Examine the Impact of Early Education on COPD Management

NCT02398643 | Completed

• 2 other identifiers: REB14-0504AIHS-CRIO Project Grant
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. COPD creates a tremendous burden to the healthcare system, as disease exacerbations result in frequent, prolonged hospitalizations. While originally considered a disease specific to the lung, data has shown that COPD is associated with substantial cardiovascular (CV) morbidity and mortality. Exacerbations of COPD requiring hospitalization result in marked patient deterioration, and heightened CV risk. The cause of the increased CV risk with stable COPD, and the exaggerated CV risk during exacerbations of the disease are unknown; however, it may be due to chronic inflammation which is exacerbated with a flare-up of the disease, and/or chronic inactivity which is similarly worsened with bed-rest during a hospitalization. Despite the impact of COPD on healthcare, there are relatively few studies examining how COPD inpatient care impacts on patient outcomes, inflammation and CV risk. Disease management programs, such as pulmonary rehabilitation and patient self-management education, are part of guideline therapy for COPD; however, these are not regularly implemented following a hospitalization, and how these interventions affect patient outcomes, behavior, physical activity, inflammation and CV risk have not been well studied. The proposed long-term project will examine how early referral to chronic disease management programs after hospital discharge, affect patient outcomes. This study will provide invaluable information about outpatient management for a disease which has a tremendous impact on healthcare.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Acute Exacerbation of COPD; COPD; Emphysema; Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• Vascular Function

  Peripheral arterial tone (PAT) and arterial stiffness will be used to assess vascular function.

  Change in baseline vascular function post respiratory education and 6 months

Secondary Outcomes (10)

• Inflammatory markers (IL-6)

  Change in baseline IL-6 post respiratory education and 6 months

• Inflammatory markers (TNF-alpha)

  Change in baseline TNF-alpha post respiratory education and 6 months

• Inflammatory markers (MMP-2)

  Change in baseline MMP-2 post respiratory education and 6 months

• Inflammatory markers (CRP)

  Change in baseline CRP post respiratory education and 6 months

• Quality of Life (QoL)

  Change in baseline Quality of Life post respiratory education and 6 months

Study Arms (2)

Early Pulmonary Education (EPE)

OTHER

Patients randomized to EPE will receive focused education sessions by a Certified Respiratory Educator. Education sessions will start within two weeks of discharge from hospital.

Other: Pulmonary Education (PE)

Usual Care

OTHER

Patients randomized to usual care will receive general education sessions by a Certified Respiratory Educator within the month of being discharged.

Other: Usual Care

Interventions

Pulmonary Education (PE) OTHER

Patients enrolled in PE will undergo focused education sessions following discharge from hospital.

Early Pulmonary Education (EPE)

Usual Care OTHER

Patients enrolled in usual care will receive general education sessions following discharge from hospital.

Usual Care

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the pulmonary ward for an AECOPD will be offered participation into this arm of the study.

You may not qualify if:

• Patients found to have an acute cardiac injury during admission, mobility issues or residence outside the greater Calgary area will be excluded.

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N4Z6, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

CA (1)