Heart Failure Clinical Trial
— TREEOfficial title:
Triage of Reduced Exercise Tolerance in Frail Elderly
Background of the study:
Many elderly suffer from reduced exercise tolerance or exercise induced shortness of breath
(dyspnoea) which causes decreased mobility and restrictions in physical, psychological and
social functioning. Patients commonly attribute this symptom to their age, and simply adjust
their life style to it. Reduced exercise tolerance/dyspnoea is very common with prevalence
rate of 20-60% of those aged 65 years and over. The main causus in the elderly are heart
failure and chronic obstructive pulmonary disease (COPD). Both diseases have a high negative
impact on the quality of life and are associated with frequent hospital admissions.
Over-diagnosis, but more often under-diagnosis of heart failure and COPD is rather common in
primary care. Establishing a diagnosis early in the course of the disease is useful because
both diseases can be adequately and evidence-based treated. Therefore, an easy diagnostic
triage-strategy followed bij direct treatment would be of great importance to asses and
treat heart failure and COPD in elderly patient with shortness of breath.
Objective of the study:
Quantify how many frail elderly aged over 65 years with reduced exercise tolerance and/or
exercise induced dyspnoea have previously unrecognised COPD and heart failure. Quantify the
difference in prevalence of unrecognised COPD and heart failure between those who underwent
the diagnostic triage compared to those who received care as usual. Quantify the effect of
the diagnostic triage plus the additionally treatment changes on functionality and quality
of life after 6 months compared to those who received care as usual. Quantify the
cost-effectiveness of the diagnostic triage strategy compared to care as usual
Study design:
A clustered randomized diagnostic (follow-up) study
Study population:
First, pre-selection of patients aged over 65 years from 50 general practices is based on
frailty. Frailty is based on the next criteria: use 5 or more different types of medical
drugs chronically in the last year and/or have 3 or more chronic or vitality treating
diseases (such as diabetes mellitus, COPD, heart failure, impaired vision). This will be
done from the electronic medical files of the general practices. These elderly will receive
the MRC questionnaire of dyspnoea and three additional questions related tot exercise
intolerance. Those with any dyspnoea and/or reduced exercise tolerance will be invited to
participate, except those with established heart failure and COPD.
Study parameters/outcome of the study:
Prevalence of latent heart failure and COPD. Difference in prevalence of latent heart
failure and COPD between both groups.
Differences in functionality and quality of life after 6 months between both groups.
Cost-effectiveness and experienced patient burden of the diagnostic triage strategy.
Status | Completed |
Enrollment | 841 |
Est. completion date | September 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - patients aged 65 years and older - must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year - must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires) Exclusion Criteria: - patients with both confirmed COPD and heart failure (Spirometry performed < 1 year ago and heart failure confirmed by echocardiography) - patients unable or unwilling to sign informed consent |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | General practionners " de Grebbe" | Rhenen |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of latent heart failure and COPD. | Prevalence of latent heart failure and COPD. The prevalence in the index-group is calculated after all investigations are done. The prevalence in de control-group is derived from the electronical medical files of the general practitioner after a follow-up period of six months. | 6 months | No |
Secondary | Effectiveness of the diagnostic triage strategy | (Cost-)effectiveness of the diagnostic triage strategy. | 6 months | No |
Secondary | Difference in prevalence of latent heart failure and COPD between both groups | Difference in prevalence of latent heart failure and COPD between both groups. The prevalence in index-group is calculated after all investigations are done. The prevalence in de control-group is derived from the electronical medical files of the general practitioner after a follow-up period of six months. | 6 months | No |
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