Home-Based Health Management of COPD Patients
2 other identifiers
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Sep 2016
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
February 24, 2021
CompletedFebruary 24, 2021
February 1, 2021
2.5 years
March 3, 2015
November 17, 2020
February 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Steps measured at baseline (week 1) and week 9
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.
Quality of Life measured at baseline (week 1) and week 9
Study Arms (2)
Activity Monitor plus Health Coaching
EXPERIMENTALDevice: 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.
Control
NO INTERVENTIONDevice: 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.
Interventions
Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- high likelihood of being lost to follow-up or contact
- inability to provide good data or follow commands
- inability to do mild exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara Seifertlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Mayo Cliniccollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
PMID: 33906954DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johanna Hoult
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Seifert, MPH
Minnesota HealthSolutions
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
March 3, 2015
First Posted
September 23, 2015
Study Start
September 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
February 24, 2021
Results First Posted
February 24, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share