Clinical trial NCT03865329: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)
Official title: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Exacerbation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-03-06
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria

* COPD related hospitalization and eligible for PR
* Age 40+
* Confidence (score \> 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

Exclusion Criteria

* Inability to walk (orthopedic-neurologic problems or confined to bed)

Primary outcomes:
measure: Adherence to One Balance Practice Routine
timeFrame: Baseline to 3 months
measure: Adherence to Two Balance Practice Routine
timeFrame: Baseline to 3 months
measure: Adherence to Daily Flexible Practice Routine
timeFrame: Baseline to 3 months
measure: Completion of the Daily Self-assessment
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary
timeFrame: Baseline, 3 months
measure: Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary
timeFrame: Baseline, 3 months
measure: Daily Physical Activity
timeFrame: 3 months
measure: Change in the Self-Management Ability Scale (SMAS) Total Score
timeFrame: Baseline, 3 months
measure: Change in Patient Health Questionnaire (PHQ-2)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References: