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Triage of Reduced Exercise Tolerance in Frail Elderly (TREE)

Primary Purpose

Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Index group
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Elderly, Diagnosis, Primary health care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General practionners " de Grebbe"

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Index group

Control

Arm Description

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

Participants receive care as usual.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effectiveness of the diagnostic triage strategy
(Cost-)effectiveness of the diagnostic triage strategy.
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.

Full Information

First Posted
June 17, 2010
Last Updated
July 4, 2014
Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01148719
Brief Title
Triage of Reduced Exercise Tolerance in Frail Elderly
Acronym
TREE
Official Title
Triage of Reduced Exercise Tolerance in Frail Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chronic Obstructive Pulmonary Disease
Keywords
Heart Failure, Chronic Obstructive Pulmonary Disease, Dyspnea, Elderly, Diagnosis, Primary health care

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
841 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Index group
Arm Type
Active Comparator
Arm Description
Patients in the index group receive the diagnostic triage instrument. This includes echocardiographic, electrocardiographic and spirometric measurements and blood testing.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive care as usual.
Intervention Type
Other
Intervention Name(s)
Index group
Other Intervention Name(s)
Diagnostic triage strategy
Intervention Description
Diagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing
Primary Outcome Measure Information:
Title
Prevalence of latent heart failure and COPD.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effectiveness of the diagnostic triage strategy
Description
(Cost-)effectiveness of the diagnostic triage strategy.
Time Frame
6 months
Title
Difference in prevalence of latent heart failure and COPD between both groups
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans H Rutten, Dr.
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
General practionners " de Grebbe"
City
Rhenen
ZIP/Postal Code
3911 ME
Country
Netherlands

12. IPD Sharing Statement

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Links:
URL
http://www.biomedcentral.com/1471-2458/12/385
Description
study protocol

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Triage of Reduced Exercise Tolerance in Frail Elderly

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