confirmed by hemoglobin electrophoresis;
- Own or have access to a smartphone or a tablet; and
- Speak and read English.
Exclusion Criteria:
- Patients or caregivers with cognitive impairment;
- Patients or caregivers physical impairment; and
- Patients or caregivers who will not be able to complete study assessments.
Sites / Locations
- Ann & Robert H. Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A (PROs assessment every 2 weeks)
Group A (PROs assessment every 4 weeks)
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of completing PRO assessments at home using SCD-app (HU-Go)
Having an overall completion rate of ≥ 50% for all study participants (Group A and B). This will be reported as a dichotomous outcome, either yes or no. The percentage (%) completion rate will be calculated as the number of PROs assessments completed divided by the number of PROs assessments expected over the study period.
Secondary Outcome Measures
Completion rate of PRO assessments at home using SCD-app (HU-Go)
Completion rate of different PRO assessments at home using PROMIS®-CAT measures among patients with SCD and/or their parents. PRO assessments are planned to be every 2 weeks in Group 1 and every 4 weeks in Group 2. This outcome will be calculated and reported as percent (%) completion rate.
Full Information
NCT ID
NCT04678037
First Posted
December 3, 2020
Last Updated
December 17, 2020
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04678037
Brief Title
Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study
Official Title
Home-based Assessment of Patient Reported Outcome (PROs) Measures in Sickle Cell Disease (SCD) Using A Smartphone App Platform: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
July 21, 2019 (Actual)
Study Completion Date
July 21, 2019 (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
The overarching goal of this proposal is to identify modifiable behavioral strategies based on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) that will improve hydroxyurea (HU) adherence among adolescents and young adults with sickle cell disease (SCD). In this proposed study, we intend to test the functionality of a PROs-toolbox feature, which will be integrated into our existing smartphone application platform (SCD-app), over a 24-week period in a cohort of SCD patients and their caregivers.
Detailed Description
Adherence to hydroxyurea is a multi-factorial dynamic process, and, to date, predictors for changes in adherence levels over time remain unclear. Changes in HRQOL data could serve as surrogate markers for changes in hydroxyurea adherence over time, and could suggest when patients might or might not need or benefit from an intervention based on worse or better HRQOL scores, respectively.
The main hypothesis of this study is that the assessment of patients' HRQOL at home using a SCD smartphone application platform (app) is feasible and acceptable, and that less frequent assessments of HRQOL at home will have an overall higher completion rate when compared to more frequent ones. We plan to assess HRQOL using the NIH-developed patient reported outcomes measurement information system (PROMIS®) with computerized adaptive testing (CAT) approach. PROMIS®-CAT approach is a reliable and valid PROs assessment platform that has been used in limited studies in SCD.
The study will include the following specific aims:
To evaluate the feasibility and acceptability of the assessment of patients HRQOL at home using smartphones with PROMIS®-CAT measures integrated into a SCD-app.
To examine the effect of the frequency of required HRQOL assessments on participants' completion rate over 24-week period with HRQOL evaluated every 2 weeks (Group 1) versus every 4 weeks (Group 2).
To explore participants' experience and preferences with the process and the frequency of HRQOL assessment at home using their smartphones with PROMIS®-CAT measures integrated into a SCD-app.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sickle Cell Hemoglobin C, Sickle Beta Zero Thalassemia, Sickle B+ Thalassemia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (PROs assessment every 2 weeks)
Arm Type
Active Comparator
Arm Title
Group A (PROs assessment every 4 weeks)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
PROs assessment using sickle cell disease mobile app (SCD-app)
Intervention Description
A smartphone app platform designed for patients with sickle cell disease. The SCD-app is programmed to send notification to patients to complete PROs assessment. The SCD-app is able to collect PROs data as patients complete the assessment using the app platform.
Primary Outcome Measure Information:
Title
Feasibility of completing PRO assessments at home using SCD-app (HU-Go)
Description
Having an overall completion rate of ≥ 50% for all study participants (Group A and B). This will be reported as a dichotomous outcome, either yes or no. The percentage (%) completion rate will be calculated as the number of PROs assessments completed divided by the number of PROs assessments expected over the study period.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Completion rate of PRO assessments at home using SCD-app (HU-Go)
Description
Completion rate of different PRO assessments at home using PROMIS®-CAT measures among patients with SCD and/or their parents. PRO assessments are planned to be every 2 weeks in Group 1 and every 4 weeks in Group 2. This outcome will be calculated and reported as percent (%) completion rate.
Time Frame
6 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:
Age 12 years or older at the time of study enrollment;
SCD diagnosis (all genotypes) confirmed by hemoglobin electrophoresis;
Own or have access to a smartphone or a tablet; and
Speak and read English.
Exclusion Criteria:
Patients or caregivers with cognitive impairment;
Patients or caregivers physical impairment; and
Patients or caregivers who will not be able to complete study assessments.
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 study data are de-identified and will be analysed as aggregate.
Learn more about this trial
Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study
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