Evidence map›Paper›PMID 29370829›Full record

ArticleTrials2018

Text4Heart II - improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial.

Ralph Maddison, Ralph Stewart, Rob Doughty, Tony Scott, Andrew Kerr, Jocelyne Benatar, Robyn Whittaker, Jonathan C Rawstorn, Anna Rolleston, Yannan Jiang and 4 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ralph MaddisonInstitute for Physical Activity and Nutrition, Deakin University, Geelong, VIC, Australia. ralph.maddison@deakin.edu.au.
Ralph StewartDepartment of Cardiology, Auckland District Health Board, Auckland, New Zealand.
Rob DoughtyHeart Health Research Group, Department of Medicine, University of Auckland, Auckland, New Zealand.
Tony ScottDepartment of Cardiology, Waitemata District Health Board, Auckland, New Zealand.
Andrew KerrEpidemiology and Biostatistics, University of Auckland, Auckland, New Zealand.
Jocelyne BenatarDepartment of Cardiology, Auckland District Health Board, Auckland, New Zealand.
Robyn WhittakerNational Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.
Jonathan C RawstornInstitute for Physical Activity and Nutrition, Deakin University, Geelong, VIC, Australia.
Anna RollestonThe Centre for Health, Tauranga, New Zealand.
Yannan JiangNational Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.
Paul EstabrooksDepartment of Health Promotion, Social and Behavioral Health, University of Nebraska Medical Centre, Omaha, NE, USA.
Rachel Karen SullivanDepartment of Exercise Sciences, Faculty of Science, University of Auckland, Auckland, New Zealand.
Hannah BartleyNational Institute for Health Innovation, School of Population Health, University of Auckland, Auckland, New Zealand.
Leila Pfaeffli DaleSchool of Kinesiology, University of British Columbia, Vancouver, BC, Canada.

Funding

Tracking and Evaluation CoreU54GM115458 · NIGMS · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI RIZZO, MATTHEW · 2016 to 2025
$42.8M
Health Research Council of New Zealand 15/667National Heart Foundation of New Zealand 1684NIGMS NIH HHS U54 GM115458
6 · The paper itself

Abstract

backgroundCardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand.

methodsText4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention. DISCUSSION: The Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention.

trial registrationAustralian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426 . Registered retrospectively on 1 April 2016.

Indexed as

Medication AdherenceReminder SystemsText MessagingCardiac RehabilitationCardiovascular AgentsCost-Benefit AnalysisEquivalence Trials as TopicHealth BehaviorHealth Care CostsHeart DiseasesHumansMulticenter Studies as TopicNew ZealandRandomized Controlled Trials as TopicRisk Reduction BehaviorSelf CareCardiovascular AgentsCardiovascular diseaseRisk factorsSelf-managementText messaging

Identifiers

PMID29370829
PMCPMC5785898

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.