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

Not Applicable

Completed

• Conditions: Emphysema; Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation
• Interventions: Behavioral: Home-base Pulmonary Rehab with Health Coaching

• Registration Number: NCT02999685
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-21
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quality of Life: Chronic Respiratory Questionaire	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
Daily Physical Activity measured by Actigraph	8 weeks from the start of the intervention	To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States