Multicomponent Intervention to Decrease Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2010 |
| End Date: | July 2016 |
| Contact: | Roberto P Benzo, M.D., MSc |
| Email: | benzo.roberto@mayo.edu |
| Phone: | 507-284-3764 |
Multicomponent Intervention to Decrease COPD-related Hospitalizations
The investigators' proposed study is a randomized controlled trial that will prospectively
examine the effect of a multicomponent intervention on the rate of hospitalizations, daily
physical activity, self efficacy and health status in patients who have COPD and have been
hospitalized because of a COPD exacerbation.
In the study, a convenience sample of patients recently hospitalized for a COPD
exacerbation, who meet the selection criteria and agree to participate will be randomized to
receive one of the following at the time of hospital discharge: (1) the current standard of
care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the
current standard of care without the intervention.
This study plans to test the following hypotheses: (1) The primary outcome of the study to
be the composite endpoint of death or COPD hospitalization (2) Time to first
rehospitalization will be shorter in the intervention group than the control group (3) At
follow-up, the physical activity level measured in terms of the average number of steps and
active energy expenditure will be higher in the intervention group than in the control
group.
examine the effect of a multicomponent intervention on the rate of hospitalizations, daily
physical activity, self efficacy and health status in patients who have COPD and have been
hospitalized because of a COPD exacerbation.
In the study, a convenience sample of patients recently hospitalized for a COPD
exacerbation, who meet the selection criteria and agree to participate will be randomized to
receive one of the following at the time of hospital discharge: (1) the current standard of
care plus a multicomponent intervention (counselor + pulmonary rehabilitation) or (2) the
current standard of care without the intervention.
This study plans to test the following hypotheses: (1) The primary outcome of the study to
be the composite endpoint of death or COPD hospitalization (2) Time to first
rehospitalization will be shorter in the intervention group than the control group (3) At
follow-up, the physical activity level measured in terms of the average number of steps and
active energy expenditure will be higher in the intervention group than in the control
group.
Inclusion Criteria:
- Patients must be ≥40 years old
- Clinical diagnosis of COPD or pulmonary function testing reflecting an FEV1/FVC ratio
of <0.70
- Current or previous smoker with at least 10 pack-years of cigarette smoking
- Recently hospitalized for an exacerbation of COPD
Exclusion Criteria:
- Patients with a high likelihood of being lost to follow-up or contact (patients with
active chemical dependency, are planning to move out of the state, are not living in
the healthcare area, or have no telephone at home).
- Patents with characteristics that can confound the analysis of the primary outcome
(patients who are living in a nursing home, have unresectable lung cancer, or have
another advanced neoplasm).
- Patients with an inability to provide good data or follow commands (patients who are
disoriented, have a severe neurologic or psychiatric condition).
- Patients with an inability to do mild exercise, such as cycling or walking, when
their COPD is stable (patients who have orthopedic-neurologic problems; patients who
have severe heart failure, characterized by an ejection fraction of <20% or by New
York Heart Association Class IV disease; patients who should be at complete rest,
confined to a bed or chair; or patients in whom any physical activity brings on
discomfort and in whom symptoms occur at rest).
We found this trial at
2
sites
Rochester, Minnesota 55905
Principal Investigator: Roberto P Benzo, M.D., MSc
Phone: 507-284-3764
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St. Paul, Minnesota 55101
Principal Investigator: Charlene M McEvoy, M.D., M.P.H.
Phone: 952-967-5485
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