Hospitalization at Home of Elderly Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Treatment of elderly patients in a GMW
Treatment of elderly patients in GHHS
Sponsored by

About this trial
This is an interventional health services research trial for Heart Failure focused on measuring frail elderly, hospital at home, heart failure, Acute exacerbation of chronic heart failure
Eligibility Criteria
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.
Sites / Locations
- Geriatric Department of San Giovanni Battista Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Patients treated by hospital-at-home service (GHHS)
Patients treated in a general medical ward (GMW)
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
hospital readmissions
Full Information
NCT ID
NCT00623571
First Posted
February 19, 2008
Last Updated
February 25, 2008
Sponsor
Azienda Ospedaliera San Giovanni Battista
1. Study Identification
Unique Protocol Identification Number
NCT00623571
Brief Title
Hospitalization at Home of Elderly Patients With Heart Failure
Official Title
Acute Exacerbation of Chronic Heart Failure: "Hospital at Home" Versus Inpatient Care for Elderly Patients. A Randomized, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
frail elderly, hospital at home, heart failure, Acute exacerbation of chronic heart failure
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients treated by hospital-at-home service (GHHS)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients treated in a general medical ward (GMW)
Intervention Type
Other
Intervention Name(s)
Treatment of elderly patients in a GMW
Intervention Type
Other
Intervention Name(s)
Treatment of elderly patients in GHHS
Primary Outcome Measure Information:
Title
mortality
Time Frame
6 months
Secondary Outcome Measure Information:
Title
hospital readmissions
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Geriatric Department of San Giovanni Battista Hospital
City
Torino
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19786675
Citation
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.
Results Reference
derived
Learn more about this trial
Hospitalization at Home of Elderly Patients With Heart Failure
We'll reach out to this number within 24 hrs