Educational and Supportive Interventions to Prevent Cardi... | NCT00217867

Studies
Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization

NCT00217867

Sponsor

Boston Medical Center

Status

Completed

Last Update Posted

Jul 28, 2017Actual

Enrollment

832Actual

Phase

Not Applicable

Conditions

Cardiovascular Diseases
Heart Diseases

Interventions

Animated character intervention with telephone follow-up

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL081307	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Apr 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Sep 19, 2005

First Submission Date that Met QC Criteria

Sep 19, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2017

Last Update Posted Date

Jul 28, 2017Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

832Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Behavioral: Animated character intervention with telephone follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Animated character intervention with telephone follow-up	Behavioral	Animated character will teach the discharge plan before discharge, then this teaching will be reinforced by computerized telephone system.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rehospitalization		Measured at 30 days

Secondary Outcomes

Measure	Description	Time Frame
Subject satisfaction with intervention and hospital experience		Measured at discharge and 30 days
Subject readiness for discharge		Measured at 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Jack, MD	Boston Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Medical Center		Boston	Massachusetts	02118	United States

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided