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Trial registered on ANZCTR
Registration number
ACTRN12623001323617
Ethics application status
Approved
Date submitted
22/11/2023
Date registered
18/12/2023
Date last updated
31/05/2024
Date data sharing statement initially provided
18/12/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Hypermobile Online Pain managemEnt (HOPE) for people with hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): a pilot randomised controlled trial of feasibility, acceptability and effectiveness
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Scientific title
Hypermobile Online Pain managemEnt (HOPE) for people with hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobility Spectrum Disorder (HSD): a pilot randomised controlled trial of feasibility, acceptability and effectiveness
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Secondary ID [1]
311013
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
hypermobile Ehlers-Danlos Syndrome (hEDS)
332123
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Hypermobility Spectrum Disorder (HSD)
332124
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Joint Hypermobility Syndrome
332125
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Ehlers-Danlos Syndrome - Hypermobile Type
332126
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Condition category
Condition code
Musculoskeletal
328852
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Online pain management program for hEDS or HSD (HOPE program). The content in this program were developed based on a previous modified Delphi study of participants with the conditions and healthcare professionals who have experience treating the conditions. We are in the process of preparing as a manuscript for submission and it has not been published, we are therefore unable to provide a reference. The HOPE program is an online, 12 modules, 30-45 minutes each module, 2 modules/week program. Participants read through word content including topics like pain neuroscience education, medical and conservative pain management strategies, and lifestyle and behavioural suggestions. There are images and some downloadable pdf files to supplement the word content. Most modules have reflective questions that participants can choose to answer that prompts them reflect on their own pain experiences and to create their own pain action plans. Participants will have access to the program for 8 weeks (2 weeks extra in case they need it, for example due to unexpected health problems). They will be given a login name and password. Participants can access the program at their own time (self-paced) and in their location of choice over 8 weeks. They will also be allowed to continue treatment-as-usual for their pain. After 8 weeks, their access to the program will be discontinued.
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Intervention code [1]
327450
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Rehabilitation
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Intervention code [2]
327451
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Lifestyle
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Intervention code [3]
327452
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Behaviour
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Comparator / control treatment
The treatment-as-usual (control) group will not receive the intervention, instead, they will be encouraged to continue their usual treatments for the pain due to their condition. Usual treatment may consist of treatment such as regular pain medication, regular allied health interventions for pain (such as physiotherapy, massage therapy, clinical psychology), exercise.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Quantitative feasibility outcomes will be measured via website data analytics, research protocol reporting and through online surveys of all participants in the intervention group using the Feasibility of Intervention Measure, FIM. Qualitative feasibility outcomes will be obtained using a 1:1 semi-structured interview of participants in the intervention group. Qualitative outcomes for feasibility will include asking participants questions such as their reasons for adherence or non-adherence to the program and reasons for difficulty engaging with the program.
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Timepoint [1]
336646
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At post-completion of intervention (T1)
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Quantitative acceptability outcomes will be measured via online surveys of all participants in the intervention group using the Acceptability of Intervention Measure. Qualitative acceptability outcomes (such as satisfaction of the usability of the website and content, comprehensibility of the content, intent to continue behaviours for any new skills learnt, suggestions for improvements of the content and website usage) will be obtained using a 1:1 semi-structured interview of participants in the intervention group .
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Timepoint [2]
336647
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At post-completion of intervention (T1)
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Primary outcome [3]
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Appropriateness
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Assessment method [3]
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Quantitative appropriateness outcomes will be measured through online surveys of all participants in the intervention group using the Intervention Appropriateness Measure, IAM. Qualitative appropriateness outcomes (such as usefulness/helpfulness of the program, does the program meet expectations) will be obtained using a 1:1 semi-structured interview of participants in the intervention group
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Timepoint [3]
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At post-completion of intervention (T1)
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Secondary outcome [1]
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Change in use of pain medication and/or other healthcare pain treatment (such as GP, pain specialist, physiotherapy, psychology) over the course of the intervention period
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Assessment method [1]
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Online survey with questions asking "Over the duration of the trial, has your usage of pain medication a) increased, b) decreased, or c) stayed the same)." and "Over the duration of the trial, have you had to see your health professional(s) for your pain: a) more, b) less, or c) same."
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Timepoint [1]
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At post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [2]
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Pain
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Assessment method [2]
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Brief Pain Inventory – Short Form
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Timepoint [2]
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at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [3]
429158
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Impact of joint hypermobility
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Assessment method [3]
429158
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Bristol Impact of Hypermobility
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Timepoint [3]
429158
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at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [4]
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Depression
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Assessment method [4]
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Depression, Anxiety and Stress Scale (DASS-21)
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Timepoint [4]
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at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [5]
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Impression of change
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Assessment method [5]
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Patient Global Impression of Change
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Timepoint [5]
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At post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [6]
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Self-efficacy
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Assessment method [6]
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Patient Self-Efficacy Questionnaire
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Timepoint [6]
429161
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at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [7]
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Adverse event
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Assessment method [7]
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Participants will be asked at T1 to report any adverse events using a Yes/No option and an open-ended question to list and elaborate if their “wellbeing was adversely affected by undertaking the HOPE program”.
