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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Collaborator:
HealthPartners Institute for Education and Research
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01058486
First received: January 22, 2010
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Behavioral: Self-Management and Motivational Interviewing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicomponent Intervention to Decrease COPD-related Hospitalizations

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the time to the composite outcome, COPD related hospitalizations or death. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058486

Contacts
Contact: Roberto P Benzo, M.D., MSc 507-284-3764 benzo.roberto@mayo.edu
Contact: Johanna P Hoult 507-293-0190 hoult.johanna@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Roberto P Benzo, M.D., MSc    507-284-3764    benzo.roberto@mayo.edu   
Contact: Johanna P Hoult    507-293-0190    hoult.johanna@mayo.edu   
Principal Investigator: Roberto P Benzo, M.D., MSc         
Regions Hospital Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Charlene E McEvoy, M.D., M.P.H.    952-967-5485    charlene.e.mcevoy@healthpartners.com   
Contact: Linda M Loes, M.D.    952-967-7862    Linda.M.Loes@HealthPartners.Com   
Principal Investigator: Charlene M McEvoy, M.D., M.P.H.         
Sponsors and Collaborators
Mayo Clinic
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Roberto P Benzo, M.D., MSc Mayo Clinic
  More Information

No publications provided

Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01058486     History of Changes
Other Study ID Numbers: 09-004341
Study First Received: January 22, 2010
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Chronic Disease Management
Physical Activity
Self-efficacy
Self management

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014