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NCT Number: NCT04678037

Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobin SC Disease Hemoglobinopathies Sickle B+ Thalassemia Sickle Beta Zero Thalassemia Sickle Cell Hemoglobin C

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROs assessment using sickle cell disease mobile app (SCD-app)

Behavioral

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 outcomes

  1. Feasibility of completing PRO assessments at home using SCD-app (HU-Go)

    Time frame: 6 months

    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 outcomes

  1. Completion rate of PRO assessments at home using SCD-app (HU-Go)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Home-based Assessment of Patient Reported Outcome (PROs) Measures in Sickle Cell Disease (SCD) Using A Smartphone App Platform: A Feasibility Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2020
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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