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Timepoint [7]
429162
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at post-completion of intervention (T1)
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Secondary outcome [8]
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Participant expectation of change in pain outcome following intervention (Minimal clinically important difference, MCID of the Brief Pain Inventory - Short Form (BPI-SF) score)
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Assessment method [8]
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For pain outcome measured by the BPI-SF, we plan to use a within-person, anchor-based approach to calculate each participant’s MCID. We plan to ask participants the question “How much of an improvement (in percentage) would you expect to consider this intervention (HOPE program, 12 modules, 8 weeks, 1 hour/week, online pain self-management education) as worthwhile?”. We plan to ask this at pre-intervention (T0) and post-intervention (T1). Using the pre-intervention percentage as each participant’s MCID, we can see how many participants reached their MCID post-intervention.
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Timepoint [8]
429163
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at pre-intervention (T0), at post-completion of intervention (T1)
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Secondary outcome [9]
429652
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Anxiety
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Assessment method [9]
429652
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DASS-21
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Timepoint [9]
429652
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at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [10]
429653
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Stress
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Assessment method [10]
429653
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DASS-21
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Timepoint [10]
429653
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at pre-intervention (T0), at post-completion of intervention (T1) and at 3-months post-completion of intervention (T2)
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Secondary outcome [11]
430028
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Participant expectation of change in impact of hypermobility outcome following intervention (Minimal clinically important difference, MCID of the Bristol Impact of Hypermobility (BIoH))
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Assessment method [11]
430028
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For impact of hypermobility outcome measured by the Bristol Impact of Hypermobility, we plan to use a within-person, anchor-based approach to calculate each participant’s MCID. We plan to ask participants the question “How much of an improvement (in percentage) would you expect to consider this intervention (HOPE program, 12 modules, 8 weeks, 1 hour/week, online pain self-management education) as worthwhile?”. We plan to ask this at pre-intervention (T0) and post-intervention (T1). Using the pre-intervention percentage as each participant’s MCID, we can see how many participants reached their MCID post-intervention.
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Timepoint [11]
430028
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at pre-intervention (T0), at post-completion of intervention (T1)
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Secondary outcome [12]
430029
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Participant expectation of change in depression outcome following intervention (Minimal clinically important difference, MCID of the Depression, Anxiety and Stress Scale (DASS-21))
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Assessment method [12]
430029
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For depression outcome measured by the DASS-21, we plan to use a within-person, anchor-based approach to calculate each participant’s MCID. We plan to ask participants the question “How much of an improvement (in percentage) would you expect to consider this intervention (HOPE program, 12 modules, 8 weeks, 1 hour/week, online pain self-management education) as worthwhile?”. We plan to ask this at pre-intervention (T0) and post-intervention (T1). Using the pre-intervention percentage as each participant’s MCID, we can see how many participants reached their MCID post-intervention.
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Timepoint [12]
430029
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at pre-intervention (T0), at post-completion of intervention (T1)
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Secondary outcome [13]
430030
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Participant expectation of change in anxiety outcome following intervention (Minimal clinically important difference, MCID of the Depression, Anxiety and Stress Scale (DASS-21))
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Assessment method [13]
430030
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For anxiety outcome measured by the DASS-21, we plan to use a within-person, anchor-based approach to calculate each participant’s MCID. We plan to ask participants the question “How much of an improvement (in percentage) would you expect to consider this intervention (HOPE program, 12 modules, 8 weeks, 1 hour/week, online pain self-management education) as worthwhile?”. We plan to ask this at pre-intervention (T0) and post-intervention (T1). Using the pre-intervention percentage as each participant’s MCID, we can see how many participants reached their MCID post-intervention.
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Timepoint [13]
430030
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at pre-intervention (T0), at post-completion of intervention (T1)
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Secondary outcome [14]
430031
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Participant expectation of change in stress outcome following intervention (Minimal clinically important difference, MCID of the Depression, Anxiety and Stress Scale (DASS-21))
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Assessment method [14]
430031
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For stress outcome measured by the DASS-21, we plan to use a within-person, anchor-based approach to calculate each participant’s MCID. We plan to ask participants the question “How much of an improvement (in percentage) would you expect to consider this intervention (HOPE program, 12 modules, 8 weeks, 1 hour/week, online pain self-management education) as worthwhile?”. We plan to ask this at pre-intervention (T0) and post-intervention (T1). Using the pre-intervention percentage as each participant’s MCID, we can see how many participants reached their MCID post-intervention.
