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Clinical Trials/NCT02483494
NCT02483494
Unknown
Not Applicable

Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions and Health Related Outcomes Amongst Patients Post Acute Myocardial Infarction: ALTRA Study

National University Heart Centre, Singapore1 site in 1 country300 target enrollmentJuly 8, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Myocardial Infarction
Sponsor
National University Heart Centre, Singapore
Enrollment
300
Locations
1
Primary Endpoint
Readmissions Days
Last Updated
8 years ago

Overview

Brief Summary

Aim. To develop and examine the effectiveness of an APN-led telehealth rehabilitative programme as a transitional nursing therapeutic on readmission rates and health related outcomes amongst patients with Acute Myocardial Infarction (AMI) post discharge.

Design. Randomized controlled trial with repeated measures.

Methodology. A consecutive sampling of 172 patients with AMI will be recruited from a tertiary hospital in Singapore. Participants will be randomised into two groups. The experimental group (ALTRA) will receive APN-led telehealth rehabilitative programme upon discharge in addition to standard care. The control group will receive only standard follow-up care.

Detailed Description

Ischaemic heart disease is the third leading cause both for death and illness for hospitalisation in Singapore. Epidemiological data shows that the incidence of acute myocardial infarction (AMI) stands around 7000 plus in Singapore. In United States, nearly 20% of patients with AMI are readmitted within 30 days of discharge causing the healthcare system a huge financial burden. These readmissions have been shown to be associated with lower patient satisfaction and less inefficient healthcare. Cardiac rehabilitation has been proven to be an effective strategy in improving quality of life and reducing readmission. However, this structured programme which comprise of clinical review, education and exercise, has poor uptake rate for varied reasons. It is important that newer strategies are being explored and developed to cater to the changing needs of the patient population. One of which is to utilize telemedicine with combination of Advanced Practice Nurse delivering the care remotely. This is a substudy of IMMACULATE STUDY (NCT02468349) where more details can be found.

Registry
clinicaltrials.gov
Start Date
July 8, 2015
End Date
June 30, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National University Heart Centre, Singapore
Responsible Party
Principal Investigator
Principal Investigator

Karen Koh

Assistant Director of Nursing

National University Heart Centre, Singapore

Eligibility Criteria

Inclusion Criteria

  • Typical history of ischemic chest pain or angina equivalent symptoms (e.g. acute onset dyspnea)\> 30 minutes
  • Undergone PCI for index event
  • NT-Pro-BNP ≥1000 ng/L
  • Cinically diagnosed AMI at high risk of ventricular remodeling (STEMI or NSTEMI):
  • (Anterior or large inferior STEMI)
  • ECG changes\>0.1mV ST segment elevation in two or more contiguous limb leads or precordial leads or
  • Presence of pathological Q waves in two or more contiguous limb leads or precordial leads.
  • Typical rise or fall of cardiac enzymes (cardiac troponin value exceeding the 99th percentile).
  • Angiographic findings of proximal/mid LAD, proximal LCX or RCA occlusion for STEMI.
  • (Or NSTEMI with)

Exclusion Criteria

  • Hypersensitivity to ticagrelor, aspirin or any excipients
  • Active pathological bleeding
  • History of intracranial haemorrhage
  • Infection within 6 weeks preceding the primary angioplasty, inflammatory disorders, Hepatitis, HIV, autoimmune disease or on immunosuppressive therapy
  • Women of childbearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period.
  • History of non-ischaemic cardiomyopathy or malignancy
  • History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR)
  • Planned CABG within the next 6 weeks
  • Cardiogenic shock unable to be weaned off inotropes or IABP
  • Asthma or any other contraindications to beta-blockers

Outcomes

Primary Outcomes

Readmissions Days

Time Frame: 30 days

Cardiac and non-cardiac causes Readmission days per 1000 follow up days will be calculated using the total number of sample in that arm x follow days (i.e. 30 days in this instance) as the denominator. (Please refer to references attached)

Secondary Outcomes

  • Readmissions Days Per 1000 follow up days(6 months)
  • EuroQoL(6 months)
  • ED visits or unplanned self-reported doctor visits(6 months)
  • Cardiac Self-Efficacy Scale(6 months)
  • Myocardial Infarction Dimension Assessment Scale(6 months)
  • Hospital Anxiety and Depression Scale(6 months)

Study Sites (1)

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