- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03629678
Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sickle cell disease (SCD) is an inherited blood disorder that affects over 100,000 Americans, an underserved population with low life expectancy and risk for significant and life-threatening medical complications (e.g., stroke). Adults with SCD are overwhelmingly members of socially disadvantaged groups, increasing their risk for disparities in care. Annual health expenditure for individuals with SCD in the United States is about $1.5 billion, primarily from multiple emergency room visits (230,000 visits/year) for management of acute complications. Use of disease-specific knowledge has emerged as a powerful tool to decrease health care utilization. Significant evidence has described how to increase disease-specific knowledge using educational materials, including online educational programs in individuals managing chronic diseases, including SCD. Patient knowledge and use of disease-specific information like evidence-based clinical guidelines has the potential to decrease health care utilization. In 2014, the National Heart, Lung, and Blood Institute (NHLBI) published guidelines for evidence-based management of SCD for health care providers. However, to date, no national strategy has been developed to make these guidelines patient-centered, accessible, and actionable for adults with SCD. Federal Meaningful Use regulations have recommended using health-related technologies to improve patient access to their health information to promote patient engagement. Yet, many adults with SCD are not yet fully engaged in use of health technologies because they are unsure of the best format (e.g., mobile or web-based), leading to a health care technology gap. Mobile health applications (apps) that include patient-centered care guidelines could engage and activate this population given the high use of mobile technologies, potentially closing this health technology gap and improving health outcomes.
Evaluate the feasibility and acceptability of the refined iManage in a pilot study with adults with SCD. The investigators will recruit 50 adults from the population of 250 adults with SCD at the Vanderbilt Meharry Sickle Cell Disease Center of Excellence and the ohio state university comprehensive sickle cell center for a 6-month pilot study to evaluate usability, acceptance, and usage. At the end of the study, the investigators will conduct interviews with a subset of participants to gain an in-depth understanding of usage patterns and how to sustain engagement to promote ongoing app use.
Evaluate the efficacy of the refined iManage app on SCD-specific knowledge. The investigators will test the hypothesis that the refined iManage will increase SCD-specific knowledge by measuring SCD-specific knowledge at the start and end of the 6-month pilot study. the investigators will conduct exploratory analyses of secondary outcomes including patient activation, adherence to guidelines, missed days of school/work, and self-efficacy.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43212
- The Ohio State University Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- lack of access to a smartphone or computer
- inability to speak and understand written English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control group (Booklets)
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
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Active Comparator: mobile health application
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SCD-specific knowledge
Time Frame: 6 months
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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 to determine a score of the measure out of 100%. This is not a scale. |
6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Activation
Time Frame: 6 months
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Patient activation measure - this is a scale as described by Hibbard et al in Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39(4 Pt 1):1005-26. Scale is 0-100, higher score is better Scale has no subscales and measures patient activation |
6 months
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Self-efficacy
Time Frame: 6 months
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sickle cell self-efficacy scale, as described in Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000;38(9):951-63. Scale is 0-45, higher score is better Scale has no subscales and measures self-efficacy |
6 months
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Healthcare utilization (ER visits and hospitalizations)
Time Frame: 6 months
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The investigators will measure a count of the # ER visits and # of hospitalizations (i.e., # ER visits + # hospitalizations)
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6 months
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Usage and usability of the mHealth application
Time Frame: 6 months
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How often app and functionality was used. Usability will be measured by the widely used and validated System Usability Scale as described in Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996;189(194):4-7. The mobile health application for the guidelines has built-in tracking of the number of times the application is launched, how many times each of the functions are used, and how many times each button has been pushed. To measure usage, the investigators will record the numbers of each of these events for each participant. In addition to total use, the investigators will measure usage over time including any use, initial use, periodic use, and sustained use. SUS scale is 0-100, higher score is better. Scale has no subscales and measures usability of the app |
6 months
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23HL141447-2
- K23HL141447 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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