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

NCT01217710 | Completed Phase 2

• 2 other identifiers: 10-0011712R44AG029087-02A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease; Physical Activity

Keywords

Chronic Obstructive Pulmonary Disease; Physical Activity; Self Management; Exercise; Technology; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Determine the feasibility of using the smartphone/activity monitoring technology for motivational interviewing based counseling .

  3 months

• Determine the effectiveness of smartphone/activity monitor plus the motivational interviewing based coaching to increase physical activity, improve quality of life or palliate symptoms .

  3 months

Interventions

Activity monitor/smartphone health coaching BEHAVIORAL

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 Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Roberto P Benzo, M.D., MSc

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: April 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

US (1)