Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000686101
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
7/05/2019
Date last updated
5/02/2021
Date data sharing statement initially provided
7/05/2019
Date results provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new smart phone app (“Smart Track”) for adults with experience of addictive behaviour(s): Exploring the experience and attitudes of SMART Recovery participants and facilitators about using the app to self-monitor progress
Scientific title
Exploring the feasibility and acceptability of Incorporating routine outcome monitoring and tailored feedback into SMART Recovery Australia mutual support groups using a novel mHealth application (‘Smart Track’)
Secondary ID [1] 297890 0
AOD Early Innovation Fund EII Application number: 207
Universal Trial Number (UTN)
U1111-1226-4228
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction 312268 0
Condition category
Condition code
Mental Health 310817 310817 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME
Routine Outcome Monitoring and Feedback Tool: Smart Track App

WHY
Routine Outcome Monitoring (ROM), or the systematic assessment of progress throughout treatment is an important mechanism for monitoring the effectiveness of service provision (Burgess, Pirkis & Coombs, 2015). ROM data can be used to generate feedback, and to help identify whether or not a client is progressing as expected, thereby allowing progress to be reinforced and / or treatment plans to be revised as needed (Lambert et al., 2005). This study is designed to measure the feasibility and acceptability of using a digital platform (a Smart Phone App called “Smart Track”) with adults attending SMART Recovery Groups in NSW for the purpose of ROM and Feedback.

Smart Track was developed by the research team during the first phase of this study using an iterative process informed by a) existing ROM tools, b) qualitative feedback from SMART Recovery participants and facilitators, c) clinical and research expertise from the members of the expert advisory and steering committees and d) the technological and creative expertise of the development team employed to work on this study (GHO, Sydney; www.ghosydney.com). App development was guided by the ‘Person-Based’ approach (Yardley et al., 2015), ‘The Behavioral Intervention Technology (BIT) Model’ (Mohr et al., 2014) and the ‘Integrate, Design, Assess, and Share (IDEAS)’ framework (Munmah et al., 2016).

WHAT: ROM Items
Smart Track has been designed to provide multidimensional assessment and feedback across the following domains: group attendance; goal setting/attainment; values; self-efficacy; quality of life; self-care; mental health; quantity, frequency and impact of addictive behaviour(s); socialsupport; financial stability; optimism and the frequency, strength and duration of urges). The proposed ROM item set included in the app is detailed in Supplementary Table 1 as a function of target domain and assessment frequency. Participants will be encouraged to complete the ROM items once per week, ideally within the 24hours preceding attendance at a SMART Recovery group. Participants will be encouraged to use the app for at least two months (i.e. for the time between baseline and 2-month follow-up assessment).

WHAT: Feedback
Participants will be presented with a summary of recent progress (written and visual) within all of the domains assessed. Based on participant responses to individual ROM items and/ or subscale scores, tailored visual cues (e.g. colours and arrows) will be used to provide a ‘snapshot’ of progress within each domain (e.g. current score range and/ or direction of progress). Participants can also select one or more domain(s) to receive more detailed feedback (written and visual). The written feedback will comprise encouraging statements, self-reflection questions and/ or self-management suggestions. Visual feedback will consist of a graph illustrating participant progress over time.

WHAT: Additional features
Inconsistent engagement (patient and/ or clinician) has long been identified as a challenge to both ROM and feedback (e.g.Duncan and Murray, 2012) and the mHealth literature (e.g. Berrouiguet et al., 2016) more broadly. Therefore, in addition to the core ROM and feedback functionality, several additional features have been included with a view to enhance engagement including: customisable support(s) and personal motivation(s); helpful resources; self-management tips and motivational statements; self-reflection entries and an interactive urge log (See supplementary Table 2).

WHO/ HOW
Consistent with recommendations for improving ROM uptake (Boswell et al., 2015), SMART Recovery facilitators at each study site will assume the role of ‘local champions’ of Smart Track. The research team will work with facilitators to orient them to the app, such that they are confident in managing day-to-day questions about ROM completion and troubleshooting any difficulties that may arise. SMART Recovery facilitators will also prompt, encourage and support study participants to regularly complete the ROM questions before and/ or after group. Research staff will also be available (remotely and/ or in-person) to orient
participants to Smart Track and (as needed) help troubleshoot difficulties associated with app use.

Smart Track will be accessible across iOS (9.0 and above) and Android (4.4 and above) platforms. A lower fidelity version will also be accessible via tablet (for those who do not have a Smart Phone, but wish to participate). Participants will be encouraged to complete the ROM items weekly across the eight week duration of the study. However, it is ultimately up to the individual whether/ how often they access the various features of the app (i.e. consistent with aims of exploring feasibility and acceptability).

WHERE
Potential participants will use SMART Track before, after and or between SMART Recovery groups held in NSW, Australia. A full list of study sites will be reported in the outcomes paper. SMART Recovery groups are held in the community as well as inpatient, outpatient and clinical health organisations including private, public and not for profit mental health, drug and alcohol and general health services. Online meetings are also available.
Intervention code [1] 314119 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319658 0
Feasibility (composite outcome), as assessed by - the proportion of eligible participants that consent in to the study, the proportion of missing data for each of the ROM items/ instruments at each week of administration; - costs associated with developing and maintaining Smart Track until the completion of data collection (e.g. development and maintenance fees; app store fees) - participant engagement with Smart Track, as indexed by data analytics captured daily across the data collection period
Timepoint [1] 319658 0
8-week post-baseline (ROM data) and completion of data collection (cost and data analytics)
Primary outcome [2] 319659 0
Acceptability (composite outcome), as assessed by - detailed qualitative feedback from participants and facilitators regarding their experience of and satisfaction with Smart Track (one-one 30-60min semi-structured telephone interviews, audio-recorded and transcribed at 12-week follow-up) - quality ratings as assessed by participant and facilitator ratings of the uMARS (3 week follow-up) and MARS (12 week follow up), respectively and digital therapeutic alliance ratings as assessed by participant ratings of the Digital Working Alliance Inventory
Timepoint [2] 319659 0
2-week (uMARS and DWAI) and 8-week (MARS, qualitative interviews and DWAI) post-baseline
Secondary outcome [1] 369064 0
Smart Track engagement and usage patterns (composite outcome) as assessed by
- Demographic, clinical and treatment factors associated with (in)completion of Smart Track ROM items (as measured by CSRI, COMS and SURE)
- Data Analytics captured daily across the data collection period
Timepoint [1] 369064 0
Daily (analytics) and baseline and 8-week follow-up (CSRI, COMS and SURE)
Secondary outcome [2] 369065 0
Psychometric properties (Composite outcome: Internal reliability, convergent and divergent validity) of COMS and SURE items administered by Smart Track
Timepoint [2] 369065 0
Baseline, weekly and 8-week post-baseline
Secondary outcome [3] 369066 0
Participant reported progress across the 8-week period of app usage in Addictive behavior(s), as indexed by COMS (NADA, 2009) items and/ or the Screener for Substance and Behavioural Addictions (Schluter et al., 2018)
Timepoint [3] 369066 0
Baseline and 8-week post-baseline
Secondary outcome [4] 370037 0
Participant reported progress across the 8-week period of app usage in addiction recovery, as indexed by the SURE (Neale et al., 2016)
Timepoint [4] 370037 0
Baseline and 8-week post-baseline
Secondary outcome [5] 370038 0
Participant reported progress across the 8-week period of app usage in Mental health, as indexed by the Kessler Questionnaire (Kessler et al., 2002; 2003; NADA, 2009)
Timepoint [5] 370038 0
Baseline and 8-week post-baseline

Eligibility
Key inclusion criteria
Participants must be at least 18 years of age, currently participating in one or more SMART Recovery groups located within NSW, have a current email address or be willing to obtain an email address, and be able to comprehend English at a level sufficient to complete study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be eligible irrespective of self-reported computer/ smartphone literacy. No restrictions will be placed on concomitant care, including the frequency or duration of SMART Recovery group participation, or the participation in other forms of AOD treatment. Participants will only be excluded if they are unable or unwilling to provide informed consent. Exclusion criteria have been kept to a minimum to ensure the study sample is representative of people attending SMART Recovery groups.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed – no treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary Objectives
Given the primary objectives of exploring feasibility and acceptability, outcome data will primarily utilise descriptive statistics (e.g. summarising the proportion of missing data; data analytics; MARS and uMARS quality ratings). Descriptive statistics will be supplemented by the following cost and qualitative analyses.

Cost Analysis
A cost analysi s will be conducted with the assistance of the health economics unit at Hunter Medical Research Institute (HMRI), Australia. The analysis will adopt a health provider perspective; it will measure and report the cost associated with developing and maintaining Smart Track. This is policy relevant information as it estimates the resources required to translate the model of care to another location. Cost modelling will be conducted to report the direct costs of the additional resources required to develop and maintain Smart Track. The perspective adopted will be limited in the base case analysis to that of the health provider. Costs and resource use will be prospectively collected for the duration of the feasibility study and will be valued using a combination of hospital data from NSW Health, Medicare Benefits Schedule tariffs and market rates. Downstream cost savings associated with hospitalization will also be
explored.

Qualitative Evaluation

Qualitative data will be examined to inform the acceptability of Smart Track, by exploring participant and facilitator experience of the perceived usefulness of ROM and any reason(s) for non-adherence. Analysis will proceed in two ways. First, we will identify key concepts and experiences to inform the future development and/ or refinement of Smart Track content, features and/ or procedures. Second, if there is sufficient data, an inductive approach (Braun and Clarke, 2006) will be used to shed light on the ways in which individuals understand themselves and their actions (such as in the SMART recovery group). The methodology also allows for individual beliefs and experiences to be positioned within broader social, service and policy contexts, including factors such as drug treatment policy and service availability, social attitudes towards drugs and people who use them, ex-prisoners and family connections (Kellehear, 1993).

