Please select the arm or intervention descriptions that belong 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: Arm Label: Index group; Type: ACTIVE_COMPARATOR; Interventions: Other: Index group | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Index group; Assigned to Arm(s): Index group
B: Arm Label: Health Coaching; Type: EXPERIMENTAL; Interventions: Behavioral: Health coaching by medical assistants in primary care | Intervention Type: BEHAVIORAL; Name: Health coaching by medical assistants in primary care; Assigned to Arm(s): Health Coaching
C: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Intensive diabetes self-management education | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced standard diabetes education | Intervention Type: BEHAVIORAL; Name: Intensive diabetes self-management education; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Enhanced standard diabetes education; Assigned to Arm(s): Control Group
D: Arm Label: Home Telemonitoring; Type: EXPERIMENTAL; Interventions: Device: Intel Health Guide | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care | Intervention Type: DEVICE; Name: Intel Health Guide; Assigned to Arm(s): Home Telemonitoring | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care

Answer: A