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Trial registered on ANZCTR


Registration number
ACTRN12623000734662
Ethics application status
Approved
Date submitted
13/06/2023
Date registered
6/07/2023
Date last updated
6/07/2023
Date data sharing statement initially provided
6/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Apps and Peer support for a Healthy future and Living Well with Diabetes – Mental Health
Scientific title
Apps and Peer Support for Young People aged 16 to 30 years living with Diabetes and Mental Health Conditions
Secondary ID [1] 309472 0
Nil known
Universal Trial Number (UTN)
U1111-1285-3967
Trial acronym
APHLID-M
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 329734 0
Mental Health 329735 0
Condition category
Condition code
Metabolic and Endocrine 326632 326632 0 0
Diabetes
Mental Health 326633 326633 0 0
Anxiety
Mental Health 327351 327351 0 0
Depression
Mental Health 327352 327352 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1- Patients with diabetes and a mental health (MH) condition will receive a phone application - an “App” containing diabetes and mental health resources.

The adapted App was configured in collaboration with a digital health company (Perx Health) using an existing clinically validated digital health platform used for several conditions (eg Type 2 diabetes, cystic fibrosis). A working group of diabetes (eg credentialled diabetes educators endocrinologists) and MH (eg psychiatric and psychologist) clinicians, academics, digital health company (Perx Health) members, consumers and patient group representatives was established. A list of diabetes and MH resources and website links were identified and agreed upon using a Delphi process. The adapted Perx App constitutes the intervention and has been configured with two Health Hubs; one for participants with Type 1 diabetes and the other for those with Type 2 diabetes. The online written diabetes resources in both health hubs are available as hyperlinks within the subject headings: Glucose Management, Insulin Pumps, Injections, Sick Days, Food, Contraception and Pre-pregnancy and Living with Diabetes. Similarly, the online mental health resources are available as hyperlinks within the subject headings: Mindfulness Apps and Online Resources, Anxiety, Depression, Stress, Eating Disorders and General Mental Health. Diabetes and Mental health in the Health Hub will be available for participants to access ad libitum during the six month intervention period. Participants will also receive in-app communications every four to five days (on average) in the form of messages, alerts and tasks which will direct them to specific resources within the health hub. App analytics will be collected by Perx and include: medication and task adherence, enrolment, App utilisation (eg average sessions per day, average time spent in app per month, utilisation of diabetes and mental health resources), participant satisfaction and content engagement. Time using the app is linked to the in-app communication and is an exploratory outcome.

2- Diabetes management involves standard management through local diabetes services. Appointments lasting approximately 60 minutes are scheduled for patients to attend diabetes clinics every three months. During clinic appointments patients’ diabetes management is assessed and revised according to that assessment by both a credentialled diabetes educator and an endocrinologist. HbA1c and weight are generally measured every 3 months as part of clinical care by either point-of-care or laboratory-based methods. Attendance is recorded electronically.

All participants receiving the intervention (App) will have access to standard diabetes care through their regular clinic. This includes education sessions, food diary, self-management including blood glucose monitoring, healthy eating, regular clinic attendance with review of blood glucose monitoring and weight: these are performed by either or both the educator and/or endocrinologist. All participants will have access to Peer Support which is facilitated by patients with lived experience of diabetes and can be either through digital means (eg ad hoc Facebook communication, Zoom meetings) or 1:1 or group face to face meetings. Frequency and duration is as decided by the peers/peer support facilitators.

All participants will receive an activity tracker.
Intervention code [1] 325921 0
Behaviour
Comparator / control treatment
Diabetes management involves standard management through local diabetes services. This includes education sessions, food diary, self-management including blood glucose monitoring, healthy eating, regular clinic attendance with review of blood glucose monitoring and weight and access to Peer support. Participants will also receive an activity tracker.
Control group
Active

Outcomes
Primary outcome [1] 334532 0
The primary outcome is psychological distress which will be assessed using the Kessler Psychological Distress Scale (K10).


Timepoint [1] 334532 0
Measured at Baseline and after 6 months post-baseline
Secondary outcome [1] 422395 0
HbA1c determined by pathology on blood samples collected from participants
Timepoint [1] 422395 0
Measured at Baseline and after 6 months post-baseline
Secondary outcome [2] 422642 0
Diabetes-related distress measured using the Problem Areas in Diabetes Scale (PAID)
Timepoint [2] 422642 0
Measured at Baseline and after 6 months post-baseline
Secondary outcome [3] 422643 0
Weight in kg will be measured using digital scale
Timepoint [3] 422643 0
Measured at Baseline and after 6 months post-baseline
Secondary outcome [4] 422644 0
Total number of hospital and/or emergency department admissions assessed using electronic medical records
Timepoint [4] 422644 0
Baseline (during the six month period prior to commencing the trial) and over the six month duration of the trial
Secondary outcome [5] 422645 0
Total number of hospital and/or emergency department admissions due to diabetic ketoacidosis /hyperglycaemia assessed using electronic medical records
Timepoint [5] 422645 0
Baseline (during the six month period prior to commencing the trial) and over the six month duration of the trial
Secondary outcome [6] 422789 0
Total number of hospital and/or emergency department admissions due to hypoglycaemia assessed using electronic medical records
Timepoint [6] 422789 0
Baseline (during the six month period prior to commencing the trial) and over the six month duration of the trial

Eligibility
Key inclusion criteria
Adolescents and young adults with type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) or rare forms of diabetes, aged 16–30 years, identified as having a mental health condition and willing to give written/online informed consent. The participants must be familiar with and possess a smartphone (either Apple or android operating systems) that is compatible with the App
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals indicating a current pregnancy, without a smartphone and those who are unable to provide written/online informed consent will be ineligible to participate in the study. As the App is in English those who cannot converse effectively in English will also be excluded from study participation.

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)
Allocation will be concealed from the researcher determining participant eligibility and collecting baseline data as allocation occurs after questionnaires are completed and after baseline data is collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation numbers will be allocated by the database randomiser using a block randomisation approach. The details of participants who are randomised for the App intervention will be added to the Perx portal. Perx will onboard all patients via emails and SMS notifications which will contain details on how to download the modified Perx App and sign-in to their device.
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 data published previously (behavioural intervention K10 change 21.2 ± 9.4 vs baseline 25.7 ± 9.7 Cohen d =0.5), a sample size of 64 per group in the primary RCT will be required to identify a moderate effect size of 0.5 between intervention and control groups, in a t test model with power=0.8, alpha 0.05. An additional 14 participants will be included to allow for an attrition rate of 10% (total n=142). A full statistical analysis plan is to be provided.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 24563 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 24564 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 24565 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [4] 24566 0
St George Hospital - Kogarah
Recruitment hospital [5] 24567 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 24568 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 24569 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 24570 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment postcode(s) [1] 40166 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 40164 0
2031 - Randwick
Recruitment postcode(s) [3] 40165 0
2145 - Westmead
Recruitment postcode(s) [4] 40161 0
2170 - Liverpool
Recruitment postcode(s) [5] 40162 0
2200 - Bankstown
Recruitment postcode(s) [6] 40163 0
2217 - Kogarah
Recruitment postcode(s) [7] 40160 0
2560 - Campbelltown
Recruitment postcode(s) [8] 40167 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 313686 0
Government body
Name [1] 313686 0
Australian Government Department of Industry, Science, Energy and Resources (MTP Connect-Targeted Translation Research Accelerator (TTRA) for Diabetes and Cardiovascular Disease
Country [1] 313686 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith, NSW, 2751
Country
Australia
Secondary sponsor category [1] 315944 0
None
Name [1] 315944 0
Address [1] 315944 0
Country [1] 315944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312833 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 312833 0
52 Scrivener St, Warwick Farm NSW 2170
Ethics committee country [1] 312833 0
Australia
Date submitted for ethics approval [1] 312833 0
28/11/2022
Approval date [1] 312833 0
14/03/2023
Ethics approval number [1] 312833 0
2022/PID02828 2022/ETH02515

Summary
Brief summary
Overall, 40-60% of youth with Type 1 or Type 2 diabetes have a mental health condition, affecting their lives, ability to self-manage their diabetes and increasing their risk of complications. Limited access to mental health services aggravates the situation. Our project addresses this through a technology-enabled model of care, leveraging access to peer support and a clinically-validated digital platform. A 6-month randomised controlled trial will rigorously test how well this model works in the ‘real world’ across eight hospitals in improving young people’s mental health (particularly distress), well-being and physical health (eg blood glucose), and reducing health care costs and burden.
Trial website
https://www.westernsydney.edu.au/aphlid
Trial related presentations / publications
Public notes
This trial was established to help address the mental health needs of young adults with diabetes identified in our retrospective cohort studies.

Gupta, A., Taylor, F., O'Sullivan, T. and Simmons, D. (2019), Characteristics of young adults with multiple episodes of diabetic ketoacidosis. Intern Med J, 49: 911-914. https://doi.org/10.1111/imj.14347. PMID: 31295788

Sritharan A, Osuagwu UL, Ratnaweera M, Simmons D. Eight-Year Retrospective Study of Young Adults in a Diabetes Transition Clinic. Int J Environ Res Public Health. 2021 Dec 1;18(23):12667. doi: 10.3390/ijerph182312667. PMID: 34886392;

Contacts
Principal investigator
Name 126082 0
Prof David Simmons
Address 126082 0
Macarthur Clinical School,
Western Sydney University
Parkside Cres, Campbelltown, NSW 2560
Country 126082 0
Australia
Phone 126082 0
+61 437961795
Fax 126082 0
Email 126082 0
Da.Simmons@westernsydney.edu.au
Contact person for public queries
Name 126083 0
Dr Karen Mathews
Address 126083 0
Macarthur Clinical School,
Western Sydney University
Parkside Cres, Campbelltown, NSW 2560
Country 126083 0
Australia
Phone 126083 0
+61 412503003
Fax 126083 0
Email 126083 0
K.Mathews@westernsydney.edu.au
Contact person for scientific queries
Name 126084 0
Prof David Simmons
Address 126084 0
Macarthur Clinical School,
Western Sydney University
Parkside Cres, Campbelltown, NSW 2560
Country 126084 0
Australia
Phone 126084 0
+61 437961795
Fax 126084 0
Email 126084 0
Da.Simmons@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data and data dictionary will be shared on reasonable request.
When will data be available (start and end dates)?
31/7/25 - 31/7/28
Available to whom?
The data will be available to genuine researchers identified through the APHLID -M Chief Investigator Group Review
Available for what types of analyses?
Statistical
How or where can data be obtained?
Data may be requested by contacting Professor David Simmons. Da.Simmons@westernsydney.edu.au


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19272Ethical approval  Da.Simmons@westernsydney.edu.au Please contact trial PI Professor David Simmons.
19273Informed consent form  Da.Simmons@westernsydney.edu.au Please contact trial PI Professor David Simmons.
19274Study protocol  Da.Simmons@westernsydney.edu.au Please contact trial PI Professor David Simmons.


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19272Ethical approval  Da.Simmons@westernsydney.edu.au Please contact trial PI Professor David Simmons. 385756-(Uploaded-13-06-2024-08-58-27)-2022ETH02515 Ethics Approval letter.pdf
19273Informed consent form  Da.Simmons@westernsydney.edu.au Please contact trial PI Professor David Simmons. 385756-(Uploaded-13-06-2024-08-51-35)-APHLID - Master PIS and Consent form Adult_V3.0_31-3-23_clean.docx
19274Study protocol  Da.Simmons@westernsydney.edu.au Please contact trial PI Professor David Simmons. 385756-(Uploaded-13-06-2024-08-51-35)-Current Approved Protocol - APHLID_Protocol for APHLID-M_V4.0_31-3-23_ clean.docx
23899Informed consent form  Da.Simmons@westernsydney.edu.au Please contact trial PI Professor David Simmons. 385756-(Uploaded-13-06-2024-08-58-27)-APHLID - Master PIS and Consent form Minor_V3.0_31-3-23_clean.docx

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.