Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 50 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country.

About this study

Official title: Program of Integrated Care for Patients With Chronic Obstructive Pulmonary Disease and Multiple Comorbidities: A Randomized Controlled Trial

Conditions

Chronic Obstructive Pulmonary Disease, Multiple Comorbidity

Being tested

40 minute standardized education session, Individualized action plan, Individualized care plan, Standardized reinforcement/motivational interviewing and action plan teach-back sessions, Tele-home monitoring

Keywords

COPD, case management

Medical subject headings

Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 40 minute standardized education sessionBehavioural

  40 minute standardized education session based on the Living Well with COPD Patient's Education Tool on study enrolment to assess and improve understanding of disease and ability to monitor symptoms and recognize exacerbation

• Individualized action planBehavioural

  Individualized action plan using the Living Well with COPD template with patient individualized modification to address management strategies for exacerbation of comorbidity developed during the initial 40 minute session with case manager.

• Individualized care planBehavioural

  Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.

• Standardized reinforcement/motivational interviewing and action plan teach-back sessionsBehavioural

  Standardized reinforcement/motivational interviewing and action plan teach-back sessions based on Living Well with COPD modules as well as assessment of symptoms, progress and problems, and problem solving by phone weekly for 12 weeks, then monthly for 9 months (21 sessions) (telephone script; NOTE: case managers will make up to 3 attempts to contact participants during each week of the 12 weeks of weekly phone calls before determining inability to contact the participant for that week.

• Tele-home monitoringBehavioural

  Tele-home monitoring of SpO2, weight, dyspnea, sputum quantity and characteristics, and general well-being for maximum of 6 months.

  Inclusion criteria for tele-home monitoring:

  1. compatible phone line b. patient consent c. patient or caregiver demonstrated ability to use monitoring equipment d. patient unable to attend outpatient/community appointments for assessment and monitoring because of environmental barriers to access (e.g. physician's office only accessible by stairs) e. severe dyspnea on activities of daily living (Medical Research Council Questionnaire for Assessing Severity of Breathlessness [MRC] Class 4 \& 5 or modified MRC [mMRC] 3 \& 4) f. frequent ED visits (> 2) in last 12 months
  2. 12 weeks of clinical stability with no ED visits.

• Coordinated and improved communicationBehavioural

  Coordinated and improved communication between the patient, family caregivers, family physicians, specialists, and Community Care Access Centres (CCACs) facilitated by the case manager. This will include phone contact by case manager to family physicians and CCAC case manager if applicable after initial enrollment, education session and development of action plan, then monthly to report general status as well as after subsequent ED presentations/hospital admissions

• Priority accessBehavioural

  Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.

• Dictated patient summaryBehavioural

  Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)

• in-hospital rehabilitation/self-management programBehavioural

  Referral to an 8 week in-hospital rehabilitation and self-management education program for patients that are:

  1. have had a recent exacerbation, but are now clinically stable;
  2. symptomatic COPD including reduced activity levels and increased dyspnea despite pharmacological treatment;
  3. have stabilized comorbidity (no evidence of active ischemic, musculoskeletal, psychiatric or other systemic disease); and
  4. have sufficient motivation to participate.

• Smoking cessationBehavioural

  Referral to a smoking cessation program (as applicable)

• Action plan RespirologistBehavioural

  Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.

• Web based self management materialsBehavioural

  Referral to educational materials and resources (Living Well with COPD module printouts provided during COPD rehabilitation classes at a cost to the individual)

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The number of ED presentations

   Measured: 1 year after randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Jul 2012 (estimated)
2. Study startAug 2012
3. Primary completionDec 2015
4. Study completionDec 2015

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.