Trial of Education and Compliance in Heart Dysfunction (TEACH)

November 14, 2007 updated by: London Health Sciences Centre

Trial of Education and Compliance in Heart Dysfunction. A Study Measuring the Impact of Multi-Disciplinary Education as an Intervention to Increase Patient Concordance and the Cost Effectiveness of Treatment in Patients With Heart Dysfunction

The emphasis of this grant is to investigate ways to educate patients, not only to improve their knowledge about medications and diet that are important for better outcomes in heart failure, but also to try to understand how patients' beliefs about medication and diet affect their behaviour and to what extent the investigators can help patients change.

Hypotheses: Heart failure patients who receive an enhanced educational intervention from their community pharmacist will:

  1. have an absolute risk reduction in the number of events of 20%,
  2. be more compliant,
  3. demonstrate less health-related quality of life (HRQoL) impairment as measured by disease-specific and generic HRQoL instruments and
  4. have lower costs/quality adjusted life years due to fewer total events per patient.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION: Heart Failure (HF) is one of the leading causes of hospitalization in Canada. While great advances have been made in the treatment of this disease, factors limiting the effectiveness of treatment include: poor compliance to dietary guidelines and medications, patients' lack of understanding about the impact of their disease, a lack of understanding of the impact of their lifestyle habits on their disease and the lack of systematic monitoring of patients following hospitalization. The objective of this trial of education and compliance in heart failure patients (TEACH) is to measure in patients with heart failure who are hospitalized and then discharged into the community, the impact of a comprehensive outpatient educational intervention on:

  1. a composite endpoint of mortality, readmissions and visits to the emergency room for all causes,
  2. the impact of the intervention on health-related quality of life,
  3. the impact of the intervention on compliance to medication and
  4. the economic impact of providing such an intervention to patients. A unique component of this study is the participation of community pharmacists as part of a seamless care model and the economic and qualitative evaluation of the educational interventions.

RESEARCH DESIGN: This is a prospective, randomized controlled clinical trial in patients who are admitted to the hospital with a diagnosis of heart failure. Patients are stratified by reason for admission to the hospital. Stratum 1 includes patients whose primary reason for admission is HF and stratum 2 includes patients whose primary reason for hospital admission is not HF. The randomization will follow a cluster randomization design such that the community pharmacies will be randomized to deliver either an intervention (INTERVENTION) or usual care (CONTROL). Patients will be assigned to one of the two arms contingent upon which pharmacy they obtain most of their medications from. All patients receive standardized in-hospital education that has been previously validated (Eur J of HF, in press 2003). This education consists of educational booklets and videos on HF, health promotion and dietary information as well as relevant intervention from their community pharmacist that is aimed at helping the patients become more compliant with their medication and provide a framework of understanding that helps persistence.

HYPOTHESIS: HF patients who receive an enhanced educational intervention from their community pharmacist will:

  1. have an absolute risk reduction in the number of events of 20%,
  2. be more compliant,
  3. demonstrate less health-related quality of life (HRQoL) impairment as measured by disease-specific and generic HRQoL instruments and
  4. lower costs/quality adjusted life years (QALY) due to fewer total events per patient.

OUTCOMES: Outcomes are collected every 3 months from baseline to end of one year. Events are tracked using a comprehensive database that we have developed and validated. Further utilization data will be provided by ICES data linkage facilities and patient interviews at the time of outcome assessment. In order to measure compliance we will continue to use electronic measures known as Track Caps (MEMS). The other indirect measure is pharmacy refill data that is provided to us from all community pharmacies the patient uses. This data will be interpreted using a validated formula developed by Steiner et al. (1996). Resource use and clinical outcomes are also collected.

IMPORTANCE: Medication used to treat HF and other chronic diseases can only work, if used. We are providing a validated education intervention to patients through an existing community infrastructure with an aim to reduce morbidity and mortality and have a positive impact on HRQoL within a cost-effective framework.

Study Type

Interventional

Enrollment (Anticipated)

383

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4G5
      • Windsor, Ontario, Canada, N9A 1E1
        • Recruiting
        • Hotel Dieu Grace Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical history of dyspnea
  • Concurrent physical exam consistent with rales, S3, elevated JVP, pedal oedema
  • Heart failure (HF) confirmed by attending physician, if patient is assessed by house staff
  • Left ventricular ejection fraction (LVEF) < 40% on echocardiogram, nuclear scan or contrast ventriculography
  • Indications for chronic medical treatment for HF
  • Able and willing to give informed consent
  • Over 18 years of age
  • Live within London, Ontario and surrounding area, defined by the boundaries as the London and District Pharmacists' Association

Exclusion Criteria:

  • Planned surgical correction for HF within 12 months
  • Cor pulmonale and only right ventricular failure
  • Chronic renal failure on dialysis (these patients are followed by nephrology educators)
  • Other illnesses with survival anticipated for < 12 months
  • Dementia documented by attending physician
  • Psychiatric illness that makes it impossible to respond to education through the community pharmacist
  • Planned discharge to long term institution
  • Barrier to teaching (English is not the first language AND caregiver cannot provide translation to the patient to elicit the patient's responses)
  • Severe alcohol or drug abuse
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Outcomes: data collected on all cause mortality, all cause readmissions and all cause emergency room visits
Time Frame: at one year
at one year

Secondary Outcome Measures

Outcome Measure
Medication compliance
Baseline outcome measurements and quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre

Investigators

  • Principal Investigator: Femida H Gwadry-Sridhar, PhD, London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2007

Last Update Submitted That Met QC Criteria

November 14, 2007

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09091E
  • HSFO NA-5047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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