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

NCT01058486 | Completed DMC

• 1 other identifier: 09-004341
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Disease Management; Physical Activity; Self-efficacy; Self management

Outcome Measures

Primary Outcomes (2)

• 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 .

  "a priori" measure as funded by NIH

  12 months

• 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.

  12 months

Secondary Outcomes (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

  12 months

Study Arms (2)

Activity-Self Management

EXPERIMENTAL

Behavioral: Self-Management and Motivational Interviewing

Usual Care

NO INTERVENTION

Interventions

Self-Management and Motivational Interviewing BEHAVIORAL

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.

Activity-Self Management

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• HealthPartners Institute: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (3)

• Benzo R, McEvoy C. Effect of Health Coaching Delivered by a Respiratory Therapist or Nurse on Self-Management Abilities in Severe COPD: Analysis of a Large Randomized Study. Respir Care. 2019 Sep;64(9):1065-1072. doi: 10.4187/respcare.05927. Epub 2019 Mar 26.

  PMID: 30914491 DERIVED

• Benzo R, Vickers K, Novotny PJ, Tucker S, Hoult J, Neuenfeldt P, Connett J, Lorig K, McEvoy C. Health Coaching and Chronic Obstructive Pulmonary Disease Rehospitalization. A Randomized Study. Am J Respir Crit Care Med. 2016 Sep 15;194(6):672-80. doi: 10.1164/rccm.201512-2503OC.

  PMID: 26953637 DERIVED

• Benzo R, Wetzstein M, Neuenfeldt P, McEvoy C. Implementation of physical activity programs after COPD hospitalizations: Lessons from a randomized study. Chron Respir Dis. 2015 Feb;12(1):5-10. doi: 10.1177/1479972314562208. Epub 2014 Dec 15.

  PMID: 25511306 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Self-Management; Motivational Interviewing

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities

Study Officials

• Roberto P Benzo, M.D., MSc

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 28, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2016-03

Locations

US (2)