Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000598684
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
1/06/2023
Date last updated
5/11/2024
Date data sharing statement initially provided
1/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-Designing, Implementing, and Evaluating Supportive Care for Endometriosis (CodeEndo)
Scientific title
Co-designing and implementing 'CodeEndo': an online modular supportive care program and evaluating its impact on quality of life (and other biopsychosocial outcomes) for people living with endometriosis.
Secondary ID [1] 309550 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CodeEndo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 329839 0
Condition category
Condition code
Reproductive Health and Childbirth 326750 326750 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CodeEndo is a online modular self-directed supportive care program for people living with endometriosis.

Phase 1: This phase will occur first, involving refining the structure and content of the CoDeEndo program, utilizing interviews and focus groups with consumers (i.e. those living with endometriosis) and collaboration with stakeholders (i.e. consumer representatives and endometriosis-related healthcare providers). The frequency and duration of interviews, focus groups, and collaboration will occur on a needs basis throughout this phase and may include for example review of intervention materials, meetings, and online platform feedback. In this phase the final intervention will be created and embedded into an online platform, with the total duration of this phase being 1.5 years.

Phase 2: This phase will follow phase 1, by evaluating the efficacy of the CoDeEndo program. The program will run for 8-weeks and includes 9 interventions each containing a number of sub-modules. The 9 interventions include - Mindfulness, Psychoeducation, Relaxation, Physiotherapy, Acceptance and Commitment Therapy, Hypnotherapy, Yoga, Cognitive Behavioral Therapy, and Dietary Education. Modules are comprised of a mix of video, audio, podcasts, and written resources. Participants will have access to all modules throughout the 8-weeks, allowing for observation of natural use. Participants will also be encouraged to practice (repeat) the modules throughout the 8-weeks. This means that participants can choose to spend as little as 5-mins to several hours per week accessing the CodeEndo Program. Participants will also receive weekly email reminders directing them to CoDeEndo. The specific goals of the intervention will vary for each person, depending on their individual symptoms, severity of disease, expectations and motivations, life experience, and what they want to achieve from the intervention. There are two strategies to monitor adherence to the intervention. 1) The website used to deliver the intervention has an inbuilt tracking system, which is able to provide detailed data regarding participant intervention usage. 2) Also embedded into the website are questions are the end of each module/week asking participants to self-report their usage of the intervention.
Intervention code [1] 325976 0
Behaviour
Intervention code [2] 325977 0
Lifestyle
Intervention code [3] 326054 0
Treatment: Other
Comparator / control treatment
Waitlist Control: Participants randomised to the waitlist control group will continue their treatment-as-usual and be offered access to the CodeEndo program at the end of providing their final follow-up questionnaire (6-months post-randomisation).
Control group
Active

Outcomes
Primary outcome [1] 334604 0
Endometriosis-related quality of life measured by the 30-item endometriosis Health Profile (EHP-30)
Timepoint [1] 334604 0
Baseline, post-treatment at 8 weeks and 6 months (primary endpoint) since baseline
Primary outcome [2] 334605 0
Quality of life will be measured by the Euroqol (EQ)-5D-5L
Timepoint [2] 334605 0
Baseline, post-treatment at 8 weeks and 6 months (primary endpoint) since baseline
Secondary outcome [1] 421378 0
Self-efficacy with the Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [1] 421378 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [2] 421379 0
Psychological symptoms with the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [2] 421379 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [3] 421380 0
Fatigue with the Fatigue Symptom Inventory (FSI)
Timepoint [3] 421380 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [4] 421381 0
Menstrual symptoms with the Menstrual Symptoms Questionnaire (MSQ)
Timepoint [4] 421381 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [5] 421382 0
Health utilization and cost data via a consumer health economics questionnaires and participants Services Australia usage - this questionnaire has been designed specifically for this study.
Timepoint [5] 421382 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [6] 421383 0
Gastrointestinal symptom data will be collected using the Gastrointestinal Symptom Rating Scale
Timepoint [6] 421383 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [7] 421384 0
Diet data on a 3-day food diary (composite: energy, nutrient and FODMAP intake on Foodworks and the Monash FODMAP calculator)
Timepoint [7] 421384 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [8] 441440 0
Exercise via the Brief Physical Activity Scale
Timepoint [8] 441440 0
Secondary outcome [9] 441441 0
Exercise via the Brief Physical Activity Scale
Timepoint [9] 441441 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [10] 441442 0
Bladder symptoms via the Interstitial Cystitis Symptom and Problem Questionnaire.
Timepoint [10] 441442 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [11] 441443 0
Bladder symptoms via the Interstitial Cystitis Symptom and Problem Questionnaire.
Timepoint [11] 441443 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [12] 441444 0
Sleep via the Jenkins Sleep Questionnaire
Timepoint [12] 441444 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [13] 441445 0
Sleep via the Jenkins Sleep Questionnaire
Timepoint [13] 441445 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [14] 441446 0
Physical well-being via Numerical Rating Scale
Timepoint [14] 441446 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [15] 441447 0
Physical well-being via Numerical Rating Scale
Timepoint [15] 441447 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [16] 441448 0
Pain via numerical rating scales.
Timepoint [16] 441448 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [17] 441449 0
Pain via numerical rating scales.
Timepoint [17] 441449 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [18] 441450 0
Most Bothersome Symptom via Numerical Rating Scale
Timepoint [18] 441450 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [19] 441451 0
Most Bothersome Symptom via Numerical Rating Scale
Timepoint [19] 441451 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [20] 441452 0
Treatment changes via open-ended self-report question.
Timepoint [20] 441452 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [21] 441453 0
Treatment changes via open-ended self-report question.
Timepoint [21] 441453 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [22] 441454 0
Mental well-being via Numerical Rating Scale
Timepoint [22] 441454 0
Baseline, post-treatment at 8 weeks and 6 months since baseline
Secondary outcome [23] 441455 0
Mental well-being via Numerical Rating Scale
Timepoint [23] 441455 0
Baseline, post-treatment at 8 weeks and 6 months since baseline

Eligibility
Key inclusion criteria
Trial Participants:
Inclusion criteria:
- Can provide proof of endometriosis diagnosis. (This can include a letter from a doctor, results of histology, operation reports, ultrasound scan, or any other medical document confirming their diagnosis).
- Be Aged 18+.
- Live in Australia.
- Not pregnant.
- Proficient in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Trial Participants
Exclusion criteria:
- Recent endometriosis-related surgery within the last 6-months.
- No psychological distress (Screened via K10 - score of 15 or below).
- Extreme dissociative experiences (screened via Brief Dissociative Experiences Scale (DES-B) - score of 2.5 or above).
- Cognitive impairment (Screened via psychologist interview)
- Suicide/Self-harm (Screened via psychologist interview)
- Substance Use/Dependence (Screened via psychologist interview)
- Bipolar I or Bipolar II (Screened via psychologist interview)
- Schizophrenia/Psychosis (Screened via psychologist interview)
- Post Traumatic Stress Disorder (Screened via psychologist interview)
- Borderline Personality Disorder (Screened via psychologist interview)

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)
An automated block randomisation sequence with variable block size will be embedded into Qualtrics for allocation concealment. The study biostatistician will not be involved in participant recruitment and will be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomly assigned (1:1 ratio) to CodeEndo or Wait-List Control following completion of baseline questionnaire. A block randomisation sequence with variable block size will be embedded into Qualtrics for allocation concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses is planned to be conducted on an intention-to-treat basis. The intervention effect over time (baseline T1, 8-weeks T2, and 6-months T3) on the primary outcomes (EHP-30 and EQ-5D-5L) and the secondary outcomes (all other biopsychosocial outcomes) will be estimated using linear mixed models. The models will include group (intervention, control), time (T1, T2, T3), and group x time interaction effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2025
Actual
Date of last participant enrolment
Anticipated
1/11/2026
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
352
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313742 0
Government body
Name [1] 313742 0
National Health and Medical Research Council
Country [1] 313742 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
Geelong Waurn Ponds Campus
Locked Bag 20000
Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 315558 0
None
Name [1] 315558 0
Address [1] 315558 0
Country [1] 315558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312914 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 312914 0
Human Research Ethics Office Deakin University 221 Burwood Hwy Burwood, VIC 3125
Ethics committee country [1] 312914 0
Australia
Date submitted for ethics approval [1] 312914 0
19/06/2023
Approval date [1] 312914 0
19/06/2024
Ethics approval number [1] 312914 0

Summary
Brief summary
Endometriosis is a chronic condition in which tissue similar to that lining the uterus grows on other organs, leading to scarring and adhesions and causing pain, menstrual irregularities, and infertility. Impacting 11% of Australian women and those assigned female at birth, endometriosis is under-recognised due to the variability in symptoms, reliance on surgery for diagnosis, and stigma of menstruation. Usual care, comprising of hormone and pain medications, has limited efficacy, is associated with adverse effects, and is discontinued by up to 40% of people. Recognising the inadequacy of the current biomedical healthcare approach to treating endometriosis, there is a need to address the complex psychosocial burden of endometriosis, and there are calls for urgent improvements in access to consumer-centred pain management. The current study will refine the structure and content of 'CodeEndo' – an online modular supportive care program for people living with endometriosis. The project will then evaluate the efficacy of the CodeEndo program using a randomised controlled trial, comparing it to waitlist control on quality of life and other important endometriosis-related biopsychosocial outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126314 0
Prof Antonina Mikocka-Walus
Address 126314 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 126314 0
Australia
Phone 126314 0
+61392468575
Fax 126314 0
Email 126314 0
[email protected]
Contact person for public queries
Name 126315 0
Colette Naude
Address 126315 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 126315 0
Australia
Phone 126315 0
+61392468575
Fax 126315 0
Email 126315 0
[email protected]
Contact person for scientific queries
Name 126316 0
Antonina Mikocka-Walus
Address 126316 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 126316 0
Australia
Phone 126316 0
+61392468575
Fax 126316 0
Email 126316 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
We believe participants (a chronically ill cohort) may be reluctant to participate if we decided to share their health-related data. Further, we are initiating a program of research in this area and want our team to be able to use the data in future publications. This is not a large dataset and thus by opening it to others we might lose the opportunity to publish the data ourselves.


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.