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Heart FailureNCT00623571

Hospitalization at Home of Elderly Patients With Heart Failure

A study testing Treatment of elderly patients in a GMW and Treatment of elderly patients in GHHS in people with Heart Failure, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Heart Failure
What is being tested?
Treatment of elderly patients in a GMW and Treatment of elderly patients in GHHS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteItaly
Study dates
Apr 2004to Oct 2005
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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Geriatric Department of San Giovanni Battista Hospital

    Torino, Torino, 10126

Other trials in Italy

About this study

Official title: Acute Exacerbation of Chronic Heart Failure: "Hospital at Home" Versus Inpatient Care for Elderly Patients. A Randomized, Controlled Trial.

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).

Read the detailed description

A total of 101 elderly patients admitted to the emergency department of the hospital for acute exacerbation of CHF were randomly assigned to a general medical ward (GMW, n = 53) or to a geriatric home hospitalization service (GHHS, n = 48).

All patients aged 75 and older admitted to the ED (Emergence Department) of the San Giovanni Battista Hospital during the period between April 2004 and April 2005 with main diagnosis of heart failure and requiring acute hospitalization were enrolled in the study.

Additional inclusion criteria were appropriate care supervision at home, telephone connection, living in the hospital-at-home catchment area and informed consent. Exclusion criteria were 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.

All patients involved underwent a baseline standard clinical evaluation, blood tests that included haematocrits, glycemia, hepatic and renal function and electrolytes, and instrumental investigations. Only those who had been evaluated in the ED for at least 12 to 24 hours were considered eligible for the study.

Patients fulfilling inclusion criteria were informed about the nature of the study and asked to give their informed consent. Extensive information was also provided to patient's relatives to obtain their collaboration.

Directly in the ED, eligible patients were randomly assigned to GHHS or to a GMW and immediately transferred. For the randomization, a set of computer-generated random numbers in a 1:1 ratio has been used. The allocation sequence was unknown to any of the investigators and was contained in a set of sealed envelopes, each bearing on the outside only the name of the hospital and a number.

Measurements of baseline sociodemographic information, clinical data, functional, cognitive and nutritional status, depression and quality of life were obtained for the entire sample.

Patients transferred home were immediately visited by members of the hospital at home's team who conducted a multidimensional geriatric assessment and programmed the home treatment that was the same that hospitalised patients received. In addition, patients treated at home and their caregivers obtained adequate education about the knowledge of the disease and constant advice about smoking cessation, nutrition, use of drugs and early recognition of triggers of disease's exacerbation. The GHHS group received a daily nurse visit and a physician's visit every two or three days for the entire length of stay. The inpatients control group received routine hospital care. Hospital at home staff was available at all times for urgent home visits.

Conditions
Heart Failure
Being tested
Treatment of elderly patients in a GMW, Treatment of elderly patients in GHHS
Keywords
frail elderly, hospital at home, heart failure, Acute exacerbation of chronic heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment of elderly patients in a GMWOther

  • Treatment of elderly patients in GHHSOther

Study groups in NCT00623571
Study groupRoleWhat they receive
1ExperimentalPatients treated by hospital-at-home service (GHHS)
Receives: Other: Treatment of elderly patients in GHHS
2Active comparatorPatients treated in a general medical ward (GMW)
Receives: Other: Treatment of elderly patients in a GMW

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    Measured: 6 months

Secondary outcomes (1)
  1. hospital readmissions

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2008 (estimated)
  2. Study startApr 2004
  3. Primary completionApr 2005
  4. Study completionOct 2005

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00623571
Sponsor's protocol ID
516
Status last verified
Jan 2004
First submitted
19 Feb 2008
Last updated
26 Feb 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19786675

Questions about this trial

What is this clinical trial studying?

A study testing Treatment of elderly patients in a GMW and Treatment of elderly patients in GHHS in people with Heart Failure, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.

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 5 inclusion and 5 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 26 Feb 2008. 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 Italy. 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?

mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00623571, which also lists 1 linked publication.

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 26 Feb 2008.

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