Promoting Physical Activity in Chronic Obstructive Pulmonary Disease (COPD) Through New Technology and Health Coaching

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01217710
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : May 13, 2015
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:
The objective of this project is to validate the proposed smartphone-based activity monitor and to test its use for Motivational Interviewing based counseling for physical activity in Chronic Obstructive Pulmonary Disease (COPD).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Physical Activity Behavioral: Activity monitor/smartphone health coaching Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Next Generation Technology for Chronic Care Self Management
Study Start Date : April 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Behavioral: Activity monitor/smartphone health coaching
    Initial health coaching at enrollment will involve the collaborative creation of an action plan with personally relevant, specific actions for increasing physical activity. The short term goals will be rated for self-efficacy and modified to maximize likelihood of success. Health coaches will discuss important mediators of physical activity (e.g., self-efficacy, enjoyment, social support, problem-solving). Weekly coaching calls will involve discussion of progress toward goals and problem-solving of barriers utilizing a motivational interviewing approach. Motivational messages will also be developed and sent daily to participants via the smartphone. These messages will indicate the percentage of steps related to their daily goal.

Primary Outcome Measures :
  1. Validity of activity monitor/smartphone to accurately measure and record physical activity of COPD patients [ Time Frame: 3 months ]
    Conduct tests to evaluate the activity monitor/smartphone system's ability to capture physical activity for COPD patients in comparison with the gold standard device in the field. The average number of steps and minutes per day spent in physical activities recorded by the experimental device will be compared to the gold standard device.

Secondary Outcome Measures :
  1. Determine the feasibility of using the smartphone/activity monitoring technology for motivational interviewing based counseling . [ Time Frame: 3 months ]
    Investigators will test the usability of the smartphone diary for chronic disease self-management health coaching. Several measures of the usability of the diary will be collected.

  2. Determine the effectiveness of smartphone/activity monitor plus the motivational interviewing based coaching to increase physical activity, improve quality of life or palliate symptoms . [ Time Frame: 3 months ]
    Several measures will be collected,Physical Activity Level (total energy expenditure/resting metabolic rate), steps, quality of life, self efficacy and also a qualitative feedback .

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women age 40 years and older
  • Current or former smoker of at least 10 pack-years
  • Diagnosis of GOLD stage II to IV COPD as documented by pulmonary function testing (FEV1 (Forced expiratory volume in 1 second) <80 percent predicted, FEV1/FVC(Forced vital capacity)<0.71)
  • Able to walk independently or with a walking aid (e.g. wheeled walker, cane, standard walker)

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 living in the healthcare area.
  • Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01217710

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Aging (NIA)
Principal Investigator: Roberto P Benzo, M.D., MSc Mayo Clinic

Responsible Party: Roberto P. Benzo, Consultant Pulmonary and Critical Care Medicine, Mayo Clinic Identifier: NCT01217710     History of Changes
Other Study ID Numbers: 10-001171
2R44AG029087-02A1 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by Roberto P. Benzo, Mayo Clinic:
Chronic Obstructive Pulmonary Disease
Physical Activity
Self Management
Motivational Interviewing

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