ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Chronic illness

Medication adherence

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Respiratory

Other respiratory disorders / diseases

Inflammatory and Immune System

Other inflammatory or immune system disorders

Neurological

Epilepsy

Oral and Gastrointestinal

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

At baseline, 3 months, 6 months, and 12 months post-commencement of intervention.

Primary outcome [2]

Unplanned or unscheduled hospital admissions and emergency department visits due to chronic illness. Data will be obtained from Electronic Medical Records.

Timepoint [2]

At baseline, 3 months, 6 months, and 12 months post-commencement of intervention.

Secondary outcome [1]

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]

Baseline, 3 months and 12 months post-commencement of intervention.

Secondary outcome [2]

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]

Baseline, 3 months, 6 months, and 12 months post commencment of intervention.

Secondary outcome [3]

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]

Baseline, 3 months and 12 months post-commencement of intervention. .

Secondary outcome [4]

Health related distress - Kessler Psychological Distress Scale (K10).

Timepoint [4]

Baseline, 3 months and 12 months post-commencement of intervention.

Secondary outcome [5]

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]

3 months and 12 months post-commencement of intervention.

Secondary outcome [6]

The Partners in Health (PIH) Scale. This scale specifically designed to measure change in health outcomes over time.

Timepoint [6]

Baseline, 3 months, 6 months and 12 months post commencement of intervention.

Secondary outcome [7]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [2]

Sydney Children's Hospital - Randwick

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Adolescent Medicine, The Children's Hospital at Westmead

Address [1]

Locked Bag 4001
Westmead NSW 2145

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

The Academic Department of Adolescent Medicine, The Children's Hospital at Westmead

Address [2]

Locked Bag 4001
Westmead NSW 2145

Country [2]

Australia

Funding source category [3]

Other

Name [3]

Estate of Lois Edwin Sharp and Kids Research at The Children's Hospital Network 2022 Mental Health Research Grant

Address [3]

The Sydney Children's Hospital Network

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Sydney Children's Hospitals Network Human Research Ethics Committee

Ethics committee address [1]

The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/11/2020

Approval date [1]

09/02/2021

Ethics approval number [1]

Summary

Brief summary

This study has been designed to provide evidence of the effectiveness of self-management programs for adolescents with chronic medical conditions aged 15-18 years prior to their transfer to adult care. It is the first study to use the validated and internationally recognised Flinders Chronic Condition Management Program (Flinders Program™) with this important but under researched age group.

The study hypothesis is that a modified adult, generic chronic condition self-management program provided to adolescents with a chronic condition would be more effective than standard usual care in achieving adherence to chronic condition management as measured by quantitative condition specific validated markers of illness control, global quality of life, self-efficacy, time management, and in reducing health related distress.

This study will provide a better understanding of the components required for effective self-management programs in adolescents with a chronic condition. Participants will be randomised to either standard care or the modified Flinders Program™ plus standard care. Data collection will include measures of specific chronic condition control, unscheduled hospital admissions and questionnaires to record self-management competencies, quality of life, self-efficacy and outcomes measures specific to the program at baseline, 3 months, 6 and 12 months after delivery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Jaunna Gauci

Address

Department of Adolescent Medicine
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 2451

Fax

+61 2 9845 2517

[email protected]

Contact person for public queries

Name

Mrs Jaunna Gauci

Address

Department of Adolescent Medicine
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 2451

Fax

+61 2 9845 2517

[email protected]

Contact person for scientific queries

Name

Mrs Jaunna Gauci

Address

Department of Adolescent Medicine
The Children's Hospital at Westmead
Locked Bag 4001,
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 2451

Fax

+61 2 9845 2517

[email protected]

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 ([email protected] +612 9845 2451)

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
10292	Study protocol	[email protected]	Study protocol has been submitted to a peer review... [More Details]
10293	Informed consent form	[email protected]
10294	Ethical approval	[email protected]

Results publications and other study-related documents

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A randomized controlled trial evaluating the effectiveness of a self-management program for adolescents with a chronic condition: a study protocol.	2022	https://dx.doi.org/10.1186/s13063-022-06740-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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