Hospitalization at Home of Elderly Patients With Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00623571
First received: February 19, 2008
Last updated: February 25, 2008
Last verified: January 2004

February 19, 2008
February 25, 2008
April 2004
April 2005   (final data collection date for primary outcome measure)
mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00623571 on ClinicalTrials.gov Archive Site
hospital readmissions [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hospitalization at Home of Elderly Patients With Heart Failure
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Heart Failure
  • Other: Treatment of elderly patients in a GMW
  • Other: Treatment of elderly patients in GHHS
  • Experimental: 1
    Patients treated by hospital-at-home service (GHHS)
    Intervention: Other: Treatment of elderly patients in GHHS
  • Active Comparator: 2
    Patients treated in a general medical ward (GMW)
    Intervention: Other: Treatment of elderly patients in a GMW
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
October 2005
April 2005   (final data collection date for primary outcome measure)

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.
Both
75 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00623571
516
No
Not Provided
Azienda Ospedaliera San Giovanni Battista
Not Provided
Not Provided
Azienda Ospedaliera San Giovanni Battista
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP