Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211289
Status:
UNKNOWN
Last Update Posted:
2007-11-15
First Post:
2005-09-13
Brief Title:
Trial of Education and Compliance in Heart Dysfunction TEACH
Sponsor:
London Health Sciences Centre
Organization:
London Health Sciences Centre
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 costsquality adjusted life years due to fewer total events per patient
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 costsquality adjusted life years due to fewer total events per patient
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 costsquality 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
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 costsquality 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSFO NA-5047 | None | None | None |