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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Emphysema, Pulmonary Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-base Pulmonary Rehab with Health Coaching
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 99 Years (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 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).

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Home-base Pulm Rehab w/ Health Coaching

Control/Wait

Arm Description

The intervention group starts with 8 weeks of Home-base Pulmonary Rehab with Health Coaching, followed by 8 weeks of observation.

The Control/Wait group starts with 8 weeks of observation, followed by 8 weeks of intervention (Home-base Pulm Rehab w/ Health Coaching).

Outcomes

Primary Outcome Measures

Quality of Life: Chronic Respiratory Questionaire
To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional
Daily Physical Activity measured by Actigraph
To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers

Secondary Outcome Measures

Full Information

First Posted
September 29, 2016
Last Updated
January 3, 2020
Sponsor
Mayo Clinic
Collaborators
Minnesota HealthSolutions
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1. Study Identification

Unique Protocol Identification Number
NCT02999685
Brief Title
Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients
Official Title
Home-based Health Management of COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Minnesota HealthSolutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Emphysema, Pulmonary Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-base Pulm Rehab w/ Health Coaching
Arm Type
Active Comparator
Arm Description
The intervention group starts with 8 weeks of Home-base Pulmonary Rehab with Health Coaching, followed by 8 weeks of observation.
Arm Title
Control/Wait
Arm Type
Active Comparator
Arm Description
The Control/Wait group starts with 8 weeks of observation, followed by 8 weeks of intervention (Home-base Pulm Rehab w/ Health Coaching).
Intervention Type
Behavioral
Intervention Name(s)
Home-base Pulmonary Rehab with Health Coaching
Primary Outcome Measure Information:
Title
Quality of Life: Chronic Respiratory Questionaire
Description
To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional
Time Frame
8 weeks from the start of the intervention
Title
Daily Physical Activity measured by Actigraph
Description
To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers
Time Frame
8 weeks from the start of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
99 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Benzo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29066590
Citation
Benzo RP, Kramer KM, Hoult JP, Anderson PM, Begue IM, Seifert SJ. Development and Feasibility of a Home Pulmonary Rehabilitation Program With Health Coaching. Respir Care. 2018 Feb;63(2):131-140. doi: 10.4187/respcare.05690. Epub 2017 Oct 24.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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