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Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02999685
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Collaborator:
Minnesota HealthSolutions
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:
Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Emphysema Pulmonary Rehabilitation Behavioral: Home-base Pulmonary Rehab with Health Coaching

Detailed Description:
This study consists of a home-based pulmonary rehabilitation system. The system consists of a tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls. The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A will complete the study activities during the first 8 weeks of the study followed by a period of observation. Group B will complete 8 weeks of observation followed by 8 weeks of rehabilitation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home-based Health Management of COPD Patients
Study Start Date : September 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Home-base Pulm Rehab w/ Health Coaching
The intervention group starts with 8 weeks of Home-base Pulmonary Rehab with Health Coaching, followed by 8 weeks of observation.
Behavioral: Home-base Pulmonary Rehab with Health Coaching
Active Comparator: Control/Wait
The Control/Wait group starts with 8 weeks of observation, followed by 8 weeks of intervention (Home-base Pulm Rehab w/ Health Coaching).
Behavioral: Home-base Pulmonary Rehab with Health Coaching



Primary Outcome Measures :
  1. Quality of Life: Chronic Respiratory Questionaire [ Time Frame: 8 weeks from the start of the intervention ]
    To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional

  2. Daily Physical Activity measured by Actigraph [ Time Frame: 8 weeks from the start of the intervention ]
    To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Men and women age 40 years and older

    • Current or former smoker of at least 10 pack-years
    • Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or IV COPD as documented by pulmonary function
    • Are eligible for Pulmonary Rehabilitation

Exclusion Criteria:

  • • Unable to perform mild exercises

    • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999685


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
Minnesota HealthSolutions
Investigators
Principal Investigator: Roberto Benzo, MD Mayo Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberto P. Benzo, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02999685     History of Changes
Other Study ID Numbers: 14-009016
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Respiratory Tract Diseases
Pathologic Processes