AzTrials
AzTrials

Heart FailurePhase 2/3NCT00202150

Primary Care Management/Action Plans for Advanced Chronic Diseases

A Phase 2/3 study testing Application of a management action plan in people with Heart Failure and Chronic Obstructive Lung Disease, run by Queen's University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Patients living with advanced chronic diseases (ACD), such as congestive heart failure (CHF) and chronic obstructive lung disease (COPD) present substantial care and economic challenges for the health care system due to frequent emergency room visits and acute care hospitalizations. Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Application of a management action plan
How many people
139 participants
Where
1 siteCanada
Study dates
Sep 2004to Sep 2006
Phase
Phase 2/3
Are there results?
None posted in the registry

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

Who may be able to join

  • diagnosis of Chronic Heart Failure
  • diagnosis of Chronic Obstructive Pulmonary Disease

Who cannot join

  • living in a nursing home
  • inability to give informed consent
  • involved in other studies of CHF or COPD

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Studies in Primary Care

    Kingston, Ontario, K7L 5E9

Other trials in Canada

About this study

Official title: Primary Care Management/Action Plans for Advanced Chronic Diseases (The RoadMAP Project)

Patients living with advanced chronic diseases (ACD), such as congestive heart failure (CHF) and chronic obstructive lung disease (COPD) present substantial care and economic challenges for the health care system due to frequent emergency room visits and acute care hospitalizations. Morbidity and mortality is high in these complex populations, and patient quality of life is often compromised.

Care of patients with ACD occurs across health care sectors, by providers in the acute, primary and community settings. Despite recent efforts to enhance the care of patients with ACD, through multidisciplinary disease management programs, variations and gaps exist along the continuum of care. The available evidence suggests that there are opportunities to optimize the primary care of patients with ACD. We are proposing to build upon the current evidence and guidelines for disease management programs, our existing specialized resources, our existing primary care practices, and develop and test a model of care that is primary care based, sensitive to the unique demands and characteristics of different primary practices. Our goal is to design linkages and care strategies of relevance and importance to the primary care providers who care for patients with advanced COPD and CHF.

This demonstration project is a randomized controlled clinical trial of the RoadMAP program (intervention) delivered by a Primary Care Nurse Specialist (PCNS) compared to usual care (control group). The primary outcomes will be degree of adherence to clinical practice guidelines. Secondary outcomes will be patient satisfaction, quality of life, use of community-based services, number of emergency room visits, and number of hospitalizations.

Read the detailed description

The available evidence suggests that there are opportunities to optimize the primary care of patients with ACD. We are proposing to build upon the current evidence and guidelines for disease management programs, our existing specialized resources, our existing primary care practices, and develop and test a model of care that is primary care based, sensitive to the unique demands and characteristics of different primary practices. Our goal is to design linkage and care strategies of relevance and importance to the primary care providers who care for patients with advanced COPD and CHF.

The study is a randomized controlled clinical trial of the RoadMAP program (intervention) delivered by a PCNS compared to usual care (control group). The primary outcome will be degree of adherence to clinical practice guidelines. Secondary outcomes will be patient satisfaction, quality of life, use of community-based services, number of emergency room visits, and number of hospitalizations. The purpose of the RoadMAP program is to improve the care of people with advanced stage COPD and CHF. Specifically, activities will be aimed at improving patients' self care ability, facilitating access to the most appropriate services, ensuring medical treatment according to consensus guidelines and promoting consistency of health care communication. Adherence to guidelines is a process that involves activities by the patient, PCNS, and the Primary Care Physician. The PCNS would follow-up the patient again at approximately one month after initial contact and then every 3 months, to assess and monitor adherence to the proposed MAP by the patient, the physician, and the nurse. Patients will have the option of returning to the physician office or to be monitored by phone. An office visit will be recommended if there is a perceived need for medical assessment and intervention. The family physician would continue to see the patient as required in order to carry out the medical portion of the MAP and to deal with other primary care problems as needed. Additionally, the PCNS would be available to work with nurses and other health professionals in each primary care practice in the provision of care to the ACD patients.

Being tested
Application of a management action plan
Keywords
Advanced chronic diseases, Heart failure, Chronic obstructive lung disease, primary care, Chronic Care
Medical subject headings
Heart Failure, Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Application of a management action planBehavioural

What is being measured

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

  1. Degree of adherence to the clinical practice guidelines.

Secondary outcomes (6)
  1. Patient satisfaction

  2. General health related quality of life

  3. Therapeutic Self Care

  4. Number of referrals to community-based services

  5. Number of emergency room visits annually

  6. Number of hospitalizations annually

Timeline

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

  1. First posted20 Sep 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00202150
Sponsor's protocol ID
G03-02765
Status last verified
Mar 2015
First submitted
13 Sep 2005
Last updated
11 Mar 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Application of a management action plan in people with Heart Failure and Chronic Obstructive Lung Disease, run by Queen's University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of adherence to the clinical practice guidelines.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in