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Trial registered on ANZCTR


Registration number
ACTRN12616001167459
Ethics application status
Approved
Date submitted
19/08/2016
Date registered
26/08/2016
Date last updated
6/02/2019
Date data sharing statement initially provided
6/02/2019
Date results information initially provided
6/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of integrated text messaging (ITM) on the efficacy of rehabilitation programs for chronic respiratory and cardiovascular disease.
Scientific title
Impact of integrated text messaging (ITM) on the efficacy of rehabilitation programs for chronic respiratory and cardiovascular disease.
Secondary ID [1] 289998 0
nil known
Universal Trial Number (UTN)
Trial acronym
The ITM study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 299056 0
chronic obstructive pulmonary disease 299057 0
Condition category
Condition code
Cardiovascular 299096 299096 0 0
Coronary heart disease
Respiratory 299097 299097 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Text messaging program will be implemented in addition to the current chronic disease rehabilitation programs in Sydney LHD. The semi-personalised messages (messages will include the participant's nickname), are sent 5 times per week, are based on behavioural psychology and provide self-management support relating to medication adherence, attendance at chronic disease programs, follow-up appointments and lifestyle change for six months. The message will contain information about smoking, diet, exercise and general info on the chronic disease the participant has been diagnosed with. The messaging program will be delivered according to our previously published model. Semi-personalised messages will be sent from a centralised web-based platform that provides simple registration and automated message delivery. Messaging software will be used to monitor whether participants open the messages or not.
Intervention code [1] 294981 0
Treatment: Other
Comparator / control treatment
Allocated participants will participate in usual care (chronic disease management program) without the text messages
Control group
Active

Outcomes
Primary outcome [1] 298564 0
Exercise capacity, 6 minute walking distance
Timepoint [1] 298564 0
6 months
Secondary outcome [1] 324586 0
The percentage of participants attending and completing a chronic disease management program. Data will be retrieved from attendance records.
Timepoint [1] 324586 0
6 months post randomisation
Secondary outcome [2] 324587 0
Medication adherence assessed by a number of questions regarding medication adherence.
Timepoint [2] 324587 0
6 months post randomisation
Secondary outcome [3] 324588 0
Quality of life using the SF-12
Timepoint [3] 324588 0
6 months post randomisation
Secondary outcome [4] 324589 0
Lifestyle change assessed through a number of questions in the case report form
Timepoint [4] 324589 0
6 months post randomisation
Secondary outcome [5] 324590 0
Hospital readmissions assessed through patient information and medical records
Timepoint [5] 324590 0
6 months
Secondary outcome [6] 344206 0
Wellbeing measured using the - COPD Assessment Test (participants with respiratory disease only).
Timepoint [6] 344206 0
6 months
Secondary outcome [7] 344207 0
Depression and anxiety - Hospital Anxiety and Depression Scale.
Timepoint [7] 344207 0
6 months

Eligibility
Key inclusion criteria
1. Have a medical history of CVD including: coronary heart disease (CHD), cardiomyopathy, peripheral arterial disease, stroke and/or history of chronic respiratory disease including: COPD, chronic bronchitis, emphysema, chronic asthma and bronchiectasis.
2. Working mobile able to receive text messages
3. Scheduled to begin rehabilitation program within 2 months of the cardiac event for patients with cardiac disease.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient understanding of English to understand the text messages

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Single blinded, participants will know if they receive text messages, however they are encouraged not to inform the staff at the rehabilitation clinic.
Allocation is concealed as it is done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur via a computer randomised program, allocation sequence will be in a 3:1 allocation ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5920 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 5921 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 5922 0
Balmain Hospital - Balmain
Recruitment hospital [4] 5923 0
Canterbury Hospital - Campsie
Recruitment hospital [5] 10354 0
Westmead Hospital - Westmead
Recruitment hospital [6] 10355 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 13368 0
2041 - Balmain
Recruitment postcode(s) [2] 13370 0
2050 - Camperdown
Recruitment postcode(s) [3] 22025 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [4] 13369 0
2139 - Concord Repatriation Hospital
Recruitment postcode(s) [5] 22026 0
2145 - Westmead
Recruitment postcode(s) [6] 13371 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 293771 0
Charities/Societies/Foundations
Name [1] 293771 0
Heart Foundation
Address [1] 293771 0
Level 12 500 Collins Street
Melbourne VIC 3000
Country [1] 293771 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 292599 0
Hospital
Name [1] 292599 0
Royal Prince Alfred Hospital
Address [1] 292599 0
Level 11 KGV Building
Missenden Road
Camperdown NSW 2050
Country [1] 292599 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295207 0
Sydney Local District Health Ethics Review Committee
Ethics committee address [1] 295207 0
Missenden Rd
Camperdown
NSW 2050
Ethics committee country [1] 295207 0
Australia
Date submitted for ethics approval [1] 295207 0
27/06/2016
Approval date [1] 295207 0
13/09/2016
Ethics approval number [1] 295207 0
X16-0283

Summary
Brief summary
Over 7 million Australians are living with a chronic conditions that cause more than half of all preventable hospital admissions. Once people leave hospital only about 50% adhere to prescribed medicines and at best 30% achieve lifestyle change. Simple strategies to improve ‘out-of-hospital’ management and support are needed. Text messaging has been shown to be effective and simple and is supported by quantitative and qualitative evidence led by CIs who have developed text message programs that promote lifestyle change. At the same time, Sydney Local Health District (LHD) has a text message system for contacting and following-up patients with chronic disease. However, these programs are not linked and in this research we will expand, refine and integrate our existing message programs then test and examine implementation. We propose a 3 phase project combining implementation science, a pragmatic trial, qualitative research and stakeholder engagement with appropriate ethical approval and following CONSORT guidelines. Phase 1 will see expansion of existing software and message content. Phase 2 is a pragmatic randomised implementation trial (n=310) with clinical and cost-effectiveness outcomes coupled with a process evaluation to inform scalability and implementation across settings. Phase 3 is a post-implementation assessment of success and challenges: to enable refinement of program content and features so as to maximise future success and ensure scalability.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes
n/a

Contacts
Principal investigator
Name 66522 0
A/Prof Julie Redfern
Address 66522 0
The University at Westmead Hospital, PO Box 154 Westmead NSW 2154
Country 66522 0
Australia
Phone 66522 0
+61 (02) 8890 9214
Fax 66522 0
None
Email 66522 0
julie.redfern@sydney.edu.au
Contact person for public queries
Name 66523 0
A/Prof Julie Redfern
Address 66523 0
The University at Westmead Hospital, PO Box 154 Westmead NSW 2154
Country 66523 0
Australia
Phone 66523 0
+61 (02) 8890 9214
Fax 66523 0
None
Email 66523 0
cindy.kok@sydney.edu.au
Contact person for scientific queries
Name 66524 0
A/Prof Julie Redfern
Address 66524 0
The University at Westmead Hospital, PO Box 154 Westmead NSW 2154
Country 66524 0
Australia
Phone 66524 0
+61 (02) 8890 9214
Fax 66524 0
None
Email 66524 0
julie.redfern@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval for sharing individual patient data
What supporting documents are/will be available?
Study protocol
Informed consent form
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary