Home-Based Health Management of COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Home-Based Health Management of COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557178
• Other study ID #: R44HL114162-02A1
• Secondary ID: R44HL114162
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: February 2021
• Source: Minnesota HealthSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• health coaching
Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Sara Seifert	Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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