Home-Based Health Management of COPD Patients

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: health coaching

• Registration Number: NCT02557178
• Lead Sponsor: Sara Seifert

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2016-09
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Results First Submitted: 2020-11-17
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Results First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Activity Monitor plus Health Coaching	health coaching	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.

Primary Outcome Measures

Name	Time	Method
Change in Number of Daily Steps Between the Intervention and Control Conditions	Steps measured at baseline (week 1) and week 9	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	Quality of Life measured at baseline (week 1) and week 9	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States