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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Next Generation Technology for Chronic Care Self Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217710
• Other study ID #: 10-001171
• Secondary ID: 2R44AG029087-02A
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2010
• Last updated: May 11, 2015
• Start date: April 2012
• Est. completion date: January 2014

Study information

• Verified date: May 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Physical Activity
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of activity monitor/smartphone to accurately measure and record physical activity of COPD patients	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.	3 months	No
Secondary	Determine the feasibility of using the smartphone/activity monitoring technology for motivational interviewing based counseling .	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.	3 months	No
Secondary	Determine the effectiveness of smartphone/activity monitor plus the motivational interviewing based coaching to increase physical activity, improve quality of life or palliate symptoms .	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 .	3 months	No