Innovations in Treating COPD Exacerbations: Pilot Project on Action Plans Using New Technology.

NCT02275078 | Completed DMC

• 1 other identifier: 12-053-BMD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD

Keywords

COPD; Action Plan; Telesystem; New technology

Outcome Measures

Primary Outcomes (1)

• - Patient adherence to action plan

  Proportion of patients who initiate use of COPD Action Plan including starting exacerbation medications (i.e., antibiotics and/or prednisone) within 3 days.

  within 3 days.

Secondary Outcomes (4)

• Respiratory medication adherence

  12 months

• Self-efficacy to manage exacerbations:

  12 months

• Health care utilization

  12 months

• Phone System

  12 months

Other Outcomes (6)

• Process and Implementation Evaluation

  end of study at 12 months

• Covariates- Sociodemographic and clinical data

  12 months

• Comorbidities:

  12 months

Study Arms (1)

Interventional

OTHER

The program consists of 3 components: 1) COPD self-management using an Action Plan; 2) Telesystem-Phone self-assessment/reporting system; and 3) Nurse case manager support.

Behavioral: COPD self-management using an action plan; Device: Telesystem-Phone self-assessment/reporting system; Other: Nurse case manager support

Interventions

COPD self-management using an action plan BEHAVIORAL

Behavioral: Self-management education on the use of a self-administered prescription for exacerbation. Patients will be instructed to start treatment within 48 hours of experiencing an acute exacerbation of COPD and/or after starting their self-administered prescription.

Interventional

Telesystem-Phone self-assessment/reporting system DEVICE

Phone Self-Assessment/Reporting System. The second component of the intervention is the use of a computer-linked interactive phone assessment/reporting system that can assess respiratory status and notify the nurse case manager as needed

Also known as: Device:Interactive

Interventional

Nurse case manager support OTHER

Support:Nurse Case Manager Phone Support . The nurse case manager will call patients under two conditions. The first is to provide regularly scheduled follow-up education and support.The nurse case manager will also phone patients in response to answers they have provided to the phone system. i.e Worsening COPD status

Interventional

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Montreal Chest Institute

Montreal, Quebec, H2X2P4, Canada

Location

Related Publications (1)

• 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.

  PMID: 31178998 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Bourbeau, MD, FRCPC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Respiratory Epidemiology and Clinical Research Unit, McGill University

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: October 15, 2013
• Primary Completion: June 8, 2016
• Study Completion: November 29, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

CA (1)