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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01217710
First received: October 6, 2010
Last updated: April 1, 2013
Last verified: March 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Next Generation Technology for Chronic Care Self Management

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Validity of activity monitor/smartphone to accurately measure and record physical activity of COPD patients [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Determine the feasibility of using the smartphone/activity monitoring technology for motivational interviewing based counseling . [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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 .


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217710

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Roberto P Benzo, M.D., MSc Mayo Clinic
  More Information

No publications provided

Responsible Party: Roberto P. Benzo, Consultant Pulmonary and Critical Care Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01217710     History of Changes
Other Study ID Numbers: 10-001171, 2R44 AG29087-02A1
Study First Received: October 6, 2010
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Chronic Obstructive Pulmonary Disease
Physical Activity
Self Management
Exercise
Technology
Motivational Interviewing

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

ClinicalTrials.gov processed this record on July 29, 2014