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Completed

NCT Number: NCT03865329

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

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.

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Key information

Conditions

COPD Exacerbation

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Intervention- Home-based Pulmonary Rehabilitation

Behavioral

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Aug 10, 2020

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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