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COPD Access to Pulmonary Rehabilitation Intervention (CAPRI)

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ClinicalTrials.gov Identifier: NCT03794921
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Persons with COPD have significant functional disability but cannot access rehabilitative treatment at hospital-based conventional pulmonary rehabilitation (PR) programs. This project will determine whether an Internet-mediated, pedometer-based walking program can increase physical activity in persons with COPD who cannot access PR, compared to usual care. This proposal has high potential to deliver an immediate solution to a pressing clinical need. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.

Condition or disease Intervention/treatment Phase
COPD Other: Every Step Counts Not Applicable

Detailed Description:

Conventional pulmonary rehabilitation (PR) programs are highly effective and the standard of care in patients with chronic obstructive pulmonary disease (COPD). PR faces two significant problems: (1) most patients with COPD who would benefit from PR cannot access it, and 2) there is no effective long-term strategy to maintain physical activity (PA) and benefits after completing PR. The investigators propose a randomized controlled trial (RCT) to test the efficacy of a technology-mediated intervention to increase PA in persons with COPD who cannot access conventional, hospital-based PR. The investigators also propose a non-randomized study to explore the ability of the PA intervention to maintain PA and exercise adherence, extending the benefits of PR, in persons with COPD who complete a conventional PR program. COPD is the third leading cause of death in the United States; an estimated 16 million Americans have COPD. Despite maximal medical therapy, patients with COPD characteristically experience breathlessness, which leads to a downward spiral of sedentary behavior, physical inactivity, deconditioning, and functional disability. Low physical activity is associated with poor outcomes in COPD--increased risk of acute exacerbations, hospitalizations, and death, independent of lung function. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend regular PA for all patients with COPD. Conventional, supervised PR programs clearly reduce breathlessness, and improve health-related quality of life (HRQL) and exercise capacity. However, PR programs face significant challenges of access and adherence. The investigators developed Every Step Counts (ESC), a technology-mediated intervention based on the Behavioral Theory of Self-Regulation, to target sedentary behavior, promote PA, and alleviate deconditioning. ESC couples a website with a pedometer to directly monitor step counts. The website provides individualized step-count goals, iterative feedback, education on disease self-management, motivation, and an online community of social support. In two randomized studies in Veterans with COPD, the investigators demonstrated ESC's safety, feasibility, and efficacy to increase PA. Accessible via the internet and available at any time from home, ESC could be an ideal low-cost platform to address the limitations of conventional PR. The investigators hypothesize that ESC may be an efficacious strategy to promote PA in the many patients who cannot attend a PR program, and may be an option to maintain engagement in PA after patients complete a conventional PR program.

Primary Aim 1: Determine the efficacy of a web-based intervention, ESC, to increase PA (measured directly with an accelerometer and a questionnaire that assesses intensity), compared to usual care, in persons with COPD who are referred to conventional PR but who cannot access it.

Secondary Aim 2: Estimate the effect of the ESC intervention on (a) exercise adherence, (b) exercise self-efficacy, (c) HRQL, (d) dyspnea, (e) anxiety and depression, (f) exercise capacity, and (g) risk of acute exacerbations and COPD-related hospitalizations, compared to usual care.

Exploratory Aim 3: Assess the ability of ESC to maintain PA and exercise adherence, and extend the benefits of PR, in participants with COPD who have completed conventional PR.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: As the primary aim, the investigators propose a RCT to study the efficacy of a web-based, pedometer-mediated physical activity intervention to increase physical activity in persons with COPD who decline conventional pulmonary rehabilitation, compared to usual care. The investigators anticipate that 120 subjects will be randomized 1:1 to either the intervention or usual care.
Masking: Single (Outcomes Assessor)
Masking Description: Study staff communicating randomization assignments to subjects will be different from study staff conducting follow-up outcome assessments.
Primary Purpose: Treatment
Official Title: Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans With COPD
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : April 3, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Usual Care
Using a standardized script at the randomization phone call, study staff will deliver verbal instructions to slowly and steadily increase one's walking and exercise each week. Participants will be asked to perform exercise of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover. Use of the Borg rating scale for dyspnea will be reviewed with each participant. Exercise is defined as planned PA, outside of activities performed as part of one's daily routine. Exercise can be walking in the community or using exercise equipment at a local gym. Adapted written materials reinforce the verbal instructions. Participants will receive this 45-page spiral-bound book with information about aerobic and strength training exercises.
Experimental: Every Step Counts Intervention
After randomization to ESC, participants will be mailed detailed instructions about the website. They will be asked to wear the lightweight, unobtrusive pedometer every day, except while asleep or showering/bathing, during the 12-week intervention period. Subjects will be instructed to upload their date and time-stamped step-count data to the study website as often as they wish, but at least weekly. Each week, the study computer will run the goal calculation algorithm and provide each participant with his/her daily step-count goal for the week. The week's step-count goal will be prominently displayed on each subject's personal study web page. Participants will be instructed to exercise and reach their individualized step-count goals with walking of moderate intensity for at least 30 minutes on most days of the week, defined as a dyspnea level of 4-5 on the Borg scale and taking 1-2 minutes to recover.
Other: Every Step Counts
Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support.




Primary Outcome Measures :
  1. Physical Activity measured as Daily Step Count [ Time Frame: 12 weeks ]
    Daily Step Count directly measured with a monitoring device.


Secondary Outcome Measures :
  1. Exercise Adherence [ Time Frame: 12 weeks ]
    Patient self-report using daily logs.

  2. Exercise Self-Regulatory Efficacy [ Time Frame: 12 weeks ]
    Assessed by the Exercise Self-Regulatory Efficacy Scale questionnaire. 16-item questionnaire. Participants indicate their confidence level from 0% (not at all confident) to 100% (highly confident).

  3. Health-Related Quality of Life using a disease specific questionnaire [ Time Frame: 12 weeks ]
    Assessed by the St. George's Respiratory Questionnaire. The investigators will use the Total Score and the 3 Domains of Activity, Symptoms, and Impacts. Scores range from 0 to 100, with lower scores representing better health related quality of life.

  4. Shortness of Breath rating as perceived by the participant [ Time Frame: 12 weeks ]
    Shortness of Breath is one outcome measured in 2 ways. It will be assessed by the University of California, San Diego (UCSD) Shortness of Breath (SOB) Questionnaire and the modified Medical Research Council scale. The UCSD SOB Questionnaire contains 24 items with scores ranging from 0 to 120. The modified Medical Research Council (mMRC) dyspnea scale ranges from 0 to 4, with higher numbers representing more shortness of breath.

  5. Level of Anxiety experienced by the participant [ Time Frame: 12 weeks ]
    Assessed by the Generalized Anxiety Disorder 7-item scale (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.

  6. Exercise Capacity [ Time Frame: 12 weeks ]
    6-minute walk test distance measured in meters.

  7. Healthcare Utilization represented by number of Acute Exacerbations and Hospitalizations over timeframe [ Time Frame: 12 weeks and 6 months ]
    Acute Exacerbation and Hospitalization History. Assessment of total number of acute exacerbations (AEs) and hospitalizations over the timeframe of 12 weeks and 6 months is based on both self-report and medical chart review.

  8. Amount of Depression experienced by the participant [ Time Frame: 12 weeks ]
    Depression measured by the Beck's Depression Inventory-II questionnaire. 21-items. Scores range with 0 to 63 with higher scores representing greater severity of depression.


Other Outcome Measures:
  1. Brief Pain Inventory [ Time Frame: 12 weeks ]
    Pain Severity Score (8 items) is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.

  2. Health Utilities [ Time Frame: 12 weeks ]
    EuroQoL 5-Dimension Health Questionnaire (EQ-5D) Health Utilities. 2 pages assesses 5 dimensions with visual analog scale. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. The EQ VAS (EQ visual analogue scale) records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'.

