- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02463786
Improving Knowledge To Efficaciously RAise Level of Contemporary Treatment in Heart Failure ( (INTERACTinHF)
August 20, 2018 updated by: Maastricht University Medical Center
Improving Knowledge To Efficaciously RAise Level of Contemporary Treatment in Heart Failure
Heart failure (HF) remains to have a poor outcome.
Even though recent advances in HF led to a reduction of morbidity and mortality, improvement in outcome is much less than expected based on large randomized trials.
Various reasons may be responsible, such as complexity of disease and comorbidities, inadequate diagnosis and inappropriate treatment.
So far, little attention has been paid on patients seen in primary care.
Also, HF care mainly focuses on the individual patient-doctor relationship.
However, the increasing complexity prevents individual physicians from covering all aspects of care.
Consequently, multiple stakeholders are involved, including both general practitioners and specialists.
Still, the relative role, the interaction between them and the processes included are hardly defined.
These aspects may not only be relevant for patient care, but also for the setup of health care systems.
Whereas multidisciplinary team should resemble a seamless system across primary and hospital care, there is a scarcity of research considering how these disease management programs perform, in what form they should be offered, and what care and support patients and caregivers would benefit most.The INTERACT-in HF (Improving kNowldege Transfer to Efficaciously RAise level of Contemporary Treatment in Heart Failure) study is set up to determine and assess relevant factors of the quality of HF care.
The study evaluates processes of HF care, role of relevant care givers and interactions between them.
It collects data from individual patients to assess characteristics and management of contemporary HF patients.
This is performed in different countries (the Netherlands, Belgium and Germany) to analyze decision making with respect to diagnostics and treatment.Cross-sectional mixed-methods are used.
Patients and their caregivers are interviewed.
The patient is the central starting point.
Then, the treating GP, cardiologist and HF nurse are interviewed.
In parallel, retrospective data based on records from these patients are reviewed to verify data from interviews and to determine characteristics of them.
Retrospective data of additional patients are collected to complete the picture of the current situation.
These data will be used to define bottlenecks that prevent best clinical practice to be used in daily care at all levels, comparing practice in different countries.Thus, the proposal aims to better understand HF care, which will lead to a better care and finally to improved outcome.
Study Overview
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Maastricht, Netherlands, 6229 AZ
- MUMC
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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
Sampling Method
Probability Sample
Study Population
Patients with the following inclusion criteria are suitable for participation in the study: age ≥18 years, signs, diagnosis or suspicion of heart failure and are contractually capable and mentally able to understand and follow the instructions of the study personnel (i.e.
speaking and understanding the local language, being able to have a conversation for about an hour, being able to hear and speak).
All subjects have to be able to give informed consent.
Patients who had undergone heart transplantation are excluded.
Otherwise, no exclusion criteria apply.
The health care providers of these patients (cardiologists, GP's and HF-nurses) are also contacted to participate in this study.
Description
Inclusion Criteria:
Patients with the following inclusion criteria are suitable for participation in the study:
- age ≥18 years,
- signs, diagnosis or suspicion of heart failure and
- are contractually capable and mentally able to understand and follow the instructions of the study personnel (i.e. speaking and understanding the local language, being able to have a conversation for about an hour, being able to hear and speak).
- All subjects have to be able to give informed consent. The health care providers of these patients (cardiologists, GP's and HF-nurses) are also contacted to participate in this study.
Exclusion Criteria:
- patient who had a heart transplantation
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of heartfailure patients characteristics in primary and secondary care
Time Frame: at baseline
|
at baseline
|
Baseline descriptives of heart failure patients
Time Frame: at baseline
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Questionnairs: Self care behavior scale
Time Frame: at baseline
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at baseline
|
Questionaaire: Dutch heart failure knowlegde scale
Time Frame: at baseline
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at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
July 1, 2012
Primary Completion (Actual)
June 30, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
March 16, 2015
First Submitted That Met QC Criteria
June 2, 2015
First Posted (Estimate)
June 4, 2015
Study Record Updates
Last Update Posted (Actual)
August 21, 2018
Last Update Submitted That Met QC Criteria
August 20, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 12-4-074
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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