Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial (CoNSPiRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02917915
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
McGill University
University of Toronto
Université de Sherbrooke
Information provided by (Responsible Party):
Michael Stickland, University of Alberta

Tracking Information
First Submitted Date  ICMJE September 23, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2021)
Physical activity assessed as steps per day as evaluated by Fitbit [ Time Frame: Change from baseline physical activity to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
Physical activity assessed as steps per day as evaluated by Fitbit and self-report [ Time Frame: Change from baseline physical activity to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2016)
  • Patient adherence to exacerbation action plan [ Time Frame: 6 months after rehabilitation has ended ]
  • Medication adherence assessed by pharmacy refill records [ Time Frame: 6 months after rehabilitation has ended ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 26, 2016)
  • Multidimensional Self-efficacy for Exercise Scale [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Self-efficacy for Walking Scale [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Self-efficacy for Medication Adherence [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • COPD Knowledge [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks), and 6 months post-rehabilitation ]
  • Psychological Need Satisfaction for Exercise Scale [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Psychological Need Thwarting Scale [ Time Frame: Change from the end of rehabilitation (6-8 weeks) to 6 months after rehabilitation ]
  • Treatment Self-regulation Questionnaire [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Functional exercise capacity assessed by the 6-minute walk test [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
  • Health-related quality of life assessed by the COPD Assessment Tool [ Time Frame: Change from baseline to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial
Official Title  ICMJE The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial
Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and comprehensive intervention for COPD patients that includes patient assessment, exercise training, and self-management education to promote behavior changes. PR has been shown to be the most effective strategy to improve clinical health outcomes, and is now considered to be a standard of care intervention for individuals with COPD who remain symptomatic despite optimal drug therapies. Despite considerable evidence supporting the effectiveness of PR at enhancing clinical outcomes, it is unclear if PR influences the behaviors that promote COPD management (i.e., physical activity, medication adherence, self-managing exacerbations).

In collaboration with the local clinical staff as well as national colleagues and the Canadian Thoracic Society, a new national pulmonary rehabilitation program has been co-developed that is designed to increase physical activity, medication adherence, and skills to help manage chronic lung diseases. The new program aims to increase people's confidence and autonomy for performing disease-management behaviors, and has been designed to be more effective at increasing physical activity, medication adherence, and disease management skills than previous pulmonary rehabilitation programs. The program is designed to be delivered within different settings of practice, including traditional PR centers, satellite sites (i.e., sites that are remote from the major institutions),with the use of Tele-health and web-based resources, and primary care medical centers. The effectiveness of the new Standardized Canadian PR program will be assessed relative to the traditional PR program. This trial is an important step towards establishing the necessary evidence that will then enable us to work on dissemination and implementation of this new standardized PR program across the country.

Detailed Description

Phase 1: The implementation of the new Canadian Standardized PR program "Real life project" will be done after evaluating the existing pulmonary rehabilitation program in each of the four sites (G.F. MacDonald Centre for Lung Health, Mount Sinai Hospital, Montreal Chest Institute and West Park Health Care Centre). This will serve as pilot testing of the new pulmonary rehabilitation program to identify problems, adapt solution and improve the program, its content and delivery.

Phase 2: A randomized parallel-controlled trial (RPCT) will also be implemented in one site at the G.F. MacDonald Centre for Lung Health. Entire PR classes will be block randomized according to a random numbers table to receive usual care (traditional PR) or the new Canadian Standardized PR program. Several rural Tele-health sites that participate in PR via the G.F. MacDonald Centre for Lung Health will also be included and randomized as well. Both groups will be exposed to the same exercise training component. The two groups will be exposed to different education components (described in detail elsewhere). The effectiveness of the new Canadian Standardized PR program (experimental group) will be evaluated relative to the Traditional PR program (active comparator group) in terms of clinical, behavioural, and psychological outcomes.

Primary Objective: To determine if the new Canadian Standardized PR program delivered in-person and in satellites sites with the support of Tele-health improves and maintains specific self-management behaviors after rehabilitation more than the traditional PR program.

Primary Outcome: Physical activity (in steps-per day as measured by Fitbit®) Secondary Outcomes: i) Medication adherence (measured by pharmacy refills); ii) exacerbation recognition and prompt decision-making (diary & phone calls).

Secondary Objectives: To determine if the new Canadian Standardized PR program improves predisposing factors of behavior change (knowledge, self-determination theory constructs such as motivation, and self-efficacy) following rehabilitation more than the Traditional PR program and if there is variation according to the method of delivering the program, i.e., via Tele-health technology vs in person.

To determine if the new Canadian Standardized PR program results in greater improvement of clinical outcomes (exercise capacity, health status) and health service use (hospital admissions) following completion of rehabilitation compared to the Traditional PR program.

Statistical Methods: Analysis for determining the potential benefit of the new Canadian Standardized PR program: Repeated measures ANOVAS will be conducted to evaluate changes over PR in behavioral outcomes (physical activity, medication adherence, exacerbation adherence), predisposing behavior change outcomes (self-efficacy, knowledge, self-determination theory constructs), and clinical outcomes (quality of life, exercise tolerance) between the Traditional PR group compared to the new Canadian Standardized PR group.

Patients' adherence to action plan and regular medication, self-efficacy, symptoms/health: After carefully examining data for distribution (and transforming if warranted), the investigators will first calculate the proportion (and 95% CI) of patients who initiate their action plan, including seeking treatment and increasing medications as appropriate within 48 hours of symptom onset. In the case of multiple exacerbations, only the first instance will be used. A separate analysis will be done for multiple exacerbations, to account for patient variables. The investigators will explore secondary objectives by evaluating changes over time in all patients in adherence to medication, self-efficacy, symptoms and, health related quality of life. Regression analyses will be used to explore changes in these outcomes while controlling for the effects of potential covariates and confounders such as baseline respiratory status, age, sex, disease severity, comorbidities and smoking status. The investigators will calculate means or proportions for acceptability to providers and resource use.

Sample Size Determination: The investigators anticipate a sample of 200 COPD patients (100 in each group), with 40 of those patients participating in rural sites by Tele-health. Sample size calculations are based on evaluating change in the primary outcome - physical activity as measured by steps per day - between the Traditional PR and new Canadian Standardized PR groups. A literature search indicated that Traditional PR seems to have a small to negligible effect on COPD patients' physical activity levels. Given that the new Canadian Standardized program is designed to specifically target predisposing factors of behavior change, the investigators anticipate a medium effect size increase in physical activity compared to the usual care program. In order to detect a medium effect size, with power = .80, and alpha = .05, the investigators will be recruiting 100 COPD patients per group (G*Power 3).

Data Handling and Record Keeping: Data will be collected and stored in a central Redcap database. Patients will all have a unique study code number, which will be the only unique identifier included within the Redcap database.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Other: Canadian Standardized PR
    Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the New Canadian Standardized PR educational approach (experimental).
  • Other: Traditional PR
    Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the Traditional PR education approach (active comparator).
Study Arms  ICMJE
  • Experimental: New Canadian Standardized PR
    • Education Content: exercise, living well with chronic lung disease, breathing management, conserving energy, pulmonary medications, inhaler devices, integrating exercise in your life, management of respiratory infections, management of aggravating environmental factors, management of stress & anxiety, nutrition, leisure & travel, getting a good night's sleep, enjoying intimacy, living in a smoke-free environment, integrating long-term oxygen into your life, keeping a healthy lifestyle.
    • Delivery style: During group sessions patients engage in active, participatory-based learning of program content. Workbooks are available. During one-on-one interactions motivational communication style (asking for permission before providing information, using open questions, etc.) is used.
    Intervention: Other: Canadian Standardized PR
  • Active Comparator: Traditional PR
    • Education Content: Exercise, anatomy, pulmonary diseases, healthier breathing, pulmonary medications, pulmonary devices, exercise action plan, allergies & pulmonary function tests, health and air quality, healthier eating, travel, stress management & relaxation, tips to remember/summary of content.
    • Delivery style: During group sessions, patients engage in passive learning of program content delivered in a lecture-style approach. Patients also receive one-on-one education regarding: dyspnea management/pacing, inhaler technique, exercise maintenance.
    Intervention: Other: Traditional PR
Publications * Selzler AM, Jourdain T, Wald J, Sedeno M, Janaudis-Ferreira T, Goldstein R, Bourbeau J, Stickland MK. Evaluation of an Enhanced Pulmonary Rehabilitation Program: A Randomised Controlled Trial. Ann Am Thorac Soc. 2021 May 18. doi: 10.1513/AnnalsATS.202009-1160OC. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 14, 2021)
207
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2016)
200
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must be enrolled into pulmonary rehabilitation within our affiliated PR sites, or in satellite Tele-health program, with a diagnosis of COPD confirmed by post-bronchodilator forced expiratory volume in 1 second by forced vital capacity (FEV1/FVC) ratio of less than 0.7.
  • Patients must be able to read and communicate in English or French.

Exclusion Criteria:

  • Patients enrolled into pulmonary rehabilitation with a diagnosis other than COPD will be excluded.
  • Patients with cognitive impairments who are unable to accurately complete questionnaires will also be excluded.
  • As part of standard rehabilitation referral procedures, all patients must be ambulatory and not have unstable cardiovascular disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02917915
Other Study ID Numbers  ICMJE Pro00066560
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Stickland, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • McGill University
  • University of Toronto
  • Université de Sherbrooke
Investigators  ICMJE
Principal Investigator: Michael K Stickland, PhD University of Alberta
PRS Account University of Alberta
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP