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Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)

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ClinicalTrials.gov Identifier: NCT03865329
Recruitment Status : Completed
First Posted : March 6, 2019
Results First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Behavioral: Intervention- Home-based Pulmonary Rehabilitation Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations
Actual Study Start Date : January 20, 2018
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention- Home Pulmonary Rehabilitation
Participants will be offered a Home-based pulmonary rehabilitation program with health coaching.
 Behavioral: Intervention- Home-based Pulmonary Rehabilitation
Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Change in Chronic Respiratory Questionnaire (CRQ) Physical Symptoms Summary [ Time Frame: Baseline, 3 months ]
    The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Physical Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best.

  2. Change in Chronic Respiratory Questionnaire (CRQ) Emotional Symptoms Summary [ Time Frame: Baseline, 3 months ]
    The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.

  3. Daily Physical Activity [ Time Frame: 3 months ]
    Average number of steps per day recorded by ActiGraph activity monitor worn on the wrist for seven days at 3 months

  4. Change in the Self-Management Ability Scale (SMAS) Total Score [ Time Frame: Baseline, 3 months ]
    Measured using the total score from the self-reported SMAS 30 item questionnaire that measures ability and function. A higher score indicates more ability and function in everyday life. The SMAS30 has six areas, each with 5 questions. The minimum score is one and the max is 5. The mean is calculated for each section. A higher score indicates better self management.

  5. Change in Patient Health Questionnaire (PHQ-2) [ Time Frame: Baseline, 3 months ]
    Measured using the self-reported PHQ-2 consisting of a 2 item questionnaire inquiring about the frequency of depressed mood over the past 2 weeks on a scale of 0 to 3, 0=Not at all, 1=several days, 2=more than half the days, 3=nearly everyday. The minimum score is zero and the highest score is 6. A score greater than 3 may indicate depression.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865329


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Roberto P Benzo, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Roberto P. Benzo, Mayo Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] March 3, 2020

More Information
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Additional Information:

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Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03865329    
Other Study ID Numbers: 18-002453 (Pilot Study/R61)
R61HL142933 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2019    Key Record Dates
Results First Posted: August 10, 2020
Last Update Posted: August 10, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No