Cardiovascular DiseasesNCT00217867
Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization
A study testing Animated character intervention with telephone follow-up in people with Cardiovascular Diseases and Heart Diseases, run by Boston Medical Center at 1 site in United States.
Trial summary
This study will use a comprehensive hospital discharge toolkit to implement up-to-date guidelines for cardiopulmonary diseases. The study will also include a computer-based patient-education program and a telephone-based post-discharge program, both designed for individuals with limited health literacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Animated character intervention with telephone follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the general medical service at Boston Medical Center (BMC)
- Desires to be hospitalized in the future if there is a clinical need
- Able to communicate in English with health providers
Who cannot join
- Transferred from an outside hospital or a specialty services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry)
- Requires hospice, nursing home, or other institutional settings
- Vision that is inadequate to discern the computer-based education and self-management support system
- Hearing that is inadequate to use a telephone
- Unable to independently consent
- Scheduled admission (e.g. for surgery)
- Has sickle cell disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RCT to Reduce Cardiopulmonary Rehospitalization
This study will use a comprehensive hospital discharge toolkit to implement up-to-date guidelines for cardiopulmonary diseases. The study will also include a computer-based patient-education program and a telephone-based post-discharge program, both designed for individuals with limited health literacy. The purpose of this study is to reduce early hospital readmission.
Read the detailed description
BACKGROUND:
Limited health literacy is prevalent in America and has been identified as a cross-cutting priority area for transforming health care quality. This study will explore the effect of innovative patient-education and self-management systems on early rehospitalization for patients admitted to a general medical service.
DESIGN NARRATIVE:
This is a two-armed randomized study of patients with chronic cardiopulmonary diseases in three levels of health literacy. Patients will be tested with the 66 word version of the Rapid Estimate of Adult Literacy in Medicine (REALM) test to allow us to analyze the data according to literacy categories ( 6th grade, 7th-8th grade, and 9th grade). Patients will be randomized to one of the following groups: 1) standard discharge (control group); 2) a experimental group receiving both the case management intervention plus educational and self-management support by Embodied Conversational Agents (ECAs) and post-discharge reinforcement of the discharge plan using a computerized telephone system
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- Animated character intervention with telephone follow-up
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated character intervention with telephone follow-upBehavioural
Animated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual Care, defined as the usual hospital discharge process as delivered by nurses and doctors. |
| 2 | Experimental | Use of animated computerized character to prepare subjects for discharge by reviewing information provided to subjects in a printed After Hospital Care Plan packet, followed by telephone system to reinforce the discharge. Receives: Behavioral: Animated character intervention with telephone follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization
Measured: Measured at 30 days
Secondary outcomes (2)
Subject satisfaction with intervention and hospital experience
Measured: Measured at discharge and 30 days
Subject readiness for discharge
Measured: Measured at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2008
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Brian Jack, Boston Medical Center
- Investigators
- Brian Jack, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217867
- Sponsor's protocol ID
- H-25057
- Other IDs
- R01HL081307
- Status last verified
- Jul 2017
- First submitted
- 19 Sep 2005
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT to Reduce Cardiopulmonary Rehospitalization
- ClinicalTrials.gov ID
- NCT00217867
- Acronym / sponsor ID
- H-25057
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Sep 2005 (estimated)
- 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 will use a comprehensive hospital discharge toolkit to implement up-to-date guidelines for cardiopulmonary diseases. The study will also include a computer-based patient-education program and a telephone-based post-discharge program, both designed for individuals with limited health literacy. The purpose of this study is to reduce early hospital readmission.
Detailed description
BACKGROUND:
Limited health literacy is prevalent in America and has been identified as a cross-cutting priority area for transforming health care quality. This study will explore the effect of innovative patient-education and self-management systems on early rehospitalization for patients admitted to a general medical service.
DESIGN NARRATIVE:
This is a two-armed randomized study of patients with chronic cardiopulmonary diseases in three levels of health literacy. Patients will be tested with the 66 word version of the Rapid Estimate of Adult Literacy in Medicine (REALM) test to allow us to analyze the data according to literacy categories ( 6th grade, 7th-8th grade, and 9th grade). Patients will be randomized to one of the following groups: 1) standard discharge (control group); 2) a experimental group receiving both the case management intervention plus educational and self-management support by Embodied Conversational Agents (ECAs) and post-discharge reinforcement of the discharge plan using a computerized telephone system
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual Care, defined as the usual hospital discharge process as delivered by nurses and doctors. |
| 2 | Experimental | Behavioral: Animated character intervention with telephone follow-upUse of animated computerized character to prepare subjects for discharge by reviewing information provided to subjects in a printed After Hospital Care Plan packet, followed by telephone system to reinforce the discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the general medical service at Boston Medical Center (BMC)
- Desires to be hospitalized in the future if there is a clinical need
- Able to communicate in English with health providers
Key exclusion criteria (7 listed)
- Transferred from an outside hospital or a specialty services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry)
- Requires hospice, nursing home, or other institutional settings
- Vision that is inadequate to discern the computer-based education and self-management support system
- Hearing that is inadequate to use a telephone
- Unable to independently consent
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 |
|---|---|---|
| Animated character intervention with telephone follow-upAnimated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system. | Behavioural | 2 |
Primary outcome
Rehospitalization
Time frame: Measured at 30 days
2 secondary outcomes
Subject satisfaction with intervention and hospital experience
Time frame: Measured at discharge and 30 days
Subject readiness for discharge
Time frame: Measured at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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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.
Brian Jack, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animated character intervention with telephone follow-up in people with Cardiovascular Diseases and Heart Diseases, run by Boston Medical Center at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization (time frame: Measured at 30 days). 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 28 Jul 2017.