Back to resultsPhysical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD) (PACC)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Physical Activity, Health Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephonic health coaching
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Motivational Interviewing, Health Coaching, Physical Activity
Eligibility Criteria
Inclusion Criteria:
- Men and women age 40 years and older
- Current or former cigarette smoker of at least 10 pack-years
- Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 <80% predicted, FEV1/FVC ration <0.71) within the past 24 months
- Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)
Exclusion Criteria:
- Unable to walk without assistance of another person
- 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 able to be contacted by telephone
- patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Health coaching
Arm Description
Outcomes
Primary Outcome Measures
Effectiveness of telephone-based health coaching in COPD.
Determine the effectiveness of a telephone-based health coaching intervention on daily physical activity level, as measured by a gold-standard activity monitor and daily pedometer record, acceptability of intervention through qualitative interviews with participants, and health-related quality of life as measured by questionnaires.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01349608
Brief Title
Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
PACC
Official Title
Physical Activity Coaching in COPD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active. Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking). The objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Physical Activity, Health Behavior
Keywords
Chronic Obstructive Pulmonary Disease, Motivational Interviewing, Health Coaching, Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health coaching
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Telephonic health coaching
Intervention Description
Participants will be given a pedometer and activity log to use daily to track their physical activity accomplishments. Weekly, they will participate in a health coaching telephone session to discuss physical activity and set goals. The health coach is knowledgable in COPD care and will utilize a motivational interviewing approach to support the self-efficacy of the participants to be more active.
Primary Outcome Measure Information:
Title
Effectiveness of telephone-based health coaching in COPD.
Description
Determine the effectiveness of a telephone-based health coaching intervention on daily physical activity level, as measured by a gold-standard activity monitor and daily pedometer record, acceptability of intervention through qualitative interviews with participants, and health-related quality of life as measured by questionnaires.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women age 40 years and older
Current or former cigarette smoker of at least 10 pack-years
Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 <80% predicted, FEV1/FVC ration <0.71) within the past 24 months
Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)
Exclusion Criteria:
Unable to walk without assistance of another person
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 able to be contacted by telephone
patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)
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
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)
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