Triage of Reduced Exercise Tolerance in Frail Elderly

NCT01148719 | Completed

• 3 other identifiers: 311040302NL30278.041.10NTR2336
• Study Type: interventional
• Target: 841
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease

Keywords

Heart Failure; Chronic Obstructive Pulmonary Disease; Dyspnea; Elderly; Diagnosis; Primary health care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effectiveness of the diagnostic triage strategy

  6 months

• Difference in prevalence of latent heart failure and COPD between both groups

  6 months

Study Arms (2)

Index group

ACTIVE COMPARATOR

Patients in the index group receive the diagnostic triage instrument. This includes echocardiographic, electrocardiographic and spirometric measurements and blood testing.

Other: Index group

Control

NO INTERVENTION

Participants receive care as usual.

Interventions

Index group OTHER

Diagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing

Also known as: Diagnostic triage strategy

Index group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

General practionners " de Grebbe"

Rhenen, 3911 ME, Netherlands

Location

Related Publications (24)

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• van Mourik Y, Rutten FH, Bertens LCM, Cramer MJM, Lammers JJ, Gohar A, Reitsma JB, Moons KGM, Hoes AW. Clinical research study implementation of case-finding strategies for heart failure and chronic obstructive pulmonary disease in the elderly with reduced exercise tolerance or dyspnea: A cluster randomized trial. Am Heart J. 2020 Feb;220:73-81. doi: 10.1016/j.ahj.2019.08.021. Epub 2019 Sep 1.

  PMID: 31790904 DERIVED

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• van Mourik Y, Moons KG, Bertens LC, Reitsma JB, Hoes AW, Rutten FH. Triage of frail elderly with reduced exercise tolerance in primary care (TREE). A clustered randomized diagnostic study. BMC Public Health. 2012 May 28;12:385. doi: 10.1186/1471-2458-12-385.

  PMID: 22640176 DERIVED

Related Links

• study protocol

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive; Dyspnea; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Frans H Rutten, Dr.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

NL (1)