Please select the eligibility criteria that correspond to the clinical trial below.
Title: Triage of Reduced Exercise Tolerance in Frail Elderly
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* patients with diagnosed COPD via the medical records with code J44

Exclusion Criteria:

* terminal illness
* cognitive impairments
B: Inclusion Criteria:

To be eligible for inclusion in this study Patients fulfil all of the following criteria:

1. Written informed consent obtained before any assessment is performed.
2. Male and female patients ≥ 40 years of age
3. Diagnosis of COPD \[post-bronchodilator forced expiratory volume at one second (FEV1) \<80% predicted and FEV1/ forced vital capacity (FVC) \<75% without significant post-bronchodilator reversibility (\<10% FEV1 % predicted normal)\]
4. Optimal medical treatment according to GOLD without regular use of systemic corticosteroids
5. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
6. Absence of other significant diseases that could contribute to exercise limitation
7. At least 2 COPD exacerbations the year before the time entry

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions are applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

1. Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased.
2. Respiratory diseases other than COPD (e.g. asthma)
3. Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the tablet, as judged by the investigator
4. Patients not on optimal pharmacotherapy
5. No COPD exacerbations the year before the time entry
C: 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
D: Inclusion Criteria:

* The patient is categorised as asthmatic disease with persistent airway obstruction or COPD in the monitoring system SHL confirmed by the most recent lung function assessment (FEV1/FVC \< 70% after BD and FEV1 ≥ 50% pred after BD) or (FEV1 \< 80% predicted after BD and ≥ 9% reversibility)
* The patient is monitored by the AC service of the SHL.
* The GP of the patient is willing to participate in the trial.
* Written informed consent of participant

Exclusion Criteria:

* Patients treated primary by a pulmonologist
* Patients currently participating in another respiratory intervention study
* When the GP considers it detrimental to the patient to participate in the study
* Serious other non-pulmonary diseases (or disease-stages) that are presumed to lead to "lost to follow-up" because of the severity of the disease course (like diseases with low survival rate or mental deterioration)
* Serious other pulmonary diseases that effect bronchial symptoms and/or lung function, e.g. sarcoidosis, lung cancer, lung fibrosis
* Illiteracy

Answer: C