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.
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
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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients treated by hospital-at-home service (GHHS) Receives: Other: Treatment of elderly patients in GHHS |
| 2 | Active comparator | Patients 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.
mortality
Measured: 6 months
Secondary outcomes (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.
- First posted26 Feb 2008 (estimated)
- Study startApr 2004
- Primary completionApr 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exacerbation of Chronic Heart Failure: "Hospital at Home" Versus Inpatient Care for Elderly Patients. A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT00623571
- Acronym / sponsor ID
- 516
- Conditions
- Heart Failure
- Keywords
- frail elderly, hospital at home, heart failure, Acute exacerbation of chronic heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Treatment of elderly patients in GHHSPatients treated by hospital-at-home service (GHHS) |
| 2 | Active comparator | Other: Treatment of elderly patients in a GMWPatients treated in a general medical ward (GMW) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of elderly patients in a GMW | Other | 2 |
| Treatment of elderly patients in GHHS | Other | 1 |
Primary outcome
mortality
Time frame: 6 months
1 secondary outcome
hospital readmissions
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2008.
- Derived from this study: PubMed 19786675Tibaldi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.