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Home-Based Health Management of COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
health coaching
Sponsored by
Sara Seifert
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of GOLD stage II, III, or IV COPD
  • current or previous smoker with at least 10 pack-years of cigarette smoking
  • be hospitalized for an exacerbation of COPD

Exclusion Criteria:

  • high likelihood of being lost to follow-up or contact
  • inability to provide good data or follow commands
  • inability to do mild exercise

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Activity Monitor plus Health Coaching

Control

Arm Description

Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.

Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.

Outcomes

Primary Outcome Measures

Change in Number of Daily Steps Between the Intervention and Control Conditions
Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease.
Change in Physical Quality of Life Between the Intervention and Control Conditions
Measure Description: The Chronic Respiratory Disease Questionnaire measures physical and emotional aspects with 20 items in four domains/categories. The two domains/categories used for physical summary were dyspnea and fatigue. The items are assessed numerically on a 7-point modified Likert scale (from 1 to 7). Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. Physical quality of life is obtained by adding the fatigue and dyspnea scores and dividing by two; hence, the score range is from 1 to 7. Higher scores indicate better health-related quality of life. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2015
Last Updated
February 10, 2021
Sponsor
Sara Seifert
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02557178
Brief Title
Home-Based Health Management of COPD Patients
Official Title
Home-Based Health Management of COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Seifert
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Activity Monitor plus Health Coaching
Arm Type
Experimental
Arm Description
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
Intervention Type
Behavioral
Intervention Name(s)
health coaching
Intervention Description
Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
Primary Outcome Measure Information:
Title
Change in Number of Daily Steps Between the Intervention and Control Conditions
Description
Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease.
Time Frame
Steps measured at baseline (week 1) and week 9
Title
Change in Physical Quality of Life Between the Intervention and Control Conditions
Description
Measure Description: The Chronic Respiratory Disease Questionnaire measures physical and emotional aspects with 20 items in four domains/categories. The two domains/categories used for physical summary were dyspnea and fatigue. The items are assessed numerically on a 7-point modified Likert scale (from 1 to 7). Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. Physical quality of life is obtained by adding the fatigue and dyspnea scores and dividing by two; hence, the score range is from 1 to 7. Higher scores indicate better health-related quality of life. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.
Time Frame
Quality of Life measured at baseline (week 1) and week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of GOLD stage II, III, or IV COPD current or previous smoker with at least 10 pack-years of cigarette smoking be hospitalized for an exacerbation of COPD Exclusion Criteria: high likelihood of being lost to follow-up or contact inability to provide good data or follow commands inability to do mild exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Seifert, MPH
Organizational Affiliation
Minnesota HealthSolutions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33906954
Citation
Benzo RP, Ridgeway J, Hoult JP, Novotny P, Thomas BE, Lam NM, V Benzo M, Kramer K, Seifert S. Feasibility of a Health Coaching and Home-Based Rehabilitation Intervention With Remote Monitoring for COPD. Respir Care. 2021 Jun;66(6):960-971. doi: 10.4187/respcare.08580. Epub 2021 Apr 27.
Results Reference
derived

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Home-Based Health Management of COPD Patients

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