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

NCT01058486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2016-09-30

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

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.

Sponsors & Collaborators

  • HealthPartners Institute

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Roberto P Benzo, M.D., MSc · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01058486 on ClinicalTrials.gov