- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00623571
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Torino, Italy, 10126
- Geriatric Department of San Giovanni Battista Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Patients treated by hospital-at-home service (GHHS)
|
|
Active Comparator: 2
Patients treated in a general medical ward (GMW)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hospital readmissions
Time Frame: six months
|
six months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 516
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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