- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090593
Chronic Disease Mobile Educational Experience
Chronic Disease Mobile Educational Experience for Hospitalized Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Josh Banerjee, MD, MPH, MS
- Phone Number: 323-409-6348
- Email: jbanerjee@dhs.lacounty.gov
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational Module Intervention
Intervention arm patients receive educational mobile module related to chronic condition that contributed to reason for admission.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
9 months (270 days)
|
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.
|
9 months (270 days)
|
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.
|
9 months (270 days)
|
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.
|
9 months (270 days)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Josh Banerjee, MD, MPH, MS, LAC+USC Medical Center
Study record dates
Study Major Dates
Study Start (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-19-00145
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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