  3. Number of participants who enroll in Conventional Pulm Rehab after participating in the research study [ Time Frame: 12 weeks and 6 months ]
    Numbers will be assessed by self-report and chart review.

  4. COPD Knowledge [ Time Frame: 12 weeks ]
    Bristol COPD Knowledge Questionnaire. 13-items that usually takes between 10 and 20 minutes to complete. Percent of questions scored correctly is assessed and range from 0 to 100 %..

  5. Sleepiness [ Time Frame: 12 weeks ]

    Epworth Sleepiness Scale. 8 questions, each on a scale of 0-3. Minimum score is 0 and maximum score is 24.

    0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness


  6. Social Support [ Time Frame: 12 weeks ]
    MOS Social Support Survey. 18 items with scores ranging from 0 to 100, with higher scores representing greater social support.

  7. Lung Function [ Time Frame: 12 weeks ]
    Spirometry assessment of forced expiratory volume in 1 second (FEV1)

  8. Concentration of C-reactive protein [ Time Frame: 12 weeks ]
    Blood protein marker of systemic inflammation. Blood draw for C-reactive protein (CRP) with units of mg/L

  9. Concentration of Interleukin-6 [ Time Frame: 12 weeks ]
    Blood protein marker of systemic inflammation. Blood draw for Interleukin-6 (IL-6) with units of ng/mL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Male and female subjects, greater than or equal to 40 years of age
  • Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity (FVC) < 0.70 or chest CT evidence of emphysema or prior documentation of FEV1/FVC ratio of < 0.7 and clinical evidence of COPD

    • defined as 10 pack-year cigarette smoking history
    • dyspnea
    • or on bronchodilators
  • Have declined participation in a conventional pulmonary rehabilitation program
  • Medical clearance from healthcare provider to participate in an exercise program
  • Have access to a computer with Internet connection, a USB port or Bluetooth capability, and Windows XP/Vista/7/8/10 or higher, or Mac OSX 10.5 or higher operating system, or willing to come to VA Medical Center to use study computers
  • Pedometer and accelerometer with >90% accuracy compared to manual counts on short clinic walk
  • Competent to provide informed consent
  • Willingness to make return visits and be available by telephone for duration of study

Exclusion Criteria:

  • COPD exacerbation in the previous 1 month
  • Inability to ambulate with or without assistance
  • Hypoxemia during six-minute walk test (6MWT)

    • i.e. oxygen saturation <85% using supplemental oxygen
  • Inability to complete questionnaires
  • Inability to collect at least 7 of 10 days of baseline step counts
  • Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
  • Participation in another exercise-related research study at time of screening
  • Plans to participate in an exercise-related research study in the next 3 months
  • Average baseline step counts of greater than or equal to 10,000 steps per week

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): NCT03794921


Contacts
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Contact: Marilyn L Moy, MD (857) 203-6622 Marilyn.Moy@va.gov
Contact: Eric Garshick, MD (857) 203-5536 Eric.Garshick@va.gov

Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Not yet recruiting
Boston, Massachusetts, United States, 02130
Contact: Marilyn L Moy, MD    857-203-6622    Marilyn.Moy@va.gov   
Contact: Eric Garshick, MD    (857) 203-5536    Eric.Garshick@va.gov   
Principal Investigator: Marilyn L. Moy, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Marilyn L. Moy, MD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03794921     History of Changes
Other Study ID Numbers: F2855-R
I01RX002855 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication.

  • A local privacy officer will certify that a dataset contains no Protected Health Information (PHI), Personally Identifiable Information (PII), or VA Sensitive Information prior to release outside VA.
  • Final data sets will be maintained locally on a secure server or comparable data storage appliance inside the VA network until enterprise-level resources become available for long-term storage and access.

The PI will create de-identified, study-specific datasets. Investigators requesting a copy of a dataset will sign a Letter of Agreement or a Data Use Agreement. A local privacy officer will certify that a dataset contains no PHI, PII, or VA Sensitive Information prior to release outside VA.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Pulmonary Rehabilitation
Technology-Mediated
Web-Based Intervention
Physical Activity