Back to resultsChronic Disease Mobile Educational Experience
Primary Purpose
Chronic Disease, Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient Education 101: Mobile Health Education Tool
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational Module Intervention
Hospital Practice Control
Arm Description
Intervention arm patients receive educational mobile module related to chronic condition that contributed to reason for admission.
Control arm patients receive current, standard practice as related to patient education in the hospital (this does not include an educational mobile module).
Outcomes
Primary Outcome Measures
30-Day hospital readmission rate
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.
Self-reported quality of life: Short Form (36) Health Survey
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.
Patient understanding of chronic disease: 8-item disease focused survey.
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.
Patient satisfaction with treatment: Client Satisfaction Questionnaire (CSQ-8)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04090593
First Posted
August 13, 2019
Last Updated
September 12, 2019
Sponsor
Los Angeles County Department of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT04090593
Brief Title
Chronic Disease Mobile Educational Experience
Official Title
Chronic Disease Mobile Educational Experience for Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Los Angeles County Department of Public Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study is randomized controlled trial.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational Module Intervention
Arm Type
Experimental
Arm Description
Intervention arm patients receive educational mobile module related to chronic condition that contributed to reason for admission.
Arm Title
Hospital Practice Control
Arm Type
No Intervention
Arm Description
Control arm patients receive current, standard practice as related to patient education in the hospital (this does not include an educational mobile module).
Intervention Type
Other
Intervention Name(s)
Patient Education 101: Mobile Health Education Tool
Intervention Description
Intervention is interactive, mobile (tablet-or-smart-phone delivered), educational module that patients engage with during hospital admission.
Primary Outcome Measure Information:
Title
30-Day hospital readmission rate
Description
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.
Time Frame
9 months (270 days)
Title
Self-reported quality of life: Short Form (36) Health Survey
Description
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.
Time Frame
9 months (270 days)
Title
Patient understanding of chronic disease: 8-item disease focused survey.
Description
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.
Time Frame
9 months (270 days)
Title
Patient satisfaction with treatment: Client Satisfaction Questionnaire (CSQ-8)
Description
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.
Time Frame
9 months (270 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josh Banerjee, MD, MPH, MS
Phone
323-409-6348
Email
jbanerjee@dhs.lacounty.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josh Banerjee, MD, MPH, MS
Organizational Affiliation
LAC+USC Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Chronic Disease Mobile Educational Experience
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