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Completed

NCT Number: NCT00623571

Hospitalization at Home of Elderly Patients With Heart Failure

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).

Completed

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Department of San Giovanni Battista Hospital

Torino, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Treatment of elderly patients in a GMW

Other

Treatment of elderly patients in GHHS

Other

Primary outcomes

  1. mortality

    Time frame: 6 months

Secondary outcomes

  1. hospital readmissions

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Giovanni Battista

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 26, 2008
Registry last updated
Feb 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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