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OpenTrials
Completed

NCT Number: NCT02557178

Home-Based Health Management of COPD Patients

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Coaching

Behavioral

Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.

Primary outcomes

  1. Change in Number of Daily Steps Between the Intervention and Control Conditions

    Time frame: 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.

  2. Change in Physical Quality of Life Between the Intervention and Control Conditions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sara Seifert

Industry

Collaborators

  • Mayo Clinic
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2015
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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