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Clinical Trials/NCT01217710
NCT01217710CompletedPhase 2

Next Generation Technology for Chronic Care Self Management

Mayo Clinic1 site in 1 country38 target enrollmentStarted: April 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
38
Locations
1
Primary Endpoint
Validity of activity monitor/smartphone to accurately measure and record physical activity of COPD patients

Study 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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Roberto P. Benzo

Consultant Pulmonary and Critical Care Medicine

Mayo Clinic

Study Sites (1)

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