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

NCT ID: NCT04678037

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2019-07-21

Brief Summary

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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

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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:

1. 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.
2. 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).
3. 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.

Conditions

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Sickle Cell Disease Sickle Cell Hemoglobin C Sickle Beta Zero Thalassemia Sickle B+ Thalassemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A (PROs assessment every 2 weeks)

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Group A (PROs assessment every 4 weeks)

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Sherif Badawy, MD

Assistant Professor, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherif M Badawy, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 2017-757

Identifier Type: -

Identifier Source: org_study_id