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Clinical Trials/NCT03865329
NCT03865329
Completed
N/A

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

Mayo Clinic1 site in 1 country9 target enrollmentJanuary 20, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
COPD Exacerbation
Sponsor
Mayo Clinic
Enrollment
9
Locations
1
Primary Endpoint
Adherence to One Balance Practice Routine
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause.

Detailed Description

Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective. In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation. 10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).

Registry
clinicaltrials.gov
Start Date
January 20, 2018
End Date
August 2, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roberto P. Benzo

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adherence to One Balance Practice Routine

Time Frame: Baseline to 3 months

Percentage of participants to adhere to one balance practice routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

Completion of the Daily Self-assessment

Time Frame: Baseline to 3 months

Percentage of participants to complete the daily self-assessment for 6 out of the 7 days for 12 weeks via the interactive home-based pulmonary rehabilitation program

Adherence to Two Balance Practice Routine

Time Frame: Baseline to 3 months

Percentage of participants to adhere to two balance practices routine per day for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

Adherence to Daily Flexible Practice Routine

Time Frame: Baseline to 3 months

Percentage of participants to adhere to the daily flexible practice routine for 6 out of the 7 days for 12 weeks prescribed via the interactive home-based pulmonary rehabilitation program

Secondary Outcomes

  • Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary(Baseline, 3 months)
  • Change in the Self-Management Ability Scale (SMAS) Total Score(Baseline, 3 months)
  • Change in Patient Health Questionnaire (PHQ-2)(Baseline, 3 months)
  • Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary(Baseline, 3 months)
  • Daily Physical Activity(3 months)

Study Sites (1)

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