Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000673347
Ethics application status
Approved
Date submitted
20/04/2017
Date registered
10/05/2017
Date last updated
28/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
ADEPT - Supporting Smokers to Remain Abstinent After Hospital Discharge using an Automated Digital Support Package
Scientific title
ADEPT - Supporting Smokers to Remain Abstinent After Hospital Discharge using an Automated Digital Support Package
Secondary ID [1] 291739 0
Nil Known
Universal Trial Number (UTN)
U1111-1194-7785
Trial acronym
ADEPT (automated package of digital therapies)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smokers
 302944 0
Condition category
Condition code
Public Health 302415 302415 0 0
Health service research
Mental Health 302430 302430 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to usual care, the ADEPT intervention group will receive smoking cessation support delivered using mobile phones daily over 4 weeks post-discharge. The intervention ADEPT - an automated package of digital therapies, comprise of text messages that provides motivational and distraction messages, medication [e.g. NRT] reminders and referral to Quitline or GP if desired. All intervention participants will receive a tailored programme of text messages (SMS) via their mobile phone with evidence-based information on interventions/actions that will reduce risk of subsequent events (e.g., education about risk factors, the impact changes can have on their risk, and getting help for stopping smoking). The intervention will be delivered via SMS, because this medium is readily available to all mobile phone users, is inexpensive, and requires minimal technological ‘know how’.

Each participant in the intervention group will receive 3 messages per day for the first week after discharge from hospital, when the risk of relapse to smoking is greatest; 1 message per day for the second week; and 2-3 messages per week for the remaining two weeks. The intervention will be predominantly unidirectional. All participants will be offered brief training at enrolment on how to read a text message and how to delete or save messages. This will be delivered by the research nurse and be approximately 5 minutes in duration.
Intervention code [1] 297845 0
Lifestyle
Intervention code [2] 297846 0
Behaviour
Intervention code [3] 297847 0
Treatment: Devices
Comparator / control treatment
Participants in the control arm will receive usual care. When patients are admitted their smoking status is routinely recorded, and if they are a smoker, a health worker will give them brief advice to quit smoking and issue them a ‘quitcard’ (an exchange voucher for subsidised nicotine replacement therapy [NRT]), and refer them for support via Quitline or a hospital cessation counsellor.
Control group
Active

Outcomes
Primary outcome [1] 301821 0
Three months continuous abstinence (Russell Standard) defined as self-report of smoking not more than five cigarettes from the quit date. Sub group analysis by Maori/non-Maori will be undertaken to test for heterogeneity of effect.
Timepoint [1] 301821 0
1 month post discharge
Secondary outcome [1] 333967 0
7-day point prevalence assessed: The proportion of participants that have stopped smoking, defined as self-report of having smoked no cigarettes (not even a puff) in the past seven days, at all time points.
Timepoint [1] 333967 0
1 month post discharge
Secondary outcome [2] 333997 0
Continuous abstinence assessed at one and three months: The proportion of participants that have stopped smoking, defined as self-report of smoking not more than five cigarettes from the Quit date.
Timepoint [2] 333997 0
1 month post discharge
Secondary outcome [3] 333998 0
Participant self-report of the number of cigarettes smoked per day (or when smoking for non-daily smokers): If the participant is still smoking, all time points.
Timepoint [3] 333998 0
1 month post discharge
Secondary outcome [4] 333999 0
Participant self-report of time-to-relapse from quit date, defined as return to daily smoking (for daily smokers).
Timepoint [4] 333999 0
1 month post discharge
Secondary outcome [5] 334000 0
The physical signs and symptoms associated with withdrawal: Measured using the Mood and physical symptoms scale (MPSS)
Timepoint [5] 334000 0
1 month post discharge
Secondary outcome [6] 334001 0
Use of any other smoking cessation methods: Participants will be asked about their use of NRT, non-NRT methods of cessation such as Zyban (buproprion), clonidine, nortriptyline, varenicline, acupuncture, Quitline etc.
Timepoint [6] 334001 0
1 month post discharge
Secondary outcome [7] 334002 0
Perceptions of acceptability of the intervention through exit interviews with intervention participants.
Timepoint [7] 334002 0
1 month post discharge
Secondary outcome [8] 334003 0
Engagement of the intervention (number of messages read, and number of participant contacts to study team) through exit interviews.
Timepoint [8] 334003 0
1 month post discharge

