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Trial registered on ANZCTR


Registration number
ACTRN12613000901707
Ethics application status
Approved
Date submitted
9/08/2013
Date registered
13/08/2013
Date last updated
3/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Text4Heart: A text message and Internet-based comprehensive cardiac rehabilitation intervention
Scientific title
A randomised controlled trial to determine the efficacy of a text message and Internet-based comprehensive cardiac rehabilitation programme to improve adherence to lifestyle change compared with usual care in New Zealand adults with a diagnosis of cardiovascular disease.
Secondary ID [1] 282996 0
None
Universal Trial Number (UTN)
U1111-1138-4525
Trial acronym
Text4Heart
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 289823 0
Condition category
Condition code
Cardiovascular 290177 290177 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 290178 290178 0 0
Other physical medicine / rehabilitation
Public Health 290179 290179 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a mHealth comprehensive cardiac rehabilitation (CR) programme. All intervention participants will receive a tailored programme of text messages (SMS) via their mobile phone with evidence-based information on actions that will reduce risk of subsequent events (e.g., education about risk factors, the impact changes can have on their risk, the importance of taking CVD medications, improving diet and exercise, reducing stress, and getting help for stopping smoking).

Each participant in the intervention group will receive at minimum the basic CR program, consisting of 5 messages per week for 6 months. These will be sent at times to suit participants and will be personalised (including participant’s name). Participants can request extra messages on one behaviour they would like to focus on (physical activity, healthy eating, stopping smoking, or reducing stress), which would result in an additional 3 messages per week over the first 12 weeks. The intervention will be predominantly unidirectional but participants will be able to ‘text an expert’ about lifestyle change, with questions answered within 24 hours. Participants will also be asked to text in their pedometer step counts and will receive a tailored response.

Participants will also have access to an interactive website which contains a blog, a graph of their physical activity progress, role model video messages, and weekly healthy lifestyle tips.
Intervention code [1] 287710 0
Behaviour
Intervention code [2] 287720 0
Rehabilitation
Intervention code [3] 287721 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 290208 0
Adherence to lifestyle behaviour change, measured using a composite health behaviour score. Participants are assigned one point for each positive health behaviour, including current non-smoking, not physically inactive, moderate alcohol intake, and fruit and vegetable intake of at least 5 servings a day. Absence of the respective behaviours equates to a zero, thus scores range from 0-4.
Timepoint [1] 290208 0
Baseline and 24 weeks
Secondary outcome [1] 304105 0
Difference in absolute CVD risk score
Timepoint [1] 304105 0
Baseline and 24 weeks
Secondary outcome [2] 304107 0
Illness perceptions (B-IPQ)
Timepoint [2] 304107 0
Baseline and 24 weeks
Secondary outcome [3] 304108 0
Self-efficacy for Managing Chronic Disease (Stanford Self-Efficacy for Managing Chronic Disease 6-item scale)
Timepoint [3] 304108 0
Baseline and 24 weeks
Secondary outcome [4] 304109 0
Medication adherence (Morisky 8-item)
Timepoint [4] 304109 0
24 weeks
Secondary outcome [5] 304142 0
Mood (Hospital Anxiety and Depression Scale)
Timepoint [5] 304142 0
Baseline and 24 weeks

Eligibility
Key inclusion criteria
1. A clinically documented diagnosis of ischaemic heart disease (myocardial infarction, angina, revascularisation) within the previous 3 weeks
2. eligible for cardiac rehabilitation
3. have access to the Internet (participants will be provided with a basic mobile phone if needed)
Minimum age
18 Years
Maximum age
No limit
Sex
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 less than 1 year, and significant exercise limitations other than CVD.

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)
Eligible participants will be identified by research nurses from two participating hospitals in Auckland. Potential participants will be identified during hospital admission for IHD. They will be informed about the study prior to discharge and asked if they wish to participate or would like more information. Those not interested in participating will be offered usual CR care. The research nurses will forward the contact details of interested potential participants to the study team, who will then contact the potential participant to explain the study and book their baseline assessment.

Following baseline assessment procedures, participants will be randomly assigned to either the mHealth intervention or usual care control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a computer generated sequence, with allocation concealed in consecutively numbered sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2013
Actual
17/05/2013
Date of last participant enrolment
Anticipated
Actual
28/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
123
Recruitment outside Australia
Country [1] 5287 0
New Zealand
State/province [1] 5287 0

Funding & Sponsors
Funding source category [1] 287765 0
Government body
Name [1] 287765 0
National Institute for Health Innovation, The University of Auckland
Country [1] 287765 0
New Zealand
Primary sponsor type
Individual
Name
Leila Pfaeffli
Address
National Institute for Health Innovation
University of Auckland
Private Bag 92019, Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286490 0
None
Name [1] 286490 0
Address [1] 286490 0
Country [1] 286490 0
Other collaborator category [1] 277572 0
Hospital
Name [1] 277572 0
Auckland City Hospital
Address [1] 277572 0
2 Park Road
Grafton 1010
Auckland
Country [1] 277572 0
New Zealand
Other collaborator category [2] 277573 0
Hospital
Name [2] 277573 0
North Shore Hospital
Address [2] 277573 0
124 Shakespeare Rd
Westlake 0622
Auckland
Country [2] 277573 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289712 0
Health and Disability Ethics Committee
Ethics committee address [1] 289712 0
Ethics committee country [1] 289712 0
New Zealand
Date submitted for ethics approval [1] 289712 0
22/01/2013
Approval date [1] 289712 0
16/05/2013
Ethics approval number [1] 289712 0
13/NTA/6/AM01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42090 0
Ms Leila Pfaeffli
Address 42090 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 42090 0
New Zealand
Phone 42090 0
+64 9 923 4728
Fax 42090 0
Email 42090 0
l.pfaeffli@nihi.auckland.ac.nz
Contact person for public queries
Name 42091 0
Leila Pfaeffli
Address 42091 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 42091 0
New Zealand
Phone 42091 0
+64 9 923 4728
Fax 42091 0
Email 42091 0
l.pfaeffli@nihi.auckland.ac.nz
Contact person for scientific queries
Name 42092 0
Leila Pfaeffli
Address 42092 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 42092 0
New Zealand
Phone 42092 0
+64 9 923 4728
Fax 42092 0
Email 42092 0
l.pfaeffli@nihi.auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseText Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial.2015https://dx.doi.org/10.2196/jmir.4944
N.B. These documents automatically identified may not have been verified by the study sponsor.