NCT02999685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

September 29, 2016

Last Update Submit

January 3, 2020

Conditions

Chronic Obstructive Pulmonary DiseaseEmphysemaPulmonary Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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

    8 weeks from the start of the intervention

  • Daily Physical Activity measured by Actigraph

    To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers

    8 weeks from the start of the intervention

Study Arms (2)

Home-base Pulm Rehab w/ Health Coaching

ACTIVE COMPARATOR

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

Control/Wait

ACTIVE COMPARATOR

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

Interventions

Home-base Pulmonary Rehab with Health CoachingBEHAVIORAL
Control/WaitHome-base Pulm Rehab w/ Health Coaching

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (1)

  • 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.

    PMID: 29066590DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roberto Benzo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 29, 2016

First Posted

December 21, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)