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Trial registered on ANZCTR


Registration number
ACTRN12621000390886
Ethics application status
Approved
Date submitted
29/01/2021
Date registered
8/04/2021
Date last updated
17/03/2024
Date data sharing statement initially provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the effectiveness of a self-management programme for adolescents with a chronic illness
Scientific title
A randomised controlled trial evaluating the effectiveness of a self-management programme for adolescents with a chronic illness.
Secondary ID [1] 303094 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic illness 320519 0
Medication adherence 320520 0
Condition category
Condition code
Metabolic and Endocrine 318126 318126 0 0
Diabetes
Respiratory 318739 318739 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 318740 318740 0 0
Other inflammatory or immune system disorders
Neurological 318776 318776 0 0
Epilepsy
Oral and Gastrointestinal 318777 318777 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate the effectiveness of a modified adolescent friendly version of an adult self-management program (Flinders Program™). The study will be a two site, longitudinal, randomised controlled trial, using both quantitative and qualitative research methods and conducted within the two national university teaching paediatric hospitals of the Sydney Children’s Hospital Network in Sydney, Australia.

Intervention: Following baseline data collection and randomisation, participants in the intervention group will receive a 12 month nurse led modified version of the Flinders Program™ plus standard care. The Flinders Program™ is a validated, internationally recognised program that is designed for adults. Developed from the South Australia HealthPlus coordinated care trial at Flinders University, Adelaide, Australia. It is a structured, generic, individualized program that incorporates the use of specific standardized tools. The program involves the application of three key specific assessment tools: the Partners in Health Scale, Cue and Response Interview, and the Problems & Goals Assessment which are founded on the principals of self-management. These assessment tools provide a formal, systematic approach to assessing self-management skills and problems and support goal setting that lead to the development of a self-management care plan incorporating mutually agreed issues and goals which the participant has agreed to work towards over 6-9 months with monitoring and review on a day and time agreed between the patient and health professional.

The study design will include a baseline collection period, followed by sequential, individual randomisation to control or intervention. The intervention group and control groups will be continually recruited and exposed to the intervention plus standard care and/or standard care with baseline and follow up observations collected until target numbers achieved as per power analysis. Participants in the intervention group will receive the Flinders Program™ which will be delivered individually, using a combination of face-to-face and Telehealth sessions by members of the research team who have been trained in the delivery of the Flinders Program™. The intervention will consists of a total of 4 sessions, with an initial session (90 minutes in duration), then 3 x follow up sessions (60 minutes duration) at 3, 6 and 12 months from the initial session.
The initial face-to-face session will be undertaken in a private room in a clinic environment within a tertiary paediatric referral hospital.

Outline of initial self-management support session:
1. Introduction (5 mins)
2. Partners in Health Scale (10 mins)
3. Cue and Response Interview (25 mins)
4. Discussion to identify agreed issues for the care plan (10 mins)
5. Problems and Goals Assessment (25 mins) defines the problem/s from the adolescents perspective and clearly identifies the goal/s that they agree to work towards.
6. Complete the self-management care plan (10 mins)
7. Wrap up and identify next steps (5 mins)

Follow up sessions: Formal follow up sessions will be offered (a total of three sessions at 3, 6 and 12 months) in person, via email or Telehealth modality including PEXIP video conferencing or telephone depending on the participants preference. It is envisaged that email modality will be used to make it easier to deliver session specific questionnaires to participants prior to Telehealth or telephone sessions and it would be unlikely that the follow up session would be delivered via email interaction alone. Between the delivery of the initial session and 3 months follow up, participants will receive intensive follow up consisting of a maximum of 3 phone calls (every 3 weeks), on a date a time agreed between the nurse and the patient. On clinical experience it is anticipated that the medium duration of the follow up phone calls will be 25 minutes each. Participants will receive a booster session at 6 months to maintain engagement, monitor progress and to provide feedback and motivation to help them achieve their self-management goals. The 6 month booster session will involve participants completing the Partners in Health Scale designed specifically to measure self-management behaviours. Measures of illness control and data on planned hospital admissions will be obtained from the electronic medical records by the research team.

There is a final follow up session at 12 months. Telehealth sessions will follow the same structure as the face-to-face sessions and dependent on the goals of the participant. No educational materials will be provided to participants in either the initial or follow up sessions.

Outline of Self-management support follow up sessions:
1. Brief Introduction (5 mins)
2. Review progress from last visit (5 mins)
3. Partners in Health Scale (5 mins)
4. Cue and Response Interview (10 mins)
5. Discussion to identify any new agreed issues for the care plan (10 mins)
6. Problems and Goals Assessment (15 mins)
7. Update the self-management care plan (5 mins)
8. Wrap up (negotiate date/time for next appointment) and identify next steps (5 mins)

Study fidelity: Training of the intervention providers has been undertaken. Research staff have completed the Flinders training workshop conducted over two days, by the lead research nurse who is an Accredited Flinders Trainer and were assessed as competent against current Flinders competency standards. The training was guided by validated manuals with electronic copies of all training resources and PowerPoint presentation to ensure reproducibility and fidelity of the intervention program.

