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Strategy to Recognize and Initiate Treatment of Chronic Heart Failure (STRETCH)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Training of general practitioners in an uptitration protocol.
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Diagnosis, Treatment, Primary care

Eligibility Criteria

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

Inclusion Criteria:

  • Age 65 years or over
  • Shortness of breath as reason for GP contact in the previous 12 months

Exclusion Criteria:

  • Already established heart failure, that is a diagnosis of heart failure confirmed by the cardiologist with echocardiography
  • A life expectancy shorter than 6 months
  • Not being able to give informed consent

Sites / Locations

  • Julius Center for Health Sciences and Primary care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

General practitioners of patients in the intervention group will receive detailed instructions on uptitration of ACE-inhibitors and beta-blockers before the inclusion of participants.

Patients in the control group receive care-as-usual. Their general practitioner will not be trained in applying the uptitration protocol.

Outcomes

Primary Outcome Measures

Prevalence of heart failure in elderly who presented to the general practitioner with shortness of breath on exertion.
Differences in walking distance between the intervention and control group.
This outcome was added because of its relevance for patients with heart failure in April 2011. The change in study protocol was communicated to and approved by the Medical Ethics Committee of the UMC Utrecht.
Differences in quality of life between the intervention and control group.
Differences in prescription of heart failure medication between the intervention and control group.
Differences in (heart failure related) doctor-appointments and hospitalization rates between the intervention and control group.

Secondary Outcome Measures

Cost-effectiveness of the implemented diagnostic-therapeutic strategy.

Full Information

First Posted
September 14, 2010
Last Updated
July 7, 2015
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT01202006
Brief Title
Strategy to Recognize and Initiate Treatment of Chronic Heart Failure
Acronym
STRETCH
Official Title
A Combined Diagnostic-therapeutic Strategy to Optimize Management of Patients With Previously Unrecognized Heart Failure in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a structured diagnostic-therapeutic strategy to detect and treat previously unrecognized (or unestablished) heart failure in primary care will improve the functional capacity, quality of care, the quality of life, and eventually the prognosis of these patients.
Detailed Description
Heart failure is an emerging epidemic in especially the elderly, with high mortality rates, substantial loss in quality of life, and high healthcare costs, mainly due to hospitalizations. The majority of (usually elderly) patients with heart failure are diagnosed and managed in primary care. However underdiagnosis and undertreatment of patients with heart failure in primary care are common. Implementation of a standardized diagnostic protocol together with educating general practitioners in a pragmatic treatment strategy in which the focus lays on uptitration of heartfailure medication, would fill the gap of underdiagnosis and undertreatment that nowadays exists in primary care. All participants will undergo a standardized diagnostic work-up to establish or rule out heart failure. In those participants with an abnormal ECG and/or elevated natriuretic peptide level additional echocardiography will be performed at the outpatient clinic of the Diakonessenhuis in Zeist. The definite diagnosis of heart failure ('systolic' or 'diastolic') will be established by an expert panel consisting of two cardiologists and a general practitioner. The panel will apply the criteria of the updated heart failure guidelines (2008) of the European Society of Cardiology (ESC). Patients with heart failure will subsequently be treated by their own general practitioner. The participating general practitioners will be randomly divided into either care as usual (control group) or special uptitration (intervention group). Both groups will be using medication as recommended in the Dutch heart failure standard. However, general practitioners in the intervention group will be especially trained in the practical appliance of this guideline: the initiation of diuretics and ACE-inhibitors and structured uptitration of ACE-inhibitors and beta-blockers. In the training, practical examples will be used concerning barriers the general practitioners themselves encountered when using this medication. In the intervention group, patients with 'systolic' heart failure will receive the recommended maximal dose or the highest tolerated dose. Patients with 'diastolic' heart failure will receive optimal blood pressure and heart rate control with the preferred cardiovascular drugs. At baseline and six months after heart failure is established or ruled out, participants are asked to perform the six-minute walk test and fill out quality of life questionnaires. During those six months, only participants with heart failure will additionally fill out one of these questionnaires every three weeks. Also after six months, electronical files of the general practitioners will be scrutinized to assess the (dosage of) prescribed medication and visits to general practice and cardiology department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Diagnosis, Treatment, Primary care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
585 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
General practitioners of patients in the intervention group will receive detailed instructions on uptitration of ACE-inhibitors and beta-blockers before the inclusion of participants.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control group receive care-as-usual. Their general practitioner will not be trained in applying the uptitration protocol.
Intervention Type
Other
Intervention Name(s)
Training of general practitioners in an uptitration protocol.
Intervention Description
The general practitioners randomly allocated to the intervention group will be trained in the practical appliance of the Dutch GP's 'heart failure' guideline. They will receive detailed instructions on initiating diuretics with ACE-inhibitors and uptitration of ACE-inhibitors and beta-blockers.
Primary Outcome Measure Information:
Title
Prevalence of heart failure in elderly who presented to the general practitioner with shortness of breath on exertion.
Time Frame
one year
Title
Differences in walking distance between the intervention and control group.
Description
This outcome was added because of its relevance for patients with heart failure in April 2011. The change in study protocol was communicated to and approved by the Medical Ethics Committee of the UMC Utrecht.
Time Frame
6 months
Title
Differences in quality of life between the intervention and control group.
Time Frame
6 months
Title
Differences in prescription of heart failure medication between the intervention and control group.
Time Frame
6 months
Title
Differences in (heart failure related) doctor-appointments and hospitalization rates between the intervention and control group.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness of the implemented diagnostic-therapeutic strategy.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65 years or over Shortness of breath as reason for GP contact in the previous 12 months Exclusion Criteria: Already established heart failure, that is a diagnosis of heart failure confirmed by the cardiologist with echocardiography A life expectancy shorter than 6 months Not being able to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans H Rutten, MD, PhD
Organizational Affiliation
Julius Center for Health Sciences and Primary care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Julius Center for Health Sciences and Primary care
City
Utrecht
ZIP/Postal Code
3584 CG
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26880668
Citation
van Riet EE, Hoes AW, Limburg A, Landman MA, Kemperman H, Rutten FH. Extended prediction rule to optimise early detection of heart failure in older persons with non-acute shortness of breath: a cross-sectional study. BMJ Open. 2016 Feb 15;6(2):e008225. doi: 10.1136/bmjopen-2015-008225.
Results Reference
derived
PubMed Identifier
24400643
Citation
van Riet EE, Hoes AW, Limburg A, van der Hoeven H, Landman MA, Rutten FH. Strategy to recognize and initiate treatment of chronic heart failure in primary care (STRETCH): a cluster randomized trial. BMC Cardiovasc Disord. 2014 Jan 8;14:1. doi: 10.1186/1471-2261-14-1.
Results Reference
derived

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Strategy to Recognize and Initiate Treatment of Chronic Heart Failure

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