Congestive Heart FailureNCT00235404
Randomized Controlled Trial of Health Care to Elderly Patients.
A study testing Multicomponent treatment in people with Congestive Heart Failure and Angina Pectoris, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
To study the efficacy of multicomponent treatment and care for patients with acute illness or deterioration of a chronic disease at a nursing home in primary health care compared to traditional treatment at hospital. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Congestive Heart Failure, Angina Pectoris, Asthma
- What is being tested?
- Multicomponent treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2003to May 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique.
Who cannot join
- Participating doctors at the hospital together with general practitioners shall develope exclusion criteria through Delphi technique.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Faculty of Medicine, The Norwegian University of Science and Technology (NTNU)
Trondheim, 7489
About this study
Official title: Specialized Treatment and Care Intervention at a Primary Level in a Nursing Home Compared to Conventional Treatment at a Hospital: a Randomized Controlled Trial.
To study the efficacy of multicomponent treatment and care for patients with acute illness or deterioration of a chronic disease at a nursing home in primary health care compared to traditional treatment at hospital.
Read the detailed description
Managers at St. Olavs University Hospital and the City of Trondheim local authority decided in 2001 to establish a reinforced department at a nursing home with a multicomponent approach to patient treatment.
In the study treatment at a nursing home will be compared with conventional treatment in ordinary hospital beds in medical, surgical and orthopedic departments at a hospital. Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique. Eligible participants will be hospitalized from their ordinary home and expected to return to home after treatment. When an eligible patient is identified and accepted for inclusion, randomization will be performed by the Clinical Research Department at the Faculty of Medicine.
- Conditions
- Congestive Heart Failure, Angina Pectoris, Asthma, Pneumonia, Fractures
- Being tested
- Multicomponent treatment, usual care
- Keywords
- Treatment of elderly., Nursing home., Rehabilitation., Readmissions.
- Medical subject headings
- Heart Failure, Angina Pectoris, Asthma, Pneumonia, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent treatmentOther
Specialized care in preparing recharge to home
usual careOther
Usual recharge directly from hospital to home
| Study group | Role | What they receive |
|---|---|---|
| Intermediate community hospital | Experimental | Not described Receives: Other: Multicomponent treatment |
| Usual care | Active comparator | Not described Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of readmissions
Measured: Within 60 days
Number of deaths
Measured: Within 12 months
Need of home nursing services
Measured: within 12 months
Secondary outcomes (1)
Costs
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startSep 2003
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Roar Johnsen, Study chair, The Norwegian University of Science and Technology (NTNU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235404
- Sponsor's protocol ID
- REK 037-03
- Status last verified
- Jul 2016
- First submitted
- 7 Oct 2005
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Garasen H, Windspoll R, Johnsen R. Intermediate care at a community hospital as an alternative to prolonged general hospital care for elderly patients: a randomised controlled trial. BMC Public Health. 2007 May 2;7:68. doi: 10.1186/1471-2458-7-68.
PubMed 17475006Garasen H, Magnussen J, Windspoll R, Johnsen R. [Elderly patients in hospital or in an intermediate nursing home department--cost analysis]. Tidsskr Nor Laegeforen. 2008 Jan 31;128(3):283-5. Norwegian.
PubMed 18264150Garasen H, Windspoll R, Johnsen R. Long-term patients' outcomes after intermediate care at a community hospital for elderly patients: 12-month follow-up of a randomized controlled trial. Scand J Public Health. 2008 Mar;36(2):197-204. doi: 10.1177/1403494808089685.
PubMed 18519285
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Treatment and Care Intervention at a Primary Level in a Nursing Home Compared to Conventional Treatment at a Hospital: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00235404
- Acronym / sponsor ID
- REK 037-03
- Conditions
- Congestive Heart Failure, Angina Pectoris, Asthma, Pneumonia, Fractures
- Keywords
- Treatment of elderly., Nursing home., Rehabilitation., Readmissions.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- Sep 2003
- Study completion
- May 2005 (actual)
- First posted
- 10 Oct 2005 (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.
To study the efficacy of multicomponent treatment and care for patients with acute illness or deterioration of a chronic disease at a nursing home in primary health care compared to traditional treatment at hospital.
Detailed description
Managers at St. Olavs University Hospital and the City of Trondheim local authority decided in 2001 to establish a reinforced department at a nursing home with a multicomponent approach to patient treatment.
In the study treatment at a nursing home will be compared with conventional treatment in ordinary hospital beds in medical, surgical and orthopedic departments at a hospital. Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique. Eligible participants will be hospitalized from their ordinary home and expected to return to home after treatment. When an eligible patient is identified and accepted for inclusion, randomization will be performed by the Clinical Research Department at the Faculty of Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermediate community hospital | Experimental | Other: Multicomponent treatment |
| Usual care | Active comparator | Other: usual care |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique.
Key exclusion criteria (1 listed)
- Participating doctors at the hospital together with general practitioners shall develope exclusion criteria through Delphi technique.
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 |
|---|---|---|
| Multicomponent treatmentSpecialized care in preparing recharge to home | Other | Intermediate community hospital |
| usual careUsual recharge directly from hospital to home | Other | Usual care |
Primary outcome
Number of readmissions
Time frame: Within 60 days
Number of deaths
Time frame: Within 12 months
Need of home nursing services
Time frame: within 12 months
1 secondary outcome
Costs
Time frame: Within 12 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 29 Jul 2016.
- Results publication: PubMed 17475006Garasen H, Windspoll R, Johnsen R. Intermediate care at a community hospital as an alternative to prolonged general hospital care for elderly patients: a randomised controlled trial. BMC Public Health. 2007 May 2;7:68. doi: 10.1186/1471-2458-7-68.
- Results publication: PubMed 18264150Garasen H, Magnussen J, Windspoll R, Johnsen R. [Elderly patients in hospital or in an intermediate nursing home department--cost analysis]. Tidsskr Nor Laegeforen. 2008 Jan 31;128(3):283-5. Norwegian.
- Results publication: PubMed 18519285Garasen H, Windspoll R, Johnsen R. Long-term patients' outcomes after intermediate care at a community hospital for elderly patients: 12-month follow-up of a randomized controlled trial. Scand J Public Health. 2008 Mar;36(2):197-204. doi: 10.1177/1403494808089685.
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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.
Roar Johnsen study chair
The Norwegian University of Science and Technology (NTNU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent treatment in people with Congestive Heart Failure and Angina Pectoris, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 29 Jul 2016. 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 Norway. 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?
Number of readmissions (time frame: Within 60 days). The study lists 3 primary outcomes in all. 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 NCT00235404, which also lists 3 linked publications.
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 29 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.