In addition a self-report evaluation checklist was developed by the research team specifically for the study to guide each interview and to assess fidelity ensuring that all key points are covered during each consultation. The self-report checklist is completed immediately after the consultation by the health professional delivering the intervention and emailed to the research nurse coordinator. Follow up quality assurance checks will also be completed by the research team as part of the study after each consultation. Information around attendance, aspects of the program covered in the first and subsequent sessions, length of consultation visits and records of all face to face consultations and phone contact and the development of a care plan.

The Department of Adolescent Medicine consists of a multidisciplinary team of health professionals, providing quality healthcare to adolescents within a paediatric healthcare setting. The intervention will be delivered by two clinical Nurse Consultants (CNC) who are highly skilled and experienced paediatric nurses who combined have more than 15 years experience in working with the target population. The lead research nurse is an accredited Flinders Trainer and a current PhD candidate. There is also a research Fellow and academic lead who is also an Adolescent Medicine Physician with extensive clinical and research experience. All members of the team are licensed to use the Flinders Program.
Intervention code [1] 319442 0
Treatment: Other
Intervention code [2] 319443 0
Lifestyle
Intervention code [3] 319444 0
Behaviour
Comparator / control treatment
Participants in the waitlist control group will receive standard care for six months before crossing over to the intervention group until all participants are exposed to the intervention. Following baseline data collection and randomisation the waitlist control group will receive standard care which consists of usual patient care practices which are offered by the patient’s individual specialist treating team. In practice this will be general advice on self-management behaviours to a variable degree and frequency. Participants in the control group will be provided with a general information brochure designed specifically for the study after randomisation providing encouragement for participants to think about the concept and goals of self-management. The waitlist control participants will be advised that they will be contacted to start the program in 6 months time.
Control group
Active

Outcomes
Primary outcome [1] 326170 0
Response to treatment as measured by quantitative condition specific validated measurable parameters including laboratory measurement, that can be used to assess the status of a known disease. Response to treatment will be assessed by utilising predetermined measurable parameters, previously developed in conjunction with specialist teams and obtained from the Electronic Medical Records.
Timepoint [1] 326170 0
At baseline, 3 months, 6 months, and 12 months post-commencement of intervention.
Primary outcome [2] 326180 0
Unplanned or unscheduled hospital admissions and emergency department visits due to chronic illness. Data will be obtained from Electronic Medical Records.
Timepoint [2] 326180 0
At baseline, 3 months, 6 months, and 12 months post-commencement of intervention.
Secondary outcome [1] 390356 0
Paediatric Quality of Life Inventory (PedsQL) version 4.0.. This is a widely used instrument that measures health related quality of life (HRQOL) in children and adolescents aged 2-18 years.
Timepoint [1] 390356 0
Baseline, 3 months and 12 months post-commencement of intervention.
Secondary outcome [2] 390395 0
Partners in Health (PIH) Scale . This is a validated, brief, low burden questionnaire which is incorporated in the Flinders Program designed specifically to measure change in self-management behaviours.
Timepoint [2] 390395 0
Baseline, 3 months, 6 months, and 12 months post commencment of intervention.
Secondary outcome [3] 390396 0
An adaptation of the Time Management Questionnaire (TMQ) developed by Britton & Tesser incorporates three sub subscales which will be used in this study to assess short range planning, time attitudes and long range planning.
Timepoint [3] 390396 0
Baseline, 3 months and 12 months post-commencement of intervention. .
Secondary outcome [4] 390397 0
Health related distress - Kessler Psychological Distress Scale (K10).
Timepoint [4] 390397 0
Baseline, 3 months and 12 months post-commencement of intervention.
Secondary outcome [5] 390399 0
Acceptability of the intervention - Semi-structured qualitative questionnaire. This questionnaire was specifically developed by the research team for this study. The Questionnaire consists of 5 questions made up of fixed choice responses and free text options.
Timepoint [5] 390399 0
3 months and 12 months post-commencement of intervention.
Secondary outcome [6] 392516 0
The Partners in Health (PIH) Scale. This scale specifically designed to measure change in health outcomes over time.
Timepoint [6] 392516 0
Baseline, 3 months, 6 months and 12 months post commencement of intervention.
Secondary outcome [7] 392628 0
Feasibility of the intervention - Will be assessed using the semi-structured qualitative questionnaire which was developed specifically for the study and calculated as the number of participants to complete the intervention program including baseline and 3 follow up assessments.
Timepoint [7] 392628 0
3 months and 12 months post-commencement of intervention.

Eligibility
Key inclusion criteria
Aged between 15 - 18 years.
Have a chronic physical condition needing regular health care and requiring the development of self-management skills.
Identified as having unsatisfactory control of this condition by their treatment team.
Not previously participated in a self-management program in the last 2 years.
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adolescents who lack competence in English.
Adolescents with an intellectual disability precluding independent self-management.
Adolescents with any chronic condition with no routinely measurable quantitative condition-specific validated markers of illness control that can be used to identify clinically meaningful endpoints.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potentially eligible participants will be identified by their treating teams, and referred to the research team. Randomisation will be prepared by a statistician with no involvement in the trial prior to the study. Assignment envelopes will be opaque, sealed, sequentially numbered and opened in the correct order when the intervention is assigned. Envelopes will be opened by a clinician who is separate from the recruitment of participants.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by disease condition (diabetes, CF, renal, inflammatory bowel disease, other) and will use permuted blocks to maintain balance.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Waitlist
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Measures of effect will be expressed as relative risk with a decrease of 10% from baseline to 12 months. A study of 54 participants (27 per group) will have 80% power at 5% two-sided alpha to detect a difference in response rates between treatment arms if the rate under usual care is 15% or less and the true difference in proportions is at least 35%, using a chi-square test. To allow for some loss to follow-up, we plan to recruit a total of 60 participants.

Participant demographic and clinical characteristics and study outcomes will be presented using standard descriptive statistics, including mean, standard deviation and range or median, quartiles and range for continuous variables, frequencies and percentages for categorical variables and the Kaplan-Meier method for time to event variables. All statistical analyses will use the intention to treat principle whereby participants are analysed in their randomised groups, regardless of treatment received. The primary outcome of the number of responses in each treatment arm will be compared using a chi-square test and the difference in proportions presented with a 95% confidence interval. Other study outcomes will be compared between randomised groups using standard tests, including chi-square tests for categorical outcomes, two-sample t-tests or nonparametric equivalent for continuous outcomes, Poisson regression models for count data and log-rank test for time-to-event data. For longitudinal outcomes, statistical models that account for the correlation between repeated observations in the same participant will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/04/2021
Actual
17/12/2021
Date of last participant enrolment
Anticipated
30/08/2027
Actual
Date of last data collection
Anticipated
30/08/2027
Actual
Sample size
Target
60
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18469 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 18470 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 32779 0
2145 - Westmead
Recruitment postcode(s) [2] 32780 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307720 0
Hospital
Name [1] 307720 0
Department of Adolescent Medicine, The Children's Hospital at Westmead
Country [1] 307720 0
Australia
Funding source category [2] 308054 0
Hospital
Name [2] 308054 0
The Academic Department of Adolescent Medicine, The Children's Hospital at Westmead
Country [2] 308054 0
Australia
Funding source category [3] 316087 0
Other
Name [3] 316087 0
Estate of Lois Edwin Sharp and Kids Research at The Children's Hospital Network 2022 Mental Health Research Grant
Country [3] 316087 0
Australia
Primary sponsor type
Individual
Name
Mrs Jaunna Gauci
Address
Department of Adolescent Medicine
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 308783 0
None
Name [1] 308783 0
Address [1] 308783 0
Country [1] 308783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307570 0
The Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 307570 0
Ethics committee country [1] 307570 0
Australia
Date submitted for ethics approval [1] 307570 0
09/11/2020
Approval date [1] 307570 0
09/02/2021
Ethics approval number [1] 307570 0

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

Contacts
Principal investigator
Name 107714 0
Mrs Jaunna Gauci
Address 107714 0
Department of Adolescent Medicine
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145
Country 107714 0
Australia
Phone 107714 0
+61 2 9845 2451
Fax 107714 0
+61 2 9845 2517
Email 107714 0
Jane.gauci@health.nsw.gov.au
Contact person for public queries
Name 107715 0
Jaunna Gauci
Address 107715 0
Department of Adolescent Medicine
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145
Country 107715 0
Australia
Phone 107715 0
+61 2 9845 2451
Fax 107715 0
+61 2 9845 2517
Email 107715 0
Jane.gauci@health.nsw.gov.au
Contact person for scientific queries
Name 107716 0
Jaunna Gauci
Address 107716 0
Department of Adolescent Medicine
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145
Country 107716 0
Australia
Phone 107716 0
+61 2 9845 2451
Fax 107716 0
+61 2 9845 2517
Email 107716 0
Jane.gauci@health.nsw.gov.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?
Only non-identifiable individual participant data necessary to substantiate the results reported in any publications by the research team.

When will data be available (start and end dates)?
Data will be made available immediately following publication of the study results up until 15 years post study closure and any soft or hard copies destroyed at this time in accordance with current HREC guidelines.
Available to whom?
Researchers with approval and governance of a Human Ethics Research Ethics Committee, who provide a methodologically sound proposal, case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for individual participant data (IPD) meta-analyses.
How or where can data be obtained?
Access subject to approval by Principal Investigator Mrs Jaunna Gauci (Jane.gauci@health.nsw.gov.au +612 9845 2451)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10292Study protocol  Jane.gauci@health.nsw.gov.au Study protocol has been submitted to a peer review... [More Details]
10293Informed consent form  Jane.gauci@health.nsw.gov.au
10294Ethical approval  Jane.gauci@health.nsw.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial evaluating the effectiveness of a self-management program for adolescents with a chronic condition: a study protocol.2022https://dx.doi.org/10.1186/s13063-022-06740-9
N.B. These documents automatically identified may not have been verified by the study sponsor.