Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000424202
Ethics application status
Approved
Date submitted
21/03/2018
Date registered
23/03/2018
Date last updated
8/10/2021
Date data sharing statement initially provided
5/03/2020
Date results information initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Is user engagement of diabetes apps associated with improved self-management in type 2 diabetes?
Scientific title
Is user engagement of diabetes apps associated with improved self-management in type 2 diabetes?
Secondary ID [1] 294263 0
None
Universal Trial Number (UTN)
U1111-1208-4684
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 306948 0
Condition category
Condition code
Metabolic and Endocrine 306047 306047 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants who are randomised to the intervention group will be asked to use the "Glucose Buddy" app for two weeks. This app has been ranked as the number 1 diabetes management app for over nine years. It allows users to easily log their blood glucose levels, meals, medication and cardio activity. Users are also able to track trends in their blood sugar levels, as well as changes in insulin, blood pressure and body weight. Additionally, this app allows users to generate reports of their data, which they can email or print out and take to their healthcare providers. Participants allocated to this app group can use any of the aforementioned functions, as much as they want to over the 2-week period.
Intervention code [1] 300571 0
Behaviour
Comparator / control treatment
The participants randomised to the active control group will be asked to use the "mySugr" app. This app allows users to log and track changes in their blood glucose levels, medication, meals, insulin, body weight, blood pressure and physical activity. Users are also able to create reports of this information to take or email to their healthcare providers. This app also has a function which allows users to receive emails with articles that provide useful tips and information related to diabetes. The participants can choose how frequently they want to receive these emails (e.g. daily, every few days, once a week etc.) The participants in this app group will be able to use any of the aforementioned functions, as frequently as they desire over the 2-week period.
Control group
Active

Outcomes
Primary outcome [1] 305093 0
Self-care behaviours will be assessed using a revised version of the Summary of Diabetes Self-Care Activities (SDSCA) (Toobert, Hampson & Glasgow, 2000). This scale measures several facets of diabetes self-management including: blood glucose testing, foot care, exercise, smoking, general diet and specific diet.
Timepoint [1] 305093 0
Baseline and at completion of the 2-week intervention
Primary outcome [2] 329162 0
Feasibility metrics: recruitment uptake (determined by the duration of time it took to recruit the required sample size and number of participants who declined to participate), self-reported adherence to the diabetes apps (measured via 2 self-report questions: “In the last 14 days, on how many days did you use the app?” and “On the days that you used the app, approximately how many minutes did you spend using the app?”) and follow-up rates (determined by study records and assessing lost-to-follow up rates) were assessed as a composite primary outcome.
Timepoint [2] 329162 0
Baseline and following completion of the 2-week intervention
Secondary outcome [1] 344142 0
User engagement of the two apps will be assessed using an adapted form of the Mobile Application Rating Scale (MARS) (Stoyanov et al., 2015).
Timepoint [1] 344142 0
Following completion of the 2-week intervention
Secondary outcome [2] 344143 0
Illness beliefs will be assessed using a diabetes-specific Brief Illness Perceptions Questionnaire (Brief IPQ) (Broadbent, Petrie, Main & Weinman, 2006). This scale contains nine-items that measure cognitive and affective beliefs about illness and demonstrates good reliability and validity.
Timepoint [2] 344143 0
Baseline and at completion of the 2-week intervention
Secondary outcome [3] 344144 0
Usability and acceptability of the apps will also be assessed qualitatively by asking a subset of participants (n=3 from each group) to attend an interview or focus group about their experience using the app.
Timepoint [3] 344144 0
Following completion of the 2-week intervention

Eligibility
Key inclusion criteria
Inclusion criteria are: (1) a diagnosis of type 2 diabetes; (2) 18 years of age or older; (3) ability to speak, read and understand English and provide informed consent; (4) own an iOS or android smartphone that is capable of downloading apps.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generator
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
Pearson’s correlations will be used to explore the relationship between user engagement, demographic characteristics, disease characteristics, illness beliefs and self-care behaviours. Multiple linear regression will also be used to examine which of the variables predict selfcare behaviours.

A repeated measures ANOVA will be used to examine differences between the two groups at follow-up.

Data analysis will be performed using SPSS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/04/2018
Actual
24/04/2018
Date of last participant enrolment
Anticipated
26/06/2018
Actual
24/07/2018
Date of last data collection
Anticipated
10/07/2018
Actual
24/08/2018
Sample size
Target
90
Accrual to date
Final
89
Recruitment outside Australia
Country [1] 9665 0
New Zealand
State/province [1] 9665 0
Auckland

Funding & Sponsors
Funding source category [1] 298900 0
University
Name [1] 298900 0
The University of Auckland
Country [1] 298900 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Dept. of Psychological Medicine
University of Auckland
Private bag 92019, Victoria Street West,
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 298114 0
None
Name [1] 298114 0
Address [1] 298114 0
Country [1] 298114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299843 0
Health and Disability Ethics Committees
Ethics committee address [1] 299843 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299843 0
New Zealand
Date submitted for ethics approval [1] 299843 0
Approval date [1] 299843 0
26/02/2018
Ethics approval number [1] 299843 0
18/STH/43

Summary
Brief summary
This study seeks to investigate whether user engagement is associated with self-management in type 2 diabetes, using a pilot randomised design. We will measure adherence to self-care tasks, user engagement and illness perceptions using questionnaires.

Patients with type 2 diabetes will be randomised to trial one of two commercially available diabetes apps for two weeks. In addition, 2-3 participants from each app group will be asked to attend a focus group to assess the usability and acceptability of the apps.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81742 0
Dr Anna Serlachius
Address 81742 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 81742 0
New Zealand
Phone 81742 0
+64 09 9233073
Fax 81742 0
Email 81742 0
a.serlachius@auckland.ac.nz
Contact person for public queries
Name 81743 0
Anna Serlachius
Address 81743 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 81743 0
New Zealand
Phone 81743 0
+64 09 9233073
Fax 81743 0
Email 81743 0
a.serlachius@auckland.ac.nz
Contact person for scientific queries
Name 81744 0
Anna Serlachius
Address 81744 0
Dept. of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 81744 0
New Zealand
Phone 81744 0
+64 09 9233073
Fax 81744 0
Email 81744 0
a.serlachius@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.