NCT02483494

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

July 8, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

June 23, 2015

Last Update Submit

August 3, 2017

Conditions

Acute Myocardial InfarctionAcute Coronary Syndrome

Keywords

TelemedicineAdvanced Practice Nurse

Outcome Measures

Primary Outcomes (1)

  • Readmissions 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 Outcomes (6)

  • Readmissions Days Per 1000 follow up days

    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

  • EuroQoL

    6 months

  • +1 more secondary outcomes

Study Arms (2)

APN-led Telemedicine

EXPERIMENTAL

Participants will receive APN-led Telemedicine in addition to usual care.

Other: APN-led Telemedicine

Usual care

NO INTERVENTION

Participants will receive the standard of care which includes education by cardiac care nurses and face-to-face consultations.

Interventions

APN-led TelemedicineOTHER

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.

APN-led Telemedicine

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Kent Ridge, 117597, Singapore

RECRUITING

Related Publications (2)

  • Young W, Rewa G, Goodman SG, Jaglal SB, Cash L, Lefkowitz C, Coyte PC. Evaluation of a community-based inner-city disease management program for postmyocardial infarction patients: a randomized controlled trial. CMAJ. 2003 Oct 28;169(9):905-10.

    PMID: 14581307BACKGROUND

  • Koh KW, Wang W, Richards AM, Chan MY, Cheng KK. Effectiveness of advanced practice nurse-led telehealth on readmissions and health-related outcomes among patients with post-acute myocardial infarction: ALTRA Study Protocol. J Adv Nurs. 2016 Jun;72(6):1357-67. doi: 10.1111/jan.12933. Epub 2016 Feb 25.

    PMID: 26915719DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Karen Koh

    National University Heart Centre, Singapore

    PRINCIPAL INVESTIGATOR

  • A Mark Richards

    National University Heart Centre, Singapore

    STUDY CHAIR

  • Mark Chan

    National University Heart Centre, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Koh

CONTACT

+65 6772 6884karen_wl_koh@nuhs.edu.sg

Sock Cheng Poh

CONTACT

+65 9772 0495sock_cheng_poh@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director of Nursing

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 29, 2015

Study Start

July 8, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

August 4, 2017

Record last verified: 2017-08

Locations

SG(1)