Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000200987
Ethics application status
Approved
Date submitted
7/02/2020
Date registered
20/02/2020
Date last updated
9/01/2023
Date data sharing statement initially provided
20/02/2020
Date results information initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot testing a brief values-guided intervention for diabetes among young people with Type 1 diabetes
Scientific title
Effect of a novel values-guided intervention on glucose management adherence among adolescents and young adults with Type 1 diabetes: Pilot study
Secondary ID [1] 300437 0
Nil known
Universal Trial Number (UTN)
U1111-1247-4196
Trial acronym
BIFID (Brief Intervention for Improving Diabetes)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 316094 0
Condition category
Condition code
Metabolic and Endocrine 314384 314384 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The brief intervention for improving diabetes (BIFID) aims to motivate sustainable behaviour change by connecting self-management with self-chosen values. The intervention will follow a protocol to achieve key tasks: 1) identify the participant’s values, 2) identify how diabetes has been a barrier to valued living, 3) provide education on coping with diabetes-specific barriers to valued living, 4) create an action plan to change one diabetes-specific behaviour. The education on coping strategies and the action plan will be tailored to the individual based on their self-reported barriers. Participants may receive one or more single-paged handouts to reinforce how to practice a new coping strategy. Handouts will be selected from the Acceptance and Commitment Therapy literature (e.g., Harris https://www.actmindfully.com.au/free-stuff/worksheets-handouts-book-chapters/;
Hayes & Ciarrochi https://thrivingadolescent.com/adolescent-resources/thriving-adolescent-book-downloads/). Adherence to the action plan will be assessed at the 4-week post-intervention study visit.

The intervention will be delivered in a single 30 to 60-minute session face-to-face (e.g., clinical setting, participant’s home) or via teleconference by a health practitioner (medical doctor) or health researcher. The individual delivering the intervention will have knowledge of type 1 diabetes management and training in Acceptance and Commitment Therapy.
Intervention code [1] 316772 0
Lifestyle
Intervention code [2] 316773 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322777 0
Change in the proportion of time in range (3.9 to 10.0 mmol/L) as measured by FreeStyle Libre Pro interstitial glucose monitoring system
Timepoint [1] 322777 0
For up to 14 days immediately prior to the baseline (intervention) visit and for up to 14 days beginning 2 weeks from the baseline visit
Secondary outcome [1] 379699 0
Change in self-management as measured by the SElf-Care Inventory-Revised.
Timepoint [1] 379699 0
2 weeks prior to the baseline (intervention) visit and 4 weeks post-intervention
Secondary outcome [2] 379700 0
Change in glucose monitoring frequency, as measured by a personal glucose monitoring device.
Timepoint [2] 379700 0
2 weeks prior to the baseline (intervention) visit and 4 weeks post-intervention
Secondary outcome [3] 379701 0
Change in diabetes distress as measured by the Diabetes Distress Screening Scale.
Timepoint [3] 379701 0
2 weeks prior to the baseline (intervention) visit and 4 weeks post-intervention
Secondary outcome [4] 379704 0
Change in diabetes-specific acceptance as measured by the Diabetes Acceptance and Action Scale-Revised.
Timepoint [4] 379704 0
2 weeks prior to the baseline (intervention) visit and 4 weeks post-intervention
Secondary outcome [5] 379705 0
Change in psychological flexibility as measured by the CompACT questionnaire.
Timepoint [5] 379705 0
2 weeks prior to the baseline (intervention) visit and 4 weeks post-intervention
Secondary outcome [6] 379706 0
Change in HbA1c as measured by a point of care device and as recorded in patient medical records. HbA1c is routinely measured every 3 months as part of standard care.
Timepoint [6] 379706 0
Pre-intervention and 3 months post-intervention

Eligibility
Key inclusion criteria
1. Diagnosed with type 1 diabetes for at least 6 months
2. Most recent HbA1c is at least 58 mmol/mol
3. English fluency
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any severe uncontrolled comorbidities
2. Participation in a study that may affect glucose levels

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The pilot study sample size determination was based on a pragmatic approach where 20 participants was deemed sufficient to explore the impact of the intervention on glycaemic control to determine if future research is warranted and identify issues that could impact a future RCT. As this is a pilot study, our aim is to estimate the mean and standard deviation (SD) of the change in the percentage of time in the target range of 3.9-10 mmol/L (70-180 mg/dL). It is not our aim to detect a change to a level of statistical significance.

Within-person differences between pre- and post-intervention will be determined for all primary and secondary measures. These differences will be plotted (histograms and box plots), and described using appropriate descriptive statistics (e.g. mean or median, SD, and ranges). All analyses will be undertaken using Stata 16.0 (StataCorp, Texas) by a biostatistician.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2020
Actual
20/10/2020
Date of last participant enrolment
Anticipated
1/11/2022
Actual
11/08/2022
Date of last data collection
Anticipated
31/12/2022
Actual
13/08/2022
Sample size
Target
20
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 22339 0
New Zealand
State/province [1] 22339 0
Otago

Funding & Sponsors
Funding source category [1] 304853 0
Charities/Societies/Foundations
Name [1] 304853 0
Healthcare Otago Charitable Trust
Country [1] 304853 0
New Zealand
Primary sponsor type
University
Name
Department of Women's and Children's Health, University of Otago
Address
PO Box 56, Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 305193 0
None
Name [1] 305193 0
Address [1] 305193 0
Country [1] 305193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305265 0
Health and Disability Ethics Committee
Ethics committee address [1] 305265 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 305265 0
New Zealand
Date submitted for ethics approval [1] 305265 0
30/01/2020
Approval date [1] 305265 0
01/04/2020
Ethics approval number [1] 305265 0
Ethics ref: 20/STH/23

Summary
Brief summary
The aim of the research is to test a values-guided diabetes self-management intervention for adolescents and young adults with type 1 diabetes (T1D). The single-arm pilot study (n=20) will quantify the impact of the intervention on short-term glycaemic control (i.e., time in range, 3.9-10.0 mmol/L). We will recruit patients ages 18-25 years with a T1D diagnosis and under the care of Southern District Health Board diabetes services.

It is hypothesized that time in range will increase from pre- to post-intervention, but there is not enough previous research to hypothesize a percentage increase.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99814 0
Dr Sara Styles
Address 99814 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 99814 0
New Zealand
Phone 99814 0
+64 03 479 7946
Fax 99814 0
Email 99814 0
[email protected]
Contact person for public queries
Name 99815 0
Dr Sara Styles
Address 99815 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 99815 0
New Zealand
Phone 99815 0
+64 03 479 7946
Fax 99815 0
Email 99815 0
[email protected]
Contact person for scientific queries
Name 99816 0
Dr Sara Styles
Address 99816 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 99816 0
New Zealand
Phone 99816 0
+64 03 479 7946
Fax 99816 0
Email 99816 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
Due to the small study size, individuals may be identifiable and therefore IPD will not be publicly available.


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.