ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000733673

Ethics application status

Approved

Date submitted

13/06/2023

Date registered

6/07/2023

Date last updated

25/07/2024

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 – Non-Mental Health

Scientific title

Apps and Peer Support for Young People aged 16 to 30 years living with Diabetes but without identified Mental Health Conditions

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1294-3425

Trial acronym

APHLID-NMH

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1-Patients with diabetes and without 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.

There are no differences in this intervention compared to the intervention delivered to the mental health arm.

Intervention code [1]

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]

The primary outcome is psychological distress which will be assessed using the Kessler Psychological Distress Scale (K10).

Timepoint [1]

Measured at Baseline and after 6 months post-baseline

Secondary outcome [1]

HbA1c determined by pathology on blood samples collected from participants

Timepoint [1]

Measured at Baseline and after 6 months post-baseline

Secondary outcome [2]

Diabetes-related distress measured using the Problem Areas in Diabetes Scale (PAID)

Timepoint [2]

Measured at Baseline and after 6 months post-baseline

Secondary outcome [3]

Weight in kg will be measured using digital scale

Timepoint [3]

Measured at Baseline and after 6 months post-baseline

Secondary outcome [4]

Total number of hospital and/or emergency department admissions assessed using electronic medical records

Timepoint [4]

Baseline (during the six month period prior to commencing the trial) and over the six month duration of the trial

Secondary outcome [5]

Total number of hospital and/or emergency department admissions due to diabetic ketoacidosis /hyperglycaemia assessed using electronic medical records

Timepoint [5]

Baseline (during the six month period prior to commencing the trial) and over the six month duration of the trial

Secondary outcome [6]

Total number of hospital and/or emergency department admissions due to hypoglycaemia assessed using electronic medical records

Timepoint [6]

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 not 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?

Key exclusion criteria

Individuals with an identified mental health condition either through clinical records or screening, Individuals indicating a current pregnancy, without a smartphone and those 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

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

Active, not recruiting

Date of first participant enrolment

Anticipated

10/07/2023

Actual

10/07/2023

Date of last participant enrolment

Anticipated

30/06/2024

Actual

8/04/2024

Date of last data collection

Anticipated

8/10/2024

Actual

Sample size

Target

142

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

Campbelltown Hospital - Campbelltown

Recruitment hospital [2]

Liverpool Hospital - Liverpool

Recruitment hospital [3]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [4]

St George Hospital - Kogarah

Recruitment hospital [5]

Prince of Wales Hospital - Randwick

Recruitment hospital [6]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [7]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [8]

Goulburn Valley Health - Shepparton campus - Shepparton

Recruitment postcode(s) [1]

2560 - Campbelltown

Recruitment postcode(s) [2]

2170 - Liverpool

Recruitment postcode(s) [3]

2200 - Bankstown

Recruitment postcode(s) [4]

2217 - Kogarah

Recruitment postcode(s) [5]

2031 - Randwick

Recruitment postcode(s) [6]

2145 - Westmead

Recruitment postcode(s) [7]

2010 - Darlinghurst

Recruitment postcode(s) [8]

3630 - Shepparton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Industry, Science, Energy and Resources (MTP Connect-Targeted Translation Research Accelerator (TTRA) for Diabetes and Cardiovascular Disease).

Address [1]

250 Bay Street, Brighton, Victoria, 3186

Country [1]

Australia

Primary sponsor type

University

Name

Western Sydney University

Address

Locked Bag 1797, Penrith, NSW, 2751

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District HREC

Ethics committee address [1]

52 Scrivener St, Warwick Farm NSW 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2022

Approval date [1]

14/03/2023

Ethics approval number [1]

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 healthcare 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

Prof David Simmons

Address

Macarthur Clinical School, Western Sydney University
Parkside Cres, Campbelltown, NSW 2560

Country

Australia

Phone

+61 437 961 795

Fax

Da.Simmons@westernsydney.edu.au

Contact person for public queries

Name

Karen Mathews

Address

Macarthur Clinical School, Western Sydney University
Parkside Cres, Campbelltown, NSW 2560

Country

Australia

Phone

+61 412 503 003

Fax

K.Mathews@westernsydney.edu.au

Contact person for scientific queries

Name

David Simmons

Address

Macarthur Clinical School, Western Sydney University
Parkside Cres, Campbelltown, NSW 2560

Country

Australia

Phone

+61 437 961 795

Fax

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 -NMH 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@wesernsydney.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
19333	Study protocol	Da.Simmons@westernsydney.edu.au	Please contact trial PI Professor David Simmons.	386008-(Uploaded-13-06-2024-09-09-18)-Current Approved Protocol - APHLID_Protocol for APHLID-M_V4.0_31-3-23_ clean.docx
19334	Informed consent form	Da.Simmons@westernsydney.edu.au	Please contact trial PI Professor David Simmons.	386008-(Uploaded-13-06-2024-09-09-18)-APHLID - Master PIS and Consent form Adult_V2_clean.docx
19335	Ethical approval	Da.Simmons@wesernsydney.edu.au	Please contact trial PI Professor David Simmons.	386008-(Uploaded-13-06-2024-09-09-18)-2022ETH02515 Ethics Approval letter.pdf
23900	Informed consent form	Da.Simmons@wesernsydney.edu.au	Please contact trial PI Professor David Simmons.	386008-(Uploaded-13-06-2024-09-09-18)-APHLID - Master PIS and Consent form Minor_V2_clean.docx

Results publications and other study-related documents

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No additional documents have been identified.

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