An mHealth Strategy to Improve Medication Adherence in Ad... | NCT04688411

Studies
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease

NCT04688411

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Recruiting

Last Update Posted

Nov 20, 2024Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

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

Interventions

MED-Go App

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1K23HL150232	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2020Actual

Primary Completion Date

Feb 1, 2025Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Dec 24, 2020

First Submission Date that Met QC Criteria

Dec 24, 2020

First Posted Date

Dec 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2024

Last Update Posted Date

Nov 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherif Badawy, MD, Assistant Professor, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant, Ann & Robert H Lurie Children's Hospital of ChicagoPrincipal Investigator

Lead Sponsor

Ann & Robert H Lurie Children's Hospital of ChicagoOTHER

Collaborators

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to evaluate a potential behavioral intervention (MED-Go app). To meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of MED-Go app in adolescents and young adults (AYA) with sickle cell disease (SCD). The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.

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 (HU), 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. AYA have adopted text messaging and smartphone apps at a fast pace, including those who have SCD.Existing evidence indicates that mobile health (mHealth) behavioral interventions are feasible and acceptable with modest efficacy at improving medication adherence and self-management in AYA, including SCD. The specific aim for this study is to test the feasibility and acceptability of the MED-Go app as an mHealth behavioral intervention to improve HU adherence among AYA with SCD.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MED-Go app Intervention	Other	Participants will use MED-Go app intervention for a total of 12 weeks	Behavioral: MED-Go App
Control Arm	No Intervention	Standard of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MED-Go App	Behavioral	A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease	MED-Go app Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients achieving feasibility criteria of using the MED-Go app	Feasibility is defined as 70% of participants logging their daily HU 70% of the time over 12 weeks or 59 out of 84 study days. This will be reported as a dichotomous outcome, either yes or no.	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Scores of System Usability Scale (SUS)	App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)	12 weeks
Hydroxyurea adherence rates

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 12-21 years old
Any sickle cell disease genotype
On steady state of hydroxyurea for 2 months
Own of have access to a smartphone during the study period

Exclusion Criteria:

Recent hospitalizations within the past 7 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherif M Badawy, MD, MS	Contact	(312) 227-4836		sbadawy@luriechildrens.org
Savannah Winkler, BS	Contact	(312) 227-4807		swinkler@luriechildrens.org

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ann & Robert H Lurie Children's Hospital of Chicago	Recruiting	Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

All patient data will be deidentified

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell
D006450	Hemoglobin SC Disease

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

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