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Trial registered on ANZCTR


Registration number
ACTRN12616000422426
Ethics application status
Approved
Date submitted
23/03/2016
Date registered
1/04/2016
Date last updated
1/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Text4Heart Partnership: a text messaging program to enhance self-management of cardiovascular disease.
Scientific title
Text messaging to enhance self-management of cardiovascular disease
Secondary ID [1] 288842 0
NIL
Universal Trial Number (UTN)
U1111-1181-1942
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndrome 298117 0
Cardiovascular disease 298118 0
Coronary heart disease 298119 0
Condition category
Condition code
Cardiovascular 298283 298283 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Text4Heart is a self-management programme involving a personalised automated package of text messages via mobile phone to increase, and maintain positive lifestyle changes, including stopping smoking, eating a heart healthy diet, engaging in regular exercise behaviour, and decreasing stress. The programme will be delivered over 24 weeks. Messages focus on providing particpants with key behaviour change strategies to initiate and maintain the respective behaviours. Additional features include prompting and support to undertake the behaviour. Intervention messages were developed according to New Zealand clinical guidelines for the management of coronary heart disease, and are based on Social Cognitive Theory principles.

Each participant in the intervention group will receive at minimum the basic heart health CR program, consisting of 5 messages per week for 6 months. The general heart health messages provide overall advice and support on undertaking lifestyle change, including, taking medication, being physically active, eating healthy, and reducing alcohol consumption. One message per week on each topic is delivered or the entire six months.

Messages are sent to participants at times that suit them and will be personalised to participant’s name (or nickname, and their sex). Participants can also choose their preferred time for receiving messages. The intervention will be predominantly unidirectional; however if participants choose to text questions to the team, these will be answered within 24 hours. Participants will be instructed that the messages are for general heart health issues and that all emergency issues should be managed as per normal procedures. All participants will be offered brief training at enrolment on how to read a text message and how to delete or save messages.

Participants will be able to request additional text messages based on the suboptimal behaviour (see below) they wish to modify (identified at their baseline assessment).

1. How to start and maintain a regular exercise program
2. How to start and maintain a heart healthy diet
3. How to reduce stress and increase relaxation
4. How to stop smoking
These modules involve 1-2 additional messages per week for 12-weeks. After 12 weeks, participants can choose an new module for the remaining 12-weeks. Each message is sent once.

Using the gateway company we will monitor the number of mesages sent and received. Particpants in the intervention group will also complete questions on adherence to the intervention (number of messages recevied and read).

The intervention is completely automated and no person delivers the intervention. However. all intervention content was developed by specialists in their respective fields with more than 5 years of experience each (including cardiology, nursing, exercise/physical activity, diet, psychology, smoking cessation). Apart from the messages, no intervention materials are provided to participants.
Intervention code [1] 294290 0
Lifestyle
Intervention code [2] 294291 0
Rehabilitation
Intervention code [3] 294292 0
Prevention
Comparator / control treatment
Participants in the control arm will be offered the standard outpatient CR programme provided by each hospital, which involves support and education provision to discharged patients, with supervised exercise offered at all three participating hospitals for those wishing to participate (Phase 2 CR usually of 6-12 weeks duration). During Phase 3 participants are encouraged to continue with their lifestyle changes and join a cardiac club. Heart Guide Aotearoa is also offered at the discretion of cardiac nurses. Given the proven effectiveness of CR, it would be unethical not to offer usual CR to all participants; therefore the Intervention arm participants will be advised that they are able to access the usual CR programme in addition to the mHealth intervention, if they wish to do so.
Control group
Active

Outcomes
Primary outcome [1] 297769 0
Proportion of participants adhering to medication at 24 weeks. The medication adherence measure in this trial will be prescription record-assessed adherence, defined as: a dispensed medication ratio of 80% for each of the classes of medications consistent with guideline recommended therapy (e.g., antiplatelet, statin, and blood pressure lowering therapy, ACE-inhibitor and or a beta blocker).
Timepoint [1] 297769 0
24 weeks post randomisation
Secondary outcome [1] 322163 0
Adherence to recommended lifestyle behaviours will be measured using a composite health behaviour score adapted from the EPIC-Norfolk Prospective Population Study.
Individual lifestyle risk factors (physical activity, fruit and vegetable consumption, smoking and alcohol intake).
Timepoint [1] 322163 0
24 weeks post randomisation
Secondary outcome [2] 322164 0
Self-report medication adherence measured using the Morisky 8-item medication adherence questionnaire
Timepoint [2] 322164 0
24 weeks post-randomisation
Secondary outcome [3] 322165 0
Participant engagement with the intervention measured via text message responses and an exit interview
Timepoint [3] 322165 0
24 weeks post randomisation
Secondary outcome [4] 322166 0
Cost-effectiveness will be assessed: The cost of delivering the intervention will be collected over the trial period., including text message service and per message costs, and health service staff time for facilitation of the programme and recruitment. Any changes in health service utilisation observed between intervention and control groups will lead to an estimation of the costs of those changes with assistance of the Waitemata District Health Board Funding Team information analysts. Health related quality of life (HRQOL) will be assessed using the EQ-5D to determine change in HRQOL and cost-effectiveness.
Timepoint [4] 322166 0
Post intervention

Eligibility
Key inclusion criteria
A documented diagnosis of an acute coronary syndrome (including myocardial infarction [MI], unstable angina) or percutaneous coronary revascularisation procedure, are 18 years or older, eligible for cardiac rehabilitation.

Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Untreated ventricular tachycardia, severe heart failure, life threatening co-existing disease with life expectancy < 1 year, and significant exercise limitations other than cardiovascular disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised via a central randomisation service accessed by computer at the time of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to either intervention or control group in a 1:1 ratio. the randomisation sequence will be generated by a computer generated sequence developed by the lead biostatistican.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on the previosu Text4Heart pilot trial, a total of 330 participants (165 per group will provide at least 80% power at the 5% level of significance (two-sided) to detect an absolute difference of 15% between the two groups, in the proportions of participants adherent to medication 6 months after randomisation (assuming a control rate of 30%). This sample size will also provide at least 80% power (p<0.05) to detect an absolute difference of 15% between groups, in the proportions of participants adherent to recommended healthy behaviour guidelines months after randomisation.

Treatment evaluations will be performed on the principle of intention-to-treat. All statistical tests will be two-sided at the 5% level of significance. For missing data on the primary outcome, we will assume non-adherence. Sensitivity analyses will be conducted if the proportion of missing data is greater than 10%.

Baseline characteristics will be summarised using descriptive statistics. Continuous variables will be described as numbers of observed and missing values, mean, standard deviation, median, minimum and maximum. Categorical variables will be described as frequencies and percentages. Results will be presented for each of the two treatment arms as well as overall. Since any differences between randomised groups at baseline could only have occurred by chance, no formal significance testing on baseline variables will be conducted.

Logistic regression will be used to evaluate the main treatment effect on the proportions adherent to medication at end of the intervention period (6 months). Similar analysis will be conducted for adherence to lifestyle risk factors. The analysis of covariance (ANCOVA) regression model will used to evaluate the treatment effect on continuous secondary outcomes, adjusting for baseline values. No interim analyses will be undertaken. All secondary analyses will be exploratory.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7734 0
New Zealand
State/province [1] 7734 0
Auckland

Funding & Sponsors
Funding source category [1] 293196 0
Government body
Name [1] 293196 0
Health Research Council
Address [1] 293196 0
Level 3, 110 Stanley St, Grafton, Auckland 1010, New Zealand
Country [1] 293196 0
New Zealand
Primary sponsor type
Individual
Name
Ralph Maddison
Address
National Institure for Health Innovation, The Unviersity of Auckland
Private Bag 92019, Wellesley Street, Auckland, 1001
Country
New Zealand
Secondary sponsor category [1] 291997 0
None
Name [1] 291997 0
Address [1] 291997 0
Country [1] 291997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294682 0
Health and Disability Ethics Committees
Ethics committee address [1] 294682 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 294682 0
New Zealand
Date submitted for ethics approval [1] 294682 0
14/12/2015
Approval date [1] 294682 0
18/01/2016
Ethics approval number [1] 294682 0
15/NTA/205

Summary
Brief summary
This is a collaborative study designed and co-ordinated jointly by independent investigators at the National Institute for Health Innovation (University of Auckland), and cardiology departments at Auckland and Waitemata District Health Boards.

Objectives: To determine the effectiveness of a comprehensive text message, comprehensive, self-management intervention (Text4Heart) for people with ACS, with the following objectives.
1. Enable improved self-management as measured by improvements in 1) medication adherence and 2) adherence to lifestyle risk factors.
2. To provide information for the DHB Funding team to inform a potential roll-out of the programme, including the optimal components of the programme and methods for scaling up and integrating into existing clinical pathways, health IT systems, and an improved model for integrated care for people with heart disease.

Duration of treatment: 24 weeks

Study design and methodology: A standard, two-arm parallel, randomised controlled trial. Participants will be randomised at a 1:1 ratio to either the Text4Health intervention group or to a usual care ‘control’ group. Those randomised to the Text4Heart self-management programme will receive a personalised automated package of text messages via mobile phone to increase, and maintain positive lifestyle changes, including stopping smoking, eating a heart healthy diet, engaging in regular exercise behaviour, and decreasing stress. The programme will be delivered over 24 weeks. The remaining participants will be directed to receive usual care, which currently involves encouragement to be physically active and an offer to attend cardiac rehabilitation. Outcomes will be assessed at baseline and 24 weeks.

Study population: Clinically stable patients diagnosed with an Acute Coronary Syndrome (ACS), which includes myocardial infarction, unstable angina, or patients who have had a percutaneous coronary revascularisation procedure.

Number of subjects; A total of 330 participants (165 per group) will be randomised.

Eligible participants will be patients with ACS (including those having had a percutaneous coronary revascularisation procedure), who are clinically stable. Previous studies have shown this cohort is able to meet these criteria.

Exclusion criteria: Untreated ventricular tachycardia, severe heart failure, life threatening co-existing disease with life expectancy < 1 year, and significant exercise limitations other than CVD.

All participants will receive usual CVD support.

The primary outcome is the proportion of participants adhering to medication at 24 weeks. The medication adherence measure in this trial will be prescription record-assessed adherence.
Seconray outcomes assess self-report adherence to lifestyle change, medication adherence, cost-effectiveness and implementation outcomes.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64650 0
Prof Ralph Maddison
Address 64650 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 64650 0
New Zealand
Phone 64650 0
+6421470710
Fax 64650 0
Email 64650 0
r.maddison@auckland.ac.nz
Contact person for public queries
Name 64651 0
Mrs Melissa Rawstron
Address 64651 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 64651 0
New Zealand
Phone 64651 0
+64220663801
Fax 64651 0
Email 64651 0
m.rawstorn@auckland.ac.nz
Contact person for scientific queries
Name 64652 0
Prof Ralph Maddison
Address 64652 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 64652 0
New Zealand
Phone 64652 0
+6421470710
Fax 64652 0
Email 64652 0
r.maddison@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results