Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease

NCT03629678 | Completed Results

• 2 other identifiers: K23HL141447-2K23HL141447
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

SCD is an inherited disorder of hemoglobin that affects over 100,000 Americans, most of whom live in low-resourced neighborhoods. Acute SCD complications result in 230,000 emergency department visits and $1.5 billion annually in acute-care expenditures. Prior research indicates that increased disease-specific knowledge correlates with improved clinical outcomes in SCD. Thus, targeting strategies to improve disease-specific knowledge is a high priority in the care of individuals with SCD. Significant evidence describes how educational materials, including online educational programs, can be used to increase disease-specific knowledge. In this study, the investigators will evaluate a mobile phone technology intervention based on the prior evidence that technologies can improve SCD-specific knowledge.

Conditions

Sickle Cell Disease

Keywords

mhealth

Outcome Measures

Primary Outcomes (1)

• SCD-specific Knowledge

  Knowledge about SCD. This is a questionnaire that is multiple choice and asks questions about sickle cell disease with one correct answer and 3 incorrect answers. The investigators will sum up the number of correct answers which will be reported. There were a total of 39 questions, so a maximum score of 39. This is not a scale.

  6 months

Secondary Outcomes (4)

• Self-efficacy

  6 months

• Healthcare Utilization (ER Visits and Hospitalizations)

  6 months

• Usage and Usability of the mHealth Application

  6 months

• Patient Activation Measure

  6 months

Study Arms (2)

Control group (Booklets)

NO INTERVENTION

Group 1 will receive the control arm with a paper booklet of the patient-centered SCD-guidelines with education by a health care provider at a single visit

mobile health application

ACTIVE COMPARATOR

Group 2 will receive continuous access to technology-based patient-centered SCD-specific guidelines using a user-driven technological platform, plus a paper booklet of the guidelines with education by a health care provider at a single visit. The mobile app will include interactive content and a fully searchable collection of the SCD-specific guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals.

Other: mobile health application

Interventions

mobile health application OTHER

The user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals.

mobile health application

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• receives care at the community health clinic,
• diagnosis of SCD (Hgb SS, SC, Sβ-thal),
• ability to speak and understand written English
• has access to a smartphone or computer
• between 18-70 years.

You may not qualify if:

• lack of access to a smartphone or computer
• inability to speak and understand written English

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Ohio State University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

The Ohio State University Medical Center

Columbus, Ohio, 43212, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Cronin RM, Quaye N, Liu X, Landes K, Crosby LE, Kassim AA, Volanakis EJ, Schnell PM, DeBaun MR. A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Blood Adv. 2023 Oct 24;7(20):6184-6190. doi: 10.1182/bloodadvances.2023010676.

  PMID: 37595029 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr Robert Cronin
• Organization: The Ohio State University

robert.cronin@osumc.edu

6146889220

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 14, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 14, 2025
• Results First Posted: June 27, 2024

Record last verified: 2025-01

Locations

US (2)