NCT00623571

Brief Summary

Aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with inpatient care in selected elderly patients with acute exacerbation of chronic heart failure (CHF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

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, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
Last Updated

February 26, 2008

Status Verified

January 1, 2004

Enrollment Period

1 year

First QC Date

February 19, 2008

Last Update Submit

February 25, 2008

Conditions

Heart Failure

Keywords

frail elderlyhospital at homeheart failureAcute exacerbation of chronic heart failure

Outcome Measures

Primary Outcomes (1)

  • mortality

    6 months

Secondary Outcomes (1)

  • hospital readmissions

    six months

Study Arms (2)

1

EXPERIMENTAL

Patients treated by hospital-at-home service (GHHS)

Other: Treatment of elderly patients in GHHS

2

ACTIVE COMPARATOR

Patients treated in a general medical ward (GMW)

Other: Treatment of elderly patients in a GMW

Interventions

Treatment of elderly patients in a GMWOTHER
2
Treatment of elderly patients in GHHSOTHER
1

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Acute exacerbation of chronic heart failure,
  • Age over 75,
  • Appropriate care supervision at home,
  • Telephone connection,
  • Living in the hospital-at-home catchment area and informed consent.

You may not qualify if:

  • Absence of family and social support;
  • Patients who need mechanical ventilation,
  • Severe dementia,
  • End-stage cancer,
  • History of severe renal impairment or hepatic failure with ascitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Department of San Giovanni Battista Hospital

Torino, Torino, 10126, Italy

Location

Related Publications (1)

  • Tibaldi V, Isaia G, Scarafiotti C, Gariglio F, Zanocchi M, Bo M, Bergerone S, Ricauda NA. Hospital at home for elderly patients with acute decompensation of chronic heart failure: a prospective randomized controlled trial. Arch Intern Med. 2009 Sep 28;169(17):1569-75. doi: 10.1001/archinternmed.2009.267.

    PMID: 19786675DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 26, 2008

Study Start

April 1, 2004

Primary Completion

April 1, 2005

Study Completion

October 1, 2005

Last Updated

February 26, 2008

Record last verified: 2004-01

Locations

IT(1)