Pulmonary Disease Chronic ObstructiveNCT00648609
Community Based Self Management of COPD Facilitated by a Palliative Care Team:Impact on Health Care Utilization and QOL
An observational study of Pulmonary Disease Chronic Obstructive, run by Essentia Health at 1 site in United States.
Trial summary
The purpose of this study is to compare in home support services for patients with COPD with usual care. The study is designed to evaluate the impact of an interdisciplinary palliative care team on community based self management of advanced COPD. A total of thirty patients will be enrolled into this study. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pulmonary Disease Chronic Obstructive
- What is being tested?
- Palliative home care in advanced COPD
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2009
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced COPD from St. Mary's Duluth Clinic Health Systrem population in Duluth Minnesota
Who may be able to join
- Age 60 or greater
- Dx of COPD
- Received 2 or more unscheduled acute care visits during the 12 months from Jan 2007-Dec 2007
- SMDC primary care provider
- Lives within 50 miles of Duluth Minnesota
- Informed consent
Who cannot join
- Non English speaking
- Too ill or cognitively impaired to provide baseline data or informed consent
- Lives more than 50 miles from Duluth
- Nursing home resident
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare in home support services for patients with COPD with usual care. The study is designed to evaluate the impact of an interdisciplinary palliative care team on community based self management of advanced COPD.
A total of thirty patients will be enrolled into this study. Twenty patients will be randomly assigned to receive usual care, and ten patients will be randomly assigned to usual care plus in home support services. This study will use objective criteria to identify patients with COPD likely to benefit from home based palliative care services. The patients will undergo initial assessment by medical, social work, and spiritual care personnel followed by a family meeting to establish a care plan. Periodic scheduled visits, and as needed unscheduled visits to address urgent needs will occur over one year's time in an attempt to return patients with COPD to the center of decision making regarding their care, avoid acute exacerbations and thereby avoid unscheduled clinic and ER visits. Patients will complete the QOL survey and symptom assessment scale upon initial intervention. After obtaining information from all patients who qualify for the study, participants will be randomized into cohorts. Those who are randomized to serve as cases will be provided with community based self management services by an interdisciplinary palliative care team. The control group will receive standard care. At the conclusion of 12 months both cases and controls will again complete the QOL survey,medical utilization, and symptom assessment.
- Conditions
- Pulmonary Disease Chronic Obstructive
- Being tested
- Palliative home care in advanced COPD, Standard of care
- Keywords
- Community based self management of COPD with palliative care
- 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.
Palliative home care in advanced COPDOther
Interdisciplinary palliative care team on community based self care management of advanced COPD.
Standard of careOther
Usual care for COPD patients
| Study group | Role | What they receive |
|---|---|---|
| Home-based palliative care services | Patients who are 60 or more years of age and have a diagnosis of COPD.Patients who have received two or more unscheduled acute care visits during the 12 months prior to the start of the study. Receives: Other: Palliative home care in advanced COPD | |
| Standard of care | Patients who are 60 or more years of age and have a diagnosis of COPD.Patients who have received two or more unscheduled acute care visits during the 12 months prior to the start of the study. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health service utilization, symptom scores, and patient quality of life
Health care utilization: over 12 months while enrolled on study vs. 12 months prior to enrollment. For symptom scores and quality of life: at the time of enrollment and at the end of 12 months study period.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease Chronic ObstructiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medica Sur Clinic & Foundation
- Investigators
- Dean Fox, MD, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648609
- Sponsor's protocol ID
- 080801
- Status last verified
- Jun 2011
- First submitted
- 27 Mar 2008
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Curtis JR, Engelberg RA, Wenrich MD, Au DH. Communication about palliative care for patients with chronic obstructive pulmonary disease. J Palliat Care. 2005 Autumn;21(3):157-64.
PubMed 16334970Halpern MT, Stanford RH, Borker R. The burden of COPD in the U.S.A.: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S81-9. doi: 10.1016/s0954-6111(03)80028-8.
PubMed 12647946Rocker GM, Sinuff T, Horton R, Hernandez P. Advanced chronic obstructive pulmonary disease: innovative approaches to palliation. J Palliat Med. 2007 Jun;10(3):783-97. doi: 10.1089/jpm.2007.9951.
PubMed 17592991American Academy of Hospice and Palliative Medicine; Center to Advance Palliative Care; Hospice and Palliative Nurses Association; Last Acts Partnership; National Hospice and Palliative Care Organization. National Consensus Project for Quality Palliative Care: Clinical Practice Guidelines for quality palliative care, executive summary. J Palliat Med. 2004 Oct;7(5):611-27. doi: 10.1089/jpm.2004.7.611. No abstract available.