Eligibility
Key inclusion criteria
Patients will be eligible for enrollment in the study if they are aged 18 years and over; identify on admission to hospital as being current (daily and non-daily) cigarette smokers; have a mobile phone recorded in their admission record; can understand and write English; and provide informed consent and agree to be available for follow up over the next 3 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have an unstable mental health condition or other severe ill health; have serious sensory deficits involving speech and hearing; and/or do not have ready access to a mobile phone.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following baseline data collection, eligible and consented participants will be randomised by a computer-generated sequence determined by the study statistician to either intervention or control group in a 1:1 ratio. Due to the nature of the intervention, participants will be aware of their treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by computer program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data from the trial will be entered into a database at the NIHI, and then extracted into SAS (version 9.1) for analysis. Data analyses will be carried out on an intention-to-treat basis, and will be specified a priori a statistical analysis plan prepared by the study statistician (and agreed upon by all members of the Steering Committee). No interim analyses will be undertaken.
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.
Treatment evaluation will be performed on the principle of intention to treat (ITT), using data collected from all randomised participants. Simple chi-squared analyses will be used to evaluate the main treatment effect on the proportions adherent to lifestyle change at end of the intervention period, with estimation of relative risks, 95% confidence intervals and two-sided p-values. Analysis of covariance (ANCOVA) regression model will be used to evaluate the treatment effects for continuous secondary outcome measures, adjusting for its baseline measure, age, ethnicity and other potential confounding factors (if they are statistically significant at 5% level). Survival analyses will be used to estimate time to relapse to smoking for those who are not abstinent.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/06/2017
Actual
20/06/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
22/08/2017
Date of last data collection
Anticipated
30/09/2017
Actual
22/09/2017
Sample size
Target
268
Accrual to date
Final
203
Recruitment outside Australia
Country [1] 8832 0
New Zealand
State/province [1] 8832 0

Funding & Sponsors
Funding source category [1] 296234 0
Government body
Name [1] 296234 0
Health Research Council’s Tobacco Control Research Turanga
Country [1] 296234 0
New Zealand
Primary sponsor type
University
Name
National Institute for Health Innovation, The University of Auckland
Address
National Institute for Health Innovation
Level 4, School of Population Health
Tamaki Campus
The University of Auckland
261 Morrin Road
Glen Innes
Auckland 1072
New Zealand
Country
New Zealand
Secondary sponsor category [1] 295153 0
None
Name [1] 295153 0
Address [1] 295153 0
Country [1] 295153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297473 0
HDEC
Ethics committee address [1] 297473 0
Ethics committee country [1] 297473 0
New Zealand
Date submitted for ethics approval [1] 297473 0
29/03/2017
Approval date [1] 297473 0
21/04/2017
Ethics approval number [1] 297473 0

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

Contacts
Principal investigator
Name 74158 0
Prof Chris Bullen
Address 74158 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 74158 0
New Zealand
Phone 74158 0
+64 9 373 7599 (ext 84730)
Fax 74158 0
Email 74158 0
[email protected]
Contact person for public queries
Name 74159 0
Chris Bullen
Address 74159 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 74159 0
New Zealand
Phone 74159 0
+64 9 373 7599 (ext 84730)
Fax 74159 0
Email 74159 0
[email protected]
Contact person for scientific queries
Name 74160 0
Chris Bullen
Address 74160 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 74160 0
New Zealand
Phone 74160 0
+64 9 373 7599 (ext 84730)
Fax 74160 0
Email 74160 0
[email protected]

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
No additional documents have been identified.