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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Self-Management and Motivational Interviewing

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Disease Management, Physical Activity, Self-efficacy, Self management

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Mayo Clinic
Regions Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Activity-Self Management

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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

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.

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

Full Information

NCT ID

NCT01058486

First Posted

January 22, 2010

Last Updated

September 28, 2016

Sponsor

Mayo Clinic

Collaborators

HealthPartners Institute

1. Study Identification

Unique Protocol Identification Number

NCT01058486

Brief Title

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

Official Title

Multicomponent Intervention to Decrease COPD-related Hospitalizations

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

HealthPartners Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

215 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Activity-Self Management

Arm Type

Experimental

Arm Title

Usual Care

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Self-Management and Motivational Interviewing

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 .

Description

"a priori" measure as funded by NIH

Time Frame

12 months

Title

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roberto P Benzo, M.D., MSc

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55902

Country

United States

Facility Name

Regions Hospital

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30914491

Citation

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.

Results Reference

derived

PubMed Identifier

26953637

Citation

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.

Results Reference

derived

PubMed Identifier

25511306

Citation

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.

Results Reference

derived

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

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