NCT04090593

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

August 13, 2019

Last Update Submit

September 12, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    9 months (270 days)

  • 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.

    9 months (270 days)

  • 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.

    9 months (270 days)

  • 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.

    9 months (270 days)

Study Arms (2)

Educational Module Intervention

EXPERIMENTAL

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

Hospital Practice Control

NO INTERVENTION

Control arm patients receive current, standard practice as related to patient education in the hospital (this does not include an educational mobile module).

Interventions

Intervention is interactive, mobile (tablet-or-smart-phone delivered), educational module that patients engage with during hospital admission.

Educational Module Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic DiseaseHeart Failure

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Josh Banerjee, MD, MPH, MS

    LAC+USC Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Josh Banerjee, MD, MPH, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Study is randomized controlled trial.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

September 16, 2019

Study Start

September 1, 2019

Primary Completion

June 1, 2020

Study Completion

October 1, 2020

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share