COPDCOPD-HOMENCT00702078
Home-based Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing closer collaboration between hospital and primary healthcare system in people with COPD, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Read more about this study
- Who is it for?
- Ages Up to 95 years
- Conditions the study is for
- COPD
- What is being tested?
- closer collaboration between hospital and primary healthcare system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2008to Dec 2015
- 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 Up to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of COPD (III-IV)
- receive help from homecare nurse
- not suffering from any other serious disease, with expected lifespan less than 6 months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.
We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.
The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.
- Conditions
- COPD
- Being tested
- closer collaboration between hospital and primary healthcare system, usual care
- Keywords
- COPD, home-based treatment, early intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closer collaboration between hospital and primary healthcare systemBehavioural
Follow-up from the hospital and the primary healthcare in cooperation
usual careBehavioural
follow-up according to todays best practice
| Study group | Role | What they receive |
|---|---|---|
| usual care | Other | follow-up according to todays best practice. Receives: Behavioral: usual care |
| cooperation | Experimental | Follow-up from the hospital and the primary healthcare in cooperation Receives: Behavioral: closer collaboration between hospital and primary healthcare system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalizations
Measured: 2011
Secondary outcomes (4)
quality of life
Measured: 2011
lung function
Measured: 2011
use of medication
Measured: 2011
cost-effectiveness
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2015
- Study completionDec 2015
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 COPDStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Community Health Network
- Responsible party
- Sponsor
- Investigators
- Anne Hildur Henriksen, MD,PhD, Study chair, St.Olavs Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702078
- Sponsor's protocol ID
- 17417
- Acronym
- COPD-HOME
- Status last verified
- Jan 2017
- First submitted
- 19 Jun 2008
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Titova E, Salvesen O, Bentsen SB, Sunde S, Steinshamn S, Henriksen AH. Does an Integrated Care Intervention for COPD Patients Have Long-Term Effects on Quality of Life and Patient Activation? A Prospective, Open, Controlled Single-Center Intervention Study. PLoS One. 2017 Jan 6;12(1):e0167887. doi: 10.1371/journal.pone.0167887. eCollection 2017.
PubMed 28060921
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Study on the Effect of Home-based Treatment of Patients With COPD. Improved Cooperation Between Hospital and Primary Healthcare System.
- ClinicalTrials.gov ID
- NCT00702078
- Acronym / sponsor ID
- COPD-HOME / 17417
- Conditions
- COPD
- Keywords
- COPD, home-based treatment, early intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Community Health Network
- Study start
- Apr 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jun 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.
We want to improve the treatment of patients suffering from COPD (3-4) by early medical intervention in the patients home. A close cooperation between the hospital and the primary healthcare system will hopefully reduce hospitalisation, drug consumption and improve quality of life. Following up from the hospital and the primary healthcare in cooperation may lead to earlier detection and treatment of exacerbations in COPD.
The main outcome variable will be number of hospitalizations assessed simply by counting. The second objective will be Quality of life and activation assessed by different questionnaires included in St.George´s Respiratory Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | Other | Behavioral: usual carefollow-up according to todays best practice. |
| cooperation | Experimental | Behavioral: closer collaboration between hospital and primary healthcare systemFollow-up from the hospital and the primary healthcare in cooperation |
Who may qualify
- Ages
- Up to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of COPD (III-IV)
- receive help from homecare nurse
- not suffering from any other serious disease, with expected lifespan less than 6 months
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| closer collaboration between hospital and primary healthcare systemFollow-up from the hospital and the primary healthcare in cooperation | Behavioural | cooperation |
| usual carefollow-up according to todays best practice | Behavioural | usual care |
Primary outcome
Number of hospitalizations
Time frame: 2011
4 secondary outcomes
quality of life
Time frame: 2011
lung function
Time frame: 2011
use of medication
Time frame: 2011
cost-effectiveness
Time frame: 2011
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 11 Jan 2017.
- Results publication: PubMed 28060921Titova E, Salvesen O, Bentsen SB, Sunde S, Steinshamn S, Henriksen AH. Does an Integrated Care Intervention for COPD Patients Have Long-Term Effects on Quality of Life and Patient Activation? A Prospective, Open, Controlled Single-Center Intervention Study. PLoS One. 2017 Jan 6;12(1):e0167887. doi: 10.1371/journal.pone.0167887. eCollection 2017.
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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.
Anne Hildur Henriksen, MD,PhD study chair
St.Olavs Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closer collaboration between hospital and primary healthcare system in people with COPD, run by St. Olavs Hospital 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 3 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 11 Jan 2017. 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 hospitalizations (time frame: 2011). 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 NCT00702078, 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 11 Jan 2017.