Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions (ALTRA)

August 3, 2017 updated by: Karen Koh, National University Heart Centre, Singapore

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

  • Typical rise or fall of cardiac enzymes (cTn value exceeding the 99th percentile).
  • Peak cTnI should be >10ug/L, TnT-hs>250 ng/L or CK-MB >80 IU/L
  • LVEF (echocardiography) ≤ 40% or Kilip class ≥2

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
  • Arrhythmias precluding proper CMR image acquisition, including atrial fibrillation and frequent atrial or ventricular ectopy of > 1 in 5 intrinsic ECG complexes
  • Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants
  • Significant liver impairment
  • Renal impairment (eGFR<45 ml min -1), end stage renal failure on renal replacement therapy
  • Anaemia (Hb<10 g/dL)
  • Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders)
  • Participants who cannot be followed up
  • Participants not able or willing to consent for study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APN-led Telemedicine
Participants will receive APN-led Telemedicine in addition to usual care.
Other: APN-led Telemedicine

Allocation to experimental or Usual care is 1:1.

The four study APNs will be delivering the care and have at least three years working experiences in coronary care settings. A telephonic script and study protocol is made available to ensure standardization of intervention.
No Intervention: Usual care
Participants will receive the standard of care which includes education by cardiac care nurses and face-to-face consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmissions Days Per 1000 follow up days
Time Frame: 6 months
Cardiac and non-cardiac causes
6 months
ED visits or unplanned self-reported doctor visits
Time Frame: 6 months
Cardiac and non-cardiac causes
6 months
Cardiac Self-Efficacy Scale
Time Frame: 6 months
Health Related Outcomes
6 months
Myocardial Infarction Dimension Assessment Scale
Time Frame: 6 months
Health Related Outcomes
6 months
EuroQoL
Time Frame: 6 months
Health Related Outcomes
6 months
Hospital Anxiety and Depression Scale
Time Frame: 6 months
Health Related Outcomes
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Heart Centre, Singapore

Collaborators

National University Hospital, Singapore

Investigators

  • Principal Investigator: Karen Koh, National University Heart Centre, Singapore
  • Study Chair: A Mark Richards, National University Heart Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2015

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014\00793
  • RG2013/03 (Other Grant/Funding Number: Singapore Heart Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on APN-led Telemedicine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe