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Trial registered on ANZCTR


Registration number
ACTRN12624000751572
Ethics application status
Approved
Date submitted
15/04/2024
Date registered
17/06/2024
Date last updated
17/06/2024
Date data sharing statement initially provided
17/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Young Adults with Paediatric-Onset Inflammatory Bowel Disease:
Evaluating the Feasibility of an Optimal Health Wellbeing Intervention, After Transfer to Adult Health Services
Scientific title
A Pilot Study to Assess the Feasibility of an Optimal Health Wellbeing Intervention Program for Young Adults with IBD after Transfer to Adult Healthcare
Secondary ID [1] 311927 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 333545 0
Crohn's Disease 333916 0
Ulcerative Colitis 333917 0
Condition category
Condition code
Oral and Gastrointestinal 330236 330236 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 330588 330588 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Optimal Health Program for Inflammatory Bowel Diseases (OHP-IBD)
The OHP-IBD is a person-centred psychosocial intervention program which uses collaborative therapy counselling techniques to address illness self-management and enhance participant capabilities in managing their own health to improve psychological, physical and general wellbeing.

The program consists of 6 one-on-one sessions: 5 x 1-hour individual sessions and another 1-hour 'booster' session at 3 months after program completion. These sessions will be conducted at regular intervals, either weekly or fortnightly, depending on each participant’s preferences. Between-session coaching is available, if requested by participants. The program will be delivered using video conferencing technology.

In summary, session 1 will introduce participants to the Health Plans and the 6 Health Domains: physical, emotional, social, occupational, intellectual and values/spiritual. Health Plan 1 addresses daily self-care strategies. Health Plans 2 and 3 focus on managing symptoms and escalating disease activity, respectively. In session 2, participants will identify their strengths, vulnerabilities and stressors, which will be used to develop Health Plans 1 and 2. Session 3 will focus on medication-related experiences, side effects and effective use of medication. They will also cover the need for medical and social support, which will be incorporated into Health Plan 3. Session 4 will explore how understanding past health events can create proactive avenues for change. Goal setting, creative problem solving and planning around the challenges of living with IBD will also be introduced. In session 5, program learnings and Health Plans will be reviewed and updated. Well-being maintenance will also be discussed. The ‘booster session’ will be delivered 3 months later, where the Health Plans will be reviewed, updated, and achievements acknowledged.

The modular format of the program allows for cumulated learning, where each session builds on the previous one and includes optional between-session tasks such as practicing some of the self-care strategies participants developed during the sessions. Participants will receive ‘The OHP Wellbeing Open Program’ workbook, which has been specifically designed for this program as an information guide, that can be also be used for journaling program learnings.

Facilitator Training and Fidelity
The facilitator will be recruited from a professional counselling agency specialising in the delivery of the OHP intervention. The same facilitator will work with all the participants, to ensure consistent program delivery.

The facilitator will complete a 2-day OHP facilitator training workshop and also attend a 3-hour IBD specific training workshop guided by the ‘The OHP-IBD Facilitator Pack’, in the month prior to program commencement. This Pack consists of two comprehensive supplements that were developed by the primary researcher. The first is an IBD information manual and the second is a facilitator guidebook which includes recommendations on the various IBD-related issues that facilitators could explore with participants during each program session. This Pack will be introduced to the facilitators during the IBD training workshop, however, it can also be used as a self-guided resource which can be referred to throughout program duration. Additional fortnightly online training, in the form of 4 x 1-hour informal tutorial sessions with facilitator’s supervisor and the primary researcher will also be provided, to enhance the facilitator’s understanding of the complexities of participants’ illness experiences and to ensure that IBD-specific issues are adequately addressed.

