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Chronic Disease Mobile Educational Experience

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04090593
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Information provided by (Responsible Party):
Los Angeles County Department of Public Health

Brief Summary:
This study evaluates the effectiveness of a mobile health education module, in increasing hospitalized patients' understanding of their chronic illness, and in reducing 30-day hospital readmission rates. Half of the participants will receive the educational module intervention in addition to standard education, the other half will receive hospital standard practice education only.

Condition or disease Intervention/treatment Phase
Chronic Disease Heart Failure Other: Patient Education 101: Mobile Health Education Tool Not Applicable

Detailed Description:

Chronic disease is the leading cause of death and disability, costing the US healthcare system 1 trillion dollars annually. Successful management of these conditions critically requires patient understanding and engagement. Patients are advised to adhere to medications, redesign lifestyles, and navigate the health care system. Most of these care plan items require careful instruction and confirmation of shared understanding.

Mobile health technology has the potential to assist greatly with patient education, especially for hospitalized patients. This prospective study evaluates a specific mobile technology intervention, an educational and emotionally-engaging video patients watch while admitted for a complication related to one of these chronic diseases: Heart Failure, Diabetes, COPD, Asthma, Cirrhosis, Atrial Fibrillation, Hypertension.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study is randomized controlled trial.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator will determine patient eligibility and recruit participants, team will randomize patients to receive intervention vs. current practice. Outcome assessor(s) will be blinded from patient intervention status.
Primary Purpose: Supportive Care
Official Title: Chronic Disease Mobile Educational Experience for Hospitalized Patients
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Educational Module Intervention
Intervention arm patients receive educational mobile module related to chronic condition that contributed to reason for admission.
Other: Patient Education 101: Mobile Health Education Tool
Intervention is interactive, mobile (tablet-or-smart-phone delivered), educational module that patients engage with during hospital admission.

No Intervention: Hospital Practice Control
Control arm patients receive current, standard practice as related to patient education in the hospital (this does not include an educational mobile module).

Primary Outcome Measures :
  1. 30-Day hospital readmission rate [ Time Frame: 9 months (270 days) ]
    In this study, 30-Day hospital readmission rate is defined as the ratio of patients discharged from LAC+USC Medical Center who are readmitted to either LAC+USC Medical Center or one of three other LA County Department of Health Services (DHS) hospitals. (These are Olive View Medical Center, Rancho Los Amigos Hospital, and Harbor-UCLA Medical Center). This rate can be calculated readily by either of two different means: programmed data extraction from the common electronic health record (there is a Power Insight-Cerner report that does this); or blinded, manual chart review.

  2. Self-reported quality of life: Short Form (36) Health Survey [ Time Frame: 9 months (270 days) ]
    As part of the Medical Outcomes Study (MOS), a multi-year, multi-site study to explain variations in patient outcomes, RAND developed the 36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Survey is attached to this submission.

  3. Patient understanding of chronic disease: 8-item disease focused survey. [ Time Frame: 9 months (270 days) ]
    This study's authors have developed an 8-item survey, each question with equal rate, designed to measure patients' understanding of several key concepts related to their diagnosis and management. The higher the score, the better the presumed understanding. Survey for heart failure is attached to this submission.

  4. Patient satisfaction with treatment: Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 9 months (270 days) ]
    The CSQ-8 is an 8-item, easily scored and administered measurement that is designed to measure client satisfaction with services. The items for the CSQ-8 were selected on the basis of ratings by mental health professionals of a number of items that could be related to client satisfaction and by subsequent factor analysis. The CSQ-8 is unidimensional, yielding a homogeneous estimate of general satisfaction with services. The higher the score, the better the presumed patient satisfaction with services. Survey is attached to this submission.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • admission to medical service primary team for decompensation or complication of chronic disease.(e.g. heart failure)

Exclusion Criteria:

  • cognitive disability or visual/auditory limitation that prevents self-interaction with educational module

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 identifier (NCT number): NCT04090593

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Contact: Josh Banerjee, MD, MPH, MS 323-409-6348

Sponsors and Collaborators
Los Angeles County Department of Public Health
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Principal Investigator: Josh Banerjee, MD, MPH, MS LAC+USC Medical Center
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Responsible Party: Los Angeles County Department of Public Health Identifier: NCT04090593    
Other Study ID Numbers: HS-19-00145
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes