Triage of Reduced Exercise Tolerance in Frail Elderly

Study Overview
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Brief Summary
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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.

Official Title
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Triage of Reduced Exercise Tolerance in Frail Elderly

Conditions
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Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Index group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Index group<br>Patients in the index group receive the diagnostic triage instrument. This includes echocardiographic, electrocardiographic and spirometric measurements and blood testing. | Other: Index group<br>* Diagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing<br>* Other names: Diagnostic triage strategy;|
| No Intervention: Control<br>Participants receive care as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the diagnostic triage strategy | (Cost-)effectiveness of the diagnostic triage strategy. | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Elderly, Diagnosis, Primary health care