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

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ClinicalTrials.gov Identifier: NCT03629678
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Cronin, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: mobile health application Not Applicable

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.
Other: mobile health application
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.




Primary Outcome Measures :
  1. SCD-specific knowledge [ Time Frame: 6 months ]

    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.



Secondary Outcome Measures :
  1. Patient Activation [ Time Frame: 6 months ]

    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


  2. Self-efficacy [ Time Frame: 6 months ]

    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


  3. Healthcare utilization (ER visits and hospitalizations) [ Time Frame: 6 months ]
    The investigators will measure a count of the # ER visits and # of hospitalizations (i.e., # ER visits + # hospitalizations)

  4. Usage and usability of the mHealth application [ Time Frame: 6 months ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629678


Contacts
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Contact: Robert M Cronin 6159365097 robert.cronin@Vanderbilt.Edu

Locations
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United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Robert Cronin, MD, MS    615-936-5097    robert.cronin@vanderbilt.edu   
Contact: Michael DeBaun, MD, MPH    (615) 875-3040    m.debaun@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center

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Responsible Party: Robert Cronin, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03629678     History of Changes
Other Study ID Numbers: K23HL141447-2
K23HL141447 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Cronin, Vanderbilt University Medical Center:
mhealth
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn