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

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

Interventions

BEHAVIORAL

COPD self-management using an action plan

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.

DEVICE

Telesystem-Phone self-assessment/reporting system

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

OTHER

Nurse case manager support

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

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

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

  lead OTHER

Principal Investigators

• Jean Bourbeau, MD, FRCPC · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-15

Primary Completion

2016-06-08

Completion

2017-11-29

Countries

• Canada

Study Locations