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Multicomponent Intervention to Decrease Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations

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ClinicalTrials.gov Identifier: NCT01058486
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
HealthPartners Institute
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Self-Management and Motivational Interviewing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicomponent Intervention to Decrease COPD-related Hospitalizations
Study Start Date : September 2010
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Activity-Self Management Behavioral: Self-Management and Motivational Interviewing

Post hospital discharge, patients will be referred (<2 weeks) to pulmonary rehabilitation (PR) (1-2 sessions per week for 6-8 weeks). PR visits (approximately 1 hour) will include education, strengthening and endurance exercise as the patient tolerates.

A counselor (RN or RRT) and patient will meet once weekly after PR session. The counselor will assess the patient's self efficacy and knowledge of self-management principles of COPD. Based on the assessment and greatest needs identified by patient, the counselor will work with the participant to collaboratively develop a specific SM plan.Motivational interviewing techniques will be used.

Following completion of PR, the counselor will contact the patient monthly to provide clinical support on SM of COPD. To ensure consistency of intervention, we will use standardized treatment procedures and phone scripts.


No Intervention: Usual Care



Primary Outcome Measures :
  1. To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . [ Time Frame: 12 months ]
    "a priori" measure as funded by NIH

  2. To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. To determine the impact of the intervention on self efficacy for physical activity and disease management, physical activity level and active energy expenditure, and health-related quality of life [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058486


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Regions Hospital
St. Paul, Minnesota, United States, 55101
Sponsors and Collaborators
Mayo Clinic
HealthPartners Institute
Investigators
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Principal Investigator: Roberto P Benzo, M.D., MSc Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01058486     History of Changes
Other Study ID Numbers: 09-004341
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: March 2016
Keywords provided by Roberto P. Benzo, Mayo Clinic:
Chronic Disease Management
Physical Activity
Self-efficacy
Self management
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive