Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001107910
Ethics application status
Approved
Date submitted
15/07/2020
Date registered
26/10/2020
Date last updated
26/10/2020
Date data sharing statement initially provided
26/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Family Based Treatment via Telemedicine for Regional and Rural Young People with Anorexia Nervosa
Scientific title
Family Based Treatment via Telemedicine for Regional and Rural Young People with Anorexia Nervosa
Secondary ID [1] 301785 0
nil
Universal Trial Number (UTN)
Trial acronym
FBT-TRRAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anorexia nervosa 318261 0
Condition category
Condition code
Mental Health 316270 316270 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
18 sessions of Family Based Treatment (FBT) will be delivered to young people diagnosed with Anorexia Nervosa (AN) and their families.
Materials used: Online survey (via REDCap), Videoconferencing platform, digital scales.
Procedures: After consent and before meeting with the therapist, a member of the research team will contact the family to perform a technology check, to troubleshoot any technology issues (i.e., video camera not working, teleconferencing platform issues or connection/speed issues), and offer education and training support concerning the videoconferencing platform. Before commencing therapy, the family will have a brief session with the therapist (online or face to face within the service). The purpose of this session is to orientate the family to the treatment format, describe the treatment process and discuss logistics that will enhance the therapy experience.
Before each scheduled session, the young person will be weighed using the same scales and in the same location of the house by the parent/guardian. As soon as the parents/guardians have measured the young person’s weight, they will send the weight to the therapist via email or text. As per the FBT manual, the young person will be weighed wearing light indoor clothing, no shoes and after voiding their bladder. The parents/guardians will be instructed by the therapist how to do this during the first session. The therapist will initiate the therapy session, and begin with an individual meeting with the young person. Following a review of the weekly weight and check in with the young person, the remaining family members will join the young person and therapist.
FBT comprises of three treatment phases. In phase 1, the parents are charged with the responsibility of managing eating behaviours and weight gain. In phase 2, parents gradually transition the responsibility of eating back to the adolescent in an age-appropriate manner. In phase 3, adolescent developmental issues (such as peer friendships or managing school/studies) become the focus of treatment. Due to the seriousness of AN, FBT requires all family members to attend sessions, and that appointments are at least weekly for the first several months. This frequency of appointments generally reduces as the young person becomes progressively well.
Who will deliver: Experience mental health professionals employed by NSW Health trained in FBT
Mode: Online via telemedicine (i.e., Pexip or Skype for Business)
Number of times delivered: 18 sessions over 9 months. Sessions will initially be on a weekly basis for the first three months, and then fortnightly and then monthly, as determined by consultation between the clinician and their families.
Location/setting: Online. The family will be in their home and therapist will be in their mental health service.
Fidelity: Treatment fidelity will be managed by therapists completing two workshops and weekly supervision with Investigator and co-author of the FBT treatment manual. Furthermore, therapists will complete a brief checklist after each session and will use these to guide supervision discussions.
Intervention code [1] 318086 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324448 0
The primary outcome will be change in weight from baseline to end-of-treatment and baseline to six-months-follow-up. Weight will be measured using digital scales, in the same location of the house before each session. It will then be converted into %median body mass index (BMI).
Timepoint [1] 324448 0
End of Treatment and Six Months Follow Up
Primary outcome [2] 324697 0
Change in Global Eating Disorder Symptomology (as measured by the EDE/PEDE interview and/or EDE-Q/PEDE-Q).
Timepoint [2] 324697 0
End of treatment and Six Month Follow-Up
Secondary outcome [1] 384700 0
Acceptability and Feasibility
Treatment acceptability and feasibility will be determined by the quantitative and qualitative data obtained from online surveys and semi-structured interviews with the young person, family members and therapist. The online survey and interviews were designed specifically for this study, and cover topics such as: what helped, did not help, impact on the symptoms, satisfaction,
To examine the feasibility and acceptability of using telemedicine to deliver FBT we will utilise a mixed-method approach to analyse: (a) the number of patients/families that expressed interest in participating in the study; (b) the number of patients/families enrolled in the study (i.e., an indicator of treatment feasibility); (c) the number and percent of patients/families that completed at least 10 sessions (i.e., an indicator of treatment engagement); (d) the number of patients/families completing the full course of treatment (18 sessions; i.e., an indicator of treatment retention); (e) the results from the post-treatment evaluation survey and semi-structured interview by family members (i.e., family acceptability); (f) the results from the post-treatment evaluation survey and semi-structured interview by young people (i.e., young person acceptability); and (g) the results from the post-treatment evaluation survey and semi-structured interview by therapists (i.e., therapist acceptability).
A qualitative analysis will examine the participants’ responses to the semi-structured interviews that take place at end of treatment. Given the lack of theory or framework regarding family acceptability and feasibility using telemedicine, a conventional content analysis method will be used. The interviews will be analysed within and between participant roles (i.e., young persons, parents/guardians, siblings/other members and therapists) to determine what themes emerge that are similar across the groups, as well as those unique to each group. Two investigators with experience in qualitative research will immerse themselves in the data and allow for categories and names for categories to emerge from the data.
Timepoint [1] 384700 0
End of Treatment and Six Months Follow Up
Secondary outcome [2] 385425 0
Cost effectiveness will be determined by collecting costs to participants through study-specific cost questionnaires and health outcomes (i.e., quality of life data using the EQ-5D), costs of treatment (face to face compared with telehealth) etc.


Timepoint [2] 385425 0
Cost effectivness data will be collected at baseline, mid-treatment, end of treatment and six-months follow up.

Eligibility
Key inclusion criteria
In relation to the young person diagnosed with AN:
• Diagnosis of AN as defined by the DSM-5
• Age: 12 to 18 years old
• Living with primary caregiver
• Medically stable for outpatient treatment according to the recommended thresholds of the NSW Health Guidelines for the Admission of Children and Young People with an Eating Disorder (2014), as verified by their treating general practitioner (GP)
• Commitment from the family to engage in FBT
• Not engaged in any other psychological or dietetic treatment external to mental health service

In relation to the other family members (parents/guardians, siblings)
* Aged over 12 years of age
* Not currently under a mental health act
* Commitment to engage in Family Based Treatment
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In relation to the young person diagnosed with AN:
• Currently pregnant
• Current manic episode or psychosis
• Current alcohol, substance abuse or dependence
• Acute suicidality
• Significant medical or neurological disorders not relating to their primary diagnosis of AN
• GP unable to provide medical clearance
• Under the Mental Health Act or under compulsory treatment orders

Study design
Purpose of the study
Treatment
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
Aims
1) The effectiveness of FBT delivered via telemedicine in reducing core eating disorder symptomology, as well as general mood and anxiety, and improving quality of life to young persons with AN and their families living in regional and rural NSW, Australia
2) The feasibility and acceptability of using telemedicine into the home to deliver FBT to young persons with AN and their families; and
3) Economic costs and health consequences (clinical and quality of life outcomes) of using telemedicine to deliver FBT directly into the home, as opposed to standard care (i.e. face-to-face treatment).

To address Aim 1, a mixed model regression will be used to determine the effectiveness of the treatment using %mBMI as the primary outcome. In addition, mixed model regression will be used to compare change for all the other clinical outcomes mentioned above. Frequency data relating to enrolment and completion will be analysed using descriptive statistics. To address Aim 2, the results from the post-treatment evaluation and semi-structured interview will be analysed using mixed methods.
To address Aim 3, the health economics analysis will consist of a cost-consequence analysis of the treatment intervention using before and after costs and outcomes data. Additionally, the impact of socioeconomic, demographic, and health-related factors for changes in quality of life outcomes (and acceptability) of participants and their family members/guardians over time will be assessed using panel data methods. Changes in inequalities in access to health care sought through the collection of personal (demographic) data as well as data on health care need based on severity and length of illness, how services have been sought, reach, the use of health care services, and the degree to which need for services has been met by this telemedicine intervention will also be assessed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/07/2020
Date of last participant enrolment
Anticipated
13/01/2022
Actual
Date of last data collection
Anticipated
17/09/2022
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306218 0
Charities/Societies/Foundations
Name [1] 306218 0
Charles Warman Foundation
Country [1] 306218 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
PO Box M30
Missenden Road, NSW, 2050
Country
Australia
Secondary sponsor category [1] 306695 0
None
Name [1] 306695 0
Address [1] 306695 0
Country [1] 306695 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306430 0
Sydney Local health District Royal Prince Alfred Hospital
Ethics committee address [1] 306430 0
Ethics committee country [1] 306430 0
Australia
Date submitted for ethics approval [1] 306430 0
28/01/2020
Approval date [1] 306430 0
21/04/2020
Ethics approval number [1] 306430 0

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

Contacts
Principal investigator
Name 103842 0
Dr Sarah Maguire
Address 103842 0
InsideOut Institute
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Charles Perkins Centre D17 | The University of Sydney | NSW | 2006
Country 103842 0
Australia
Phone 103842 0
+610286275690
Fax 103842 0
Email 103842 0
[email protected]
Contact person for public queries
Name 103843 0
Ashlea Hambleton
Address 103843 0
InsideOut Institute
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Charles Perkins Centre D17 | The University of Sydney | NSW | 2006
Country 103843 0
Australia
Phone 103843 0
+610286275690
Fax 103843 0
Email 103843 0
[email protected]
Contact person for scientific queries
Name 103844 0
Ashlea Hambleton
Address 103844 0
InsideOut Institute
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders
Charles Perkins Centre D17 | The University of Sydney | NSW | 2006
Country 103844 0
Australia
Phone 103844 0
+610286275690
Fax 103844 0
Email 103844 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


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.