NCT01653938

Brief Summary

This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

July 24, 2012

Last Update Submit

November 16, 2020

Conditions

Congestive Heart Failure

Keywords

CHF

Outcome Measures

Primary Outcomes (1)

  • preferences

    preferences for cpr and intubation

    5 minutes after survey

Secondary Outcomes (3)

  • knowledge

    5 minutes after survey

  • decisional conflict

    5 minutes after survey

  • advance care planning documentation

    by the end of one year

Study Arms (2)

control group

NO INTERVENTION

Video Arm

EXPERIMENTAL

Use of video decision aid in the experimental arm.

Behavioral: video decision aid

Interventions

video decision aidBEHAVIORAL
Video Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • A diagnosis of advanced heart failure:
  • New York Heart Association Class III or IV (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest). AND
  • Two or more hospitalizations for heart failure in the last year. AND
  • Either a systolic blood pressure ≤ 120 mm Hg OR Na ≤ 135 mEq/L.
  • Ability to provide informed consent.
  • Ability to communicate in English.
  • Age 65 or older.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 31, 2012

Study Start

April 1, 2011

Primary Completion

September 1, 2012

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

US(1)