Secondary Objectives
A detailed exploration of the relationship between app use (as indexed by frequency of ROM completion, number of missing items and time to disengagement) and participant characteristics (demographic, clinical and treatment variables) will be explored using linear regression, graphic representation and (if appropriate) latent trajectory analysis.

Preliminary psychometrics for the Smart Track items will be explored via sensitivity to change, internal consistency, test-retest reliability, convergent validity and exploratory factor analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/05/2019
Actual
8/07/2019
Date of last participant enrolment
Anticipated
16/08/2019
Actual
20/09/2019
Date of last data collection
Anticipated
29/11/2019
Actual
2/12/2019
Sample size
Target
100
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13554 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 13555 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 13556 0
Bathurst Base Hospital - Bathurst
Recruitment postcode(s) [1] 26178 0
2050 - Camperdown
Recruitment postcode(s) [2] 26179 0
2139 - Concord
Recruitment postcode(s) [3] 26180 0
2795 - Bathurst
Recruitment postcode(s) [4] 26181 0
2050 - Missenden Road
Recruitment postcode(s) [5] 26182 0
2138 - Concord West
Recruitment postcode(s) [6] 26183 0
2795 - Bathurst West
Recruitment postcode(s) [7] 26184 0
2850 - Mudgee
Recruitment postcode(s) [8] 26185 0
2849 - Rylstone
Recruitment postcode(s) [9] 26186 0
2800 - Orange
Recruitment postcode(s) [10] 26187 0
2150 - Parramatta
Recruitment postcode(s) [11] 26188 0
2151 - North Parramatta
Recruitment postcode(s) [12] 26189 0
2770 - Mount Druitt
Recruitment postcode(s) [13] 26190 0
2200 - Bankstown
Recruitment postcode(s) [14] 26191 0
2010 - Darlinghurst
Recruitment postcode(s) [15] 26192 0
2061 - Kirribilli
Recruitment postcode(s) [16] 26193 0
2042 - Newtown
Recruitment postcode(s) [17] 26194 0
2217 - Kogarah
Recruitment postcode(s) [18] 26195 0
2153 - Baulkham Hills
Recruitment postcode(s) [19] 26196 0
2022 - Bondi Junction
Recruitment postcode(s) [20] 26197 0
2021 - Centennial Park
Recruitment postcode(s) [21] 26198 0
2680 - Griffith
Recruitment postcode(s) [22] 26199 0
2560 - Campbelltown
Recruitment postcode(s) [23] 26200 0
2165 - Fairfield

Funding & Sponsors
Funding source category [1] 302412 0
Government body
Name [1] 302412 0
Health Administration Corporation Represented by the NSW Ministry of Health (NSW Health Alcohol and Other Drugs Early Intervention Innovation Fund)
Country [1] 302412 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Avenue
Wollongong
NSW 2522
Country
Australia
Secondary sponsor category [1] 302307 0
Charities/Societies/Foundations
Name [1] 302307 0
SMART Recovery Australia
Address [1] 302307 0
Suite 501, Level 5,
80 William St,
Woolloomoolo o,
NSW 2011
Country [1] 302307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303081 0
The University of Wollongong and Illawarra and Shoalhaven Local Health District Health and Medical HREC
Ethics committee address [1] 303081 0
Ethics committee country [1] 303081 0
Australia
Date submitted for ethics approval [1] 303081 0
21/02/2018
Approval date [1] 303081 0
26/04/2018
Ethics approval number [1] 303081 0
2018/099

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

Contacts
Principal investigator
Name 92402 0
A/Prof Peter Kelly
Address 92402 0
School of Psychology
Northfields Avenue
University of Wollongong
NSW 2522 Australia
Country 92402 0
Australia
Phone 92402 0
+61 2 4239 2382
Fax 92402 0
+61 2 4221 4163
Email 92402 0
[email protected]
Contact person for public queries
Name 92403 0
Peter Kelly
Address 92403 0
School of Psychology
Northfields Avenue
University of Wollongong
NSW 2522 Australia
Country 92403 0
Australia
Phone 92403 0
+61 2 4239 2382
Fax 92403 0
+61 2 4221 4163
Email 92403 0
[email protected]
Contact person for scientific queries
Name 92404 0
Peter Kelly
Address 92404 0
School of Psychology
Northfields Avenue
University of Wollongong
NSW 2522 Australia
Country 92404 0
Australia
Phone 92404 0
+61 2 4239 2382
Fax 92404 0
+61 2 4221 4163
Email 92404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study and IPD is therefore unlikely to be useful beyond the current study


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility of a mobile health app for routine outcome monitoring and feedback in SMART recovery mutual support groups: Stage 1 mixed methods pilot study.2021https://dx.doi.org/10.2196/25217
N.B. These documents automatically identified may not have been verified by the study sponsor.