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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Physical Activity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Activity monitor/smartphone health coaching
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Physical Activity, Self Management, Exercise, Technology, Motivational Interviewing

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 .

Full Information

First Posted
October 6, 2010
Last Updated
May 11, 2015
Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01217710
Brief Title
Promoting Physical Activity in Chronic Obstructive Pulmonary Disease (COPD) Through New Technology and Health Coaching
Official Title
Next Generation Technology for Chronic Care Self Management
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Activity monitor/smartphone health coaching
Intervention Description
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 Measure Information:
Title
Validity of activity monitor/smartphone to accurately measure and record physical activity of COPD patients
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Determine the feasibility of using the smartphone/activity monitoring technology for motivational interviewing based counseling .
Description
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.
Time Frame
3 months
Title
Determine the effectiveness of smartphone/activity monitor plus the motivational interviewing based coaching to increase physical activity, improve quality of life or palliate symptoms .
Description
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 .
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 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).
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

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

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