NCT01360203

Brief Summary

The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,437

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

May 18, 2011

Last Update Submit

May 10, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 180 day rehospitalization rate

    Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause

    at 180 days post-discharge

Secondary Outcomes (6)

  • 7 day mortality rate

    within 7 days post-discharge

  • Change in quality of Life

    as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge

  • 30 day mortality rate

    at 30 days post-discharge

  • 180 day mortality rate

    at 180 days post-discharge

  • 30 day rehospitalization rate

    at 30 days post-discharge

  • +1 more secondary outcomes

Study Arms (2)

Current Care

NO INTERVENTION

Patients will receive the current care provided to heart failure patients at each of the study sites

Care Transition Intervention

EXPERIMENTAL

Care transition intervention beginning prior to discharge and through six months post-discharge.

Other: Structured Telephone / Remote Outpatient Monitoring

Interventions

Structured Telephone / Remote Outpatient MonitoringOTHER

During their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device.

Also known as: Care Transition Intervention, Care Transitions Intervention, Structured Telephone Monitoring, Remote Monitoring
Care Transition Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients hospitalized at any of the six medical centers who are being actively treated for heart failure.

You may not qualify if:

  • patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,
  • patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,
  • patients with dementia,
  • patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,
  • patients who do not have a working land line phone or reliable cell service,
  • patients on chronic dialysis,
  • patients who cannot identify a usual source of care (free clinic is acceptable) and who will not be assigned a provider upon discharge,
  • patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included), percutaneous coronary intervention
  • patients expected to enroll in hospice or expire after discharge,
  • patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California, Davis

Davis, California, 95616, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

  • Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.

    PMID: 24725308BACKGROUND

  • Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.

    PMID: 26857383DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Michael K Ong, MD, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 25, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 11, 2016

Record last verified: 2014-05

Locations

US(6)