PubMed 15588352Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592.
PubMed 8887592
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Self Management of COPD Facilitated by a Palliative Care Team:Impact on Health Care Utilization and QOL
- ClinicalTrials.gov ID
- NCT00648609
- Acronym / sponsor ID
- 080801
- Conditions
- Pulmonary Disease Chronic Obstructive
- Keywords
- Community based self management of COPD with palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Collaborators
- Medica Sur Clinic & Foundation
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Apr 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.
The purpose of this study is to compare in home support services for patients with COPD with usual care. The study is designed to evaluate the impact of an interdisciplinary palliative care team on community based self management of advanced COPD.
A total of thirty patients will be enrolled into this study. Twenty patients will be randomly assigned to receive usual care, and ten patients will be randomly assigned to usual care plus in home support services. This study will use objective criteria to identify patients with COPD likely to benefit from home based palliative care services. The patients will undergo initial assessment by medical, social work, and spiritual care personnel followed by a family meeting to establish a care plan. Periodic scheduled visits, and as needed unscheduled visits to address urgent needs will occur over one year's time in an attempt to return patients with COPD to the center of decision making regarding their care, avoid acute exacerbations and thereby avoid unscheduled clinic and ER visits. Patients will complete the QOL survey and symptom assessment scale upon initial intervention. After obtaining information from all patients who qualify for the study, participants will be randomized into cohorts. Those who are randomized to serve as cases will be provided with community based self management services by an interdisciplinary palliative care team. The control group will receive standard care. At the conclusion of 12 months both cases and controls will again complete the QOL survey,medical utilization, and symptom assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based palliative care services | – | Other: Palliative home care in advanced COPDPatients who are 60 or more years of age and have a diagnosis of COPD.Patients who have received two or more unscheduled acute care visits during the 12 months prior to the start of the study. |
| Standard of care | – | Other: Standard of carePatients who are 60 or more years of age and have a diagnosis of COPD.Patients who have received two or more unscheduled acute care visits during the 12 months prior to the start of the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced COPD from St. Mary's Duluth Clinic Health Systrem population in Duluth Minnesota
Key inclusion criteria (6 listed)
- Age 60 or greater
- Dx of COPD
- Received 2 or more unscheduled acute care visits during the 12 months from Jan 2007-Dec 2007
- SMDC primary care provider
- Lives within 50 miles of Duluth Minnesota
Key exclusion criteria (4 listed)
- Non English speaking
- Too ill or cognitively impaired to provide baseline data or informed consent
- Lives more than 50 miles from Duluth
- Nursing home resident
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 |
|---|---|---|
| Palliative home care in advanced COPDInterdisciplinary palliative care team on community based self care management of advanced COPD. | Other | Home-based palliative care services |
| Standard of careUsual care for COPD patients | Other | Standard of care |
Primary outcome
Health service utilization, symptom scores, and patient quality of life
Time frame: Baseline and 12 months
Health care utilization: over 12 months while enrolled on study vs. 12 months prior to enrollment. For symptom scores and quality of life: at the time of enrollment and at the end of 12 months study period.
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 20 Jun 2011.
- Background: PubMed 16334970Curtis JR, Engelberg RA, Wenrich MD, Au DH. Communication about palliative care for patients with chronic obstructive pulmonary disease. J Palliat Care. 2005 Autumn;21(3):157-64.
- Background: PubMed 12647946Halpern MT, Stanford RH, Borker R. The burden of COPD in the U.S.A.: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S81-9. doi: 10.1016/s0954-6111(03)80028-8.
- Background: PubMed 17592991Rocker GM, Sinuff T, Horton R, Hernandez P. Advanced chronic obstructive pulmonary disease: innovative approaches to palliation. J Palliat Med. 2007 Jun;10(3):783-97. doi: 10.1089/jpm.2007.9951.
- Background: PubMed 15588352American Academy of Hospice and Palliative Medicine; Center to Advance Palliative Care; Hospice and Palliative Nurses Association; Last Acts Partnership; National Hospice and Palliative Care Organization. National Consensus Project for Quality Palliative Care: Clinical Practice Guidelines for quality palliative care, executive summary. J Palliat Med. 2004 Oct;7(5):611-27. doi: 10.1089/jpm.2004.7.611. No abstract available.
- Background: PubMed 8887592Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592.
Related trials for Pulmonary Disease Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Dean Fox, MD principal investigator
Essentia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease Chronic Obstructive, run by Essentia Health at 1 site in United States.
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 6 inclusion and 4 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 20 Jun 2011. 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 United States. 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?
Health service utilization, symptom scores, and patient quality of life (time frame: Baseline and 12 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 NCT00648609, which also lists 5 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 20 Jun 2011.