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Clinical Trials/NCT01217710
NCT01217710
Completed
Phase 2

Next Generation Technology for Chronic Care Self Management

Mayo Clinic1 site in 1 country38 target enrollmentApril 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Mayo Clinic
Enrollment
38
Locations
1
Primary Endpoint
Validity of activity monitor/smartphone to accurately measure and record physical activity of COPD patients
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
January 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roberto P. Benzo

Consultant Pulmonary and Critical Care Medicine

Mayo Clinic

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).

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Study Sites (1)

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