Chronic DiseaseNCT04090593
Chronic Disease Mobile Educational Experience
A study testing Patient Education 101: Mobile Health Education Tool in people with Chronic Disease and Heart Failure, run by Los Angeles County Department of Public Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Disease, Heart Failure
- What is being tested?
- Patient Education 101: Mobile Health Education Tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to medical service primary team for decompensation or complication of chronic disease.(e.g. heart failure)
Who cannot join
- cognitive disability or visual/auditory limitation that prevents self-interaction with educational module
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chronic Disease Mobile Educational Experience for Hospitalized Patients
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.
Read the 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.
- Conditions
- Chronic Disease, Heart Failure
- Being tested
- Patient Education 101: Mobile Health Education Tool
- Medical subject headings
- Chronic Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education 101: Mobile Health Education ToolOther
Intervention is interactive, mobile (tablet-or-smart-phone delivered), educational module that patients engage with during hospital admission.
| Study group | Role | What they receive |
|---|---|---|
| Educational Module Intervention | Experimental | Intervention arm patients receive educational mobile module related to chronic condition that contributed to reason for admission. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months (270 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study is randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Los Angeles County Department of Public Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Josh Banerjee, MD, MPH, MS, Principal investigator, LAC+USC Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090593
- Sponsor's protocol ID
- HS-19-00145
- Status last verified
- Sep 2019
- First submitted
- 13 Aug 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Disease Mobile Educational Experience for Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04090593
- Acronym / sponsor ID
- HS-19-00145
- Conditions
- Chronic Disease, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Los Angeles County Department of Public HealthOther government
- Study start
- Sep 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study is randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Educational Module Intervention | Experimental | Other: Patient Education 101: Mobile Health Education ToolIntervention arm patients receive educational mobile module related to chronic condition that contributed to reason for admission. |
| 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- admission to medical service primary team for decompensation or complication of chronic disease.(e.g. heart failure)
Key exclusion criteria (1 listed)
- cognitive disability or visual/auditory limitation that prevents self-interaction with educational module
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Education 101: Mobile Health Education ToolIntervention is interactive, mobile (tablet-or-smart-phone delivered), educational module that patients engage with during hospital admission. | Other | Educational Module Intervention |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Banerjee, MD, MPH, MS principal investigator
LAC+USC Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education 101: Mobile Health Education Tool in people with Chronic Disease and Heart Failure, run by Los Angeles County Department of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josh Banerjee, MD, MPH, MS (323-409-6348, jbanerjee@dhs.lacounty.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day hospital readmission rate (time frame: 9 months (270 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019; AzTrials last refreshed its copy on 28 Oct 2026.