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Acute Myocardial InfarctionALTRANCT02483494

Effectiveness of Advanced Practice Nurse-Led Telehealth on Readmissions

A study testing APN-led Telemedicine in people with Acute Myocardial Infarction and Acute Coronary Syndrome, run by National University Heart Centre, Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 85 years
What is being tested?
APN-led Telemedicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteSingapore
Study dates
8 Jul 2015to 30 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Karen Koh contact

+65 6772 6884

karen_wl_koh@nuhs.edu.sg

Sock Cheng Poh contact

+65 9772 0495

sock_cheng_poh@nuhs.edu.sg

Singapore1 site, 1 recruiting

  • National University Hospital

    Kent Ridge, 117597

    Karen WL Koh, 67726884, karen_wl_koh@nuhs.edu.sg

    Sock Cheng A Poh, sock_cheng_poh@nuhs.edu.sg

    Recruiting

Other trials in Singapore

About this study

Official title: 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.

Read the 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.

Being tested
APN-led Telemedicine
Keywords
Telemedicine, Advanced Practice Nurse
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02483494
Study groupRoleWhat they receive
APN-led TelemedicineExperimentalParticipants will receive APN-led Telemedicine in addition to usual care.
Receives: Other: APN-led Telemedicine
Usual careNo interventionParticipants will receive the standard of care which includes education by cardiac care nurses and face-to-face consultations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 30 days

Secondary outcomes (6)

  1. Readmissions Days Per 1000 follow up days

    Cardiac and non-cardiac causes

    Measured: 6 months

  2. ED visits or unplanned self-reported doctor visits

    Cardiac and non-cardiac causes

    Measured: 6 months

  3. Cardiac Self-Efficacy Scale

    Health Related Outcomes

    Measured: 6 months

  4. Myocardial Infarction Dimension Assessment Scale

    Health Related Outcomes

    Measured: 6 months

  5. EuroQoL

    Health Related Outcomes

    Measured: 6 months

  6. Hospital Anxiety and Depression Scale

    Health Related Outcomes

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2015 (estimated)
  2. Study start8 Jul 2015
  3. Primary completion30 Jun 2018 (estimated)
  4. Study completion30 Jun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02483494
Sponsor's protocol ID
2014\00793
Other IDs
RG2013/03, 2014
Acronym
ALTRA
Status last verified
Aug 2017
First submitted
23 Jun 2015
Last updated
4 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 14581307

  • 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.

    PubMed 26915719

Questions about this trial

What is this clinical trial studying?

A study testing APN-led Telemedicine in people with Acute Myocardial Infarction and Acute Coronary Syndrome, run by National University Heart Centre, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karen Koh (+65 6772 6884, karen_wl_koh@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Readmissions Days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02483494, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.

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