Clinical trial NCT02275078: Innovations in Treating COPD Exacerbations: Pilot Project on Action Plans Using New Technology.
Official title: Pilot Study Evaluating the Feasibility and Potential Benefits of a Novel Approach of COPD Self-management That Includes a Phone Assessment/Reporting System (Tele-system)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Action Plan
Telesystem
New technology
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2014-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this project is to conduct a pilot study evaluating the feasibility and potential benefits of a phone assessment/reporting system (tele-system) in addition to a written action plan and nurse case manager support to improve patients' adherence to COPD treatment in those at risk for exacerbations.

Primary objective: explore the potential benefits with respect to patient's adherence, i.e., prompt use of the antibiotic and/or prednisone in the event of an exacerbation, increased adherence to maintenance medication; to increase patient's self-efficacy" in self-managing their disease; and to use more efficiently program resources, i.e., the case-manager.

Secondary objectives:

To assess the proportion of patients who effectively self manage exacerbations by using their COPD Action Plan

To assess self management of COPD patients with respect to the increased adherence to regular respiratory medication, (SmartInhaler electronic monitoring);

To assess increased self-efficacy in COPD patients identifying and managing exacerbations (baseline vs after 12 months);

To assess symptoms recovery, health status improvement, and prevention of ER visits and hospital admissions for COPD exacerbations.

To assess the efficiency in using program resources,

To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;

To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;

To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).

Detailed description: BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of death in Canada and the only chronic disease where mortality rates continue to climb. Acute exacerbations are common.Unfortunately, exacerbations are often viewed as trivial events or "simple bronchitis"despite being linked with accelerated lung function decline, poor health, hospital admissions and premature death.Conversely, prompt treatment reduces recovery time,improves health status, and decrease hospital admissions.In most patients, exacerbations are managed either in primary care walk-in clinics or emergency departments (ED), resulting in suboptimal management and high utilization costs.Furthermore, less severe exacerbations (\~60%) remain unreported and untreated, although these likely have a significant negative impact on health. In Canada, quality indicators suggest that chronic disease management remains suboptimal, especially in COPD.

RATIONALE: In COPD clinics, the investigators group and others have shown that patients who learn how to self-monitor and manage acute exacerbations by following a COPD Action Plan have better health outcomes and lower rates of health care utilization (unplanned office visits, ED use, and hospital admissions). Key elements of effective self-management programs include a written Action Plan, standing orders for exacerbation medications (antibiotics/prednisone), and self-management skills training combined with access to nurse case manager support. However, these programs are time and resource intensive and hence very challenging to implement across practices, especially in those that are not specialized. Recent advances in patient-provider communication technology, such as interactive phone systems, show promise in helping inform and motivate patients with asthma, diabetes and hypertension to effectively self monitor symptoms and better self-manage their diseases.Communication technology offers new opportunities to develop chronic disease self-management programs that can be easily implemented and less likely to place additional burden on busy practices.

Eligibility criteria: Inclusion Criteria:

* Patients will be adults with COPD at high risk for exacerbations
* Post bronchodilator spirometry FEV1 \<80% pred. and FEV1/FVC \<0.70
* Aged ≥ 40 yrs
* Smoking ≥ 10 pack-years
* 1 or more exacerbations requiring antibiotic or prednisone in the last year. (This is the population with the highest chance of having another exacerbation
* Combination therapy LABA-ICS (Advair) with or without an anticholinergic (Spiriva or Atrovent) and a rescue SABA (Ventolin)

Exclusion Criteria:

* Combination therapy LABA-ICS other than Advair
* Home oxygen for 18-24 hours/day
* Chronic CO2 retention
* Previous NIMV/MV
* Cognitive impairment
* Does not speak English or French fluently
* Severe co-morbidities such as bronchiectasis with recurrent infections, severe left congestive heart failure
* Survival \<6 months
* Any significant medical condition other than COPD that may also result in dyspnea (e.g. unstable angina, BMI \> 40).

Primary outcomes:
measure: - Patient adherence to action plan
timeFrame: within 3 days.
Secondary outcomes:
measure: Respiratory medication adherence
timeFrame: 12 months
measure: Self-efficacy to manage exacerbations:
timeFrame: 12 months
measure: Health care utilization
timeFrame: 12 months
measure: Phone System
timeFrame: 12 months
Other outcomes:
measure: Process and Implementation Evaluation
timeFrame: end of study at 12 months
measure: Covariates- Sociodemographic and clinical data
timeFrame: 12 months
measure: Comorbidities:
timeFrame: 12 months
measure: Baseline respiratory status. Dyspnea will be evaluated using a 5-grade Medical Research Council (MRC) dyspnea scale.
timeFrame: 12 months
measure: Spirometry will be done according to stringent standards. Disease severity is categorized according to the GOLD classification. Measures will be obtained at baseline and end of treatment by the research coordinator.
timeFrame: 12 months
measure: Anxiety and Depression.
timeFrame: 12 months
Locations:
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Jean Bourbeau, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farias R, Sedeno M, Beaucage D, Drouin I, Ouellet I, Joubert A, Abimaroun R, Patel M, Abou Rjeili M, Bourbeau J. Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD Action Plan adherence. BMJ Open Respir Res. 2019 Apr 9;6(1):e000379. doi: 10.1136/bmjresp-2018-000379. eCollection 2019.