Ongoing weekly supervision and session summaries will be used to monitor participants’ attendance, their progress and ensure program fidelity.
Intervention code [1] 328404 0
Behaviour
Intervention code [2] 328405 0
Lifestyle
Intervention code [3] 328406 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337972 0
To examine the feasibility of the OHP-IBD as a wellbeing program to provide support for young adults with paediatric-onset IBD, the first primary outcome was to evaluate the program acceptibility by participants.
Timepoint [1] 337972 0
At post intervention (after first five sessions) and 3 months follow up (after the booster session)
Primary outcome [2] 337973 0
The second primary outcome was to evaluate participants' perceived learnings and experiences throughout the program
Timepoint [2] 337973 0
At post intervention (after first five sessions) and 3 months follow up (after booster session)
Primary outcome [3] 337974 0
The third primary outcome was to assess the feasibility of the study design (recruitment and retention).
Timepoint [3] 337974 0
Upon conclusion of the study, participant flow through the program (eligibility, recruitement rate, session attendance and retention rate) were assessed.
Secondary outcome [1] 433965 0
To obtain preliminary indications of the program’s potential effectiveness, participant outcomes relating a number self-report measures was assessed, including:
IBD-specific Self Efficacy
Timepoint [1] 433965 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow up (after booster session)
Secondary outcome [2] 435509 0
Participant's self efficacy or confidence in their ability to manage different challenging situations.
Timepoint [2] 435509 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow up (after booster session)
Secondary outcome [3] 435510 0
Quality of Life
Timepoint [3] 435510 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).
Secondary outcome [4] 435513 0
Transition Readiness
Timepoint [4] 435513 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).
Secondary outcome [5] 435514 0
Coping
Timepoint [5] 435514 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).
Secondary outcome [6] 435515 0
Negative Emotions
Timepoint [6] 435515 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).
Secondary outcome [7] 435516 0
Illness Perceptions
Timepoint [7] 435516 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).
Secondary outcome [8] 435517 0
Medication Adherence
Timepoint [8] 435517 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).
Secondary outcome [9] 435518 0
Medication Beliefs
Timepoint [9] 435518 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).
Secondary outcome [10] 436430 0
Functional Impairment
Timepoint [10] 436430 0
Baseline, Post Intervention (after the first 5 sessions) and 3-Month follow-up (after booster session).

Eligibility
Key inclusion criteria
Criteria for inclusion:
- Attended an IBD Outpatient’s Clinic for adults
- Aged between 18 to 25 years of age
- Diagnosed with paediatric-onset IBD and transferred from a paediatric healthcare service to an adult healthcare provider
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria:
- Participants with adult onset IBD (ie diagnosed at 18 years and older)
- Paediatric patients who have not yet transferred to adult healthcare services
- Never treated in a paediatric health setting prior to attending the adult IBD clinic

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
21/10/2021
Date of last data collection
Anticipated
Actual
23/03/2022
Sample size
Target
12
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316272 0
University
Name [1] 316272 0
University of Melbourne
Country [1] 316272 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318461 0
None
Name [1] 318461 0
Address [1] 318461 0
Country [1] 318461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315092 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315092 0
Ethics committee country [1] 315092 0
Australia
Date submitted for ethics approval [1] 315092 0
24/11/2020
Approval date [1] 315092 0
10/03/2021
Ethics approval number [1] 315092 0
HREC/70094/MH-2020

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

Contacts
Principal investigator
Name 133650 0
Prof Geoffrey Hebbard
Address 133650 0
Department of Gastroenterology & Hepatology, Royal Melbourne Hospital, 300 Grattan Street, Carlton, Victoria, 3052
Country 133650 0
Australia
Phone 133650 0
+61 0415332940
Fax 133650 0
Email 133650 0
Geoff.Hebbard@mh.org.au
Contact person for public queries
Name 133651 0
Despina D. Constantinidis/Prof Geoffrey Hebbard
Address 133651 0
The University of Melbourne, Parkville, Victoria, 3052
Country 133651 0
Australia
Phone 133651 0
+61 0415332940
Fax 133651 0
Email 133651 0
d.constantinidis@student.unimelb.edu.au
Contact person for scientific queries
Name 133652 0
Despina D. Constantinidis/Prof Geoffrey Hebbard
Address 133652 0
The University of Melbourne, Parkville, Victoria, 3052
Country 133652 0
Australia
Phone 133652 0
+61 0415332940
Fax 133652 0
Email 133652 0
d.constantinidis@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data generated during and/or analysed during the current study are not publicly available nor are they available on request as these participants are potentially identifiable from information contained in the interviews. Data sharing would transgress the terms of consent signed by the participants, as well as the Human Research Ethics Committee’s approval guidelines for this research.


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.