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Timepoint [14]
430031
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at pre-intervention (T0), at post-completion of intervention (T1)
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Secondary outcome [15]
430032
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Participant expectation of change in global impression of change following intervention (Minimal clinically important difference, MCID of the Patient Global Impression of Change (PGIC))
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Assessment method [15]
430032
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For global impression of change outcome measured by the PGIC, we plan to use a within-person, anchor-based approach to calculate each participant’s MCID. We plan to ask participants the question “How much of an improvement (in percentage) would you expect to consider this intervention (HOPE program, 12 modules, 8 weeks, 1 hour/week, online pain self-management education) as worthwhile?”. We plan to ask this at pre-intervention (T0) and post-intervention (T1). Using the pre-intervention percentage as each participant’s MCID, we can see how many participants reached their MCID post-intervention.
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Timepoint [15]
430032
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at pre-intervention (T0), at post-completion of intervention (T1)
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Secondary outcome [16]
430033
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Participant expectation of change in pain self-efficacy following intervention (Minimal clinically important difference, MCID of the Patient Self-Efficacy Questionnaire (PSEQ))
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Assessment method [16]
430033
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For pain self-efficacy outcome measured by the PSEQ, we plan to use a within-person, anchor-based approach to calculate each participant’s MCID. We plan to ask participants the question “How much of an improvement (in percentage) would you expect to consider this intervention (HOPE program, 12 modules, 8 weeks, 1 hour/week, online pain self-management education) as worthwhile?”. We plan to ask this at pre-intervention (T0) and post-intervention (T1). Using the pre-intervention percentage as each participant’s MCID, we can see how many participants reached their MCID post-intervention.
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Timepoint [16]
430033
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at pre-intervention (T0), at post-completion of intervention (T1)
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Eligibility
Key inclusion criteria
• Adults aged 18 and over
• Australian residents
• Diagnosed with hEDS or HSD or Joint Hypermobility Syndrome (JHS) or Ehlers-Danlos Syndrome – Hypermobility Type (EDS-HT) by a medical doctor (e.g. rheumatologist, geneticist, general practitioner)
• Presence of pain for more than 3 months
• Sufficient English proficiency to engage with program and interview
• Have access to a desktop/laptop and internet over the course of the program
• Stable dosage and type of pain medication in the last 3 months
• Stable medical or allied health interventions for pain (such as Physiotherapy, Psychology) in the last 3 months
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Severe depression (Patient Health Questionnaire (PHQ-9) score >=20)
• Significant suicidal ideation (PHQ-9 score >2 on item 9)
• Co-existing medical conditions causing pain not known to be associated with hEDS/HSD such as active cancer, active inflammatory joint conditions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. We were able to perform allocation concealment by having member A (not involved in the recruitment) create the allocation sequence via an online sequence generator, and another member B (involved in the recruitment but blinded to the allocation sequence) would ask member A for an allocation each time a participant was enrolled.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into either control group or intervention group using a permuted block randomisation, using a computer-generated random sequence generator
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/01/2024
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Actual
30/01/2024
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Date of last participant enrolment
Anticipated
30/04/2024
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Actual
13/03/2024
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Date of last data collection
Anticipated
4/10/2024
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Actual
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Sample size
Target
70
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Accrual to date
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Final
73
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Macquarie University
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Address [1]
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Ground floor, 75 Talavera Road, Macquarie University, NSW 2109, Australia
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
Ground floor, 75 Talavera Road, Macquarie University, NSW 2109, Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
317313
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Address [1]
317313
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Country [1]
317313
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Macquarie University HREC Medical Sciences Committee
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Ethics committee address [1]
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Research Services, Ground Floor, 16 Wally's Walk Macquarie University, NSW 2109, Australia
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/10/2023
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Approval date [1]
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21/11/2023
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Ethics approval number [1]
314195
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520231630154261
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Summary
Brief summary
The HOPE program is an new online pain management program for people with hypermobile Ehlers-Danlos Syndrome or Hypermobility Spectrum Disorder. This aim of this study is to assess its feasibility, acceptability and effectiveness. We will be comparing the intervention group to a treatment-as-usual group. Outcomes will include online surveys asking about the program's feasibility and acceptability, and interviews with participants in the HOPE program on their experience with it.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Cliffton Chan
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Address
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Ground Floor, 75 Talavera Rd, Macquarie University, NSW 2109, Australia
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Country
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Australia
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Phone
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+61 2 98506618
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Cliffton Chan
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Address
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Ground Floor, 75 Talavera Rd, Macquarie University, NSW 2109, Australia
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Country
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Australia
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Phone
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+61 2 98506618
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Fax
130751
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Email
130751
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[email protected]
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Contact person for scientific queries
Name
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Cliffton Chan
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Address
130752
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Ground Floor, 75 Talavera Rd, Macquarie University, NSW 2109, Australia
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Country
130752
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Australia
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Phone
130752
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+61 2 98506618
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Fax
130752
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Email
130752
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified outcome measures
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When will data be available (start and end dates)?
Data will be made available in the Macquarie University data repository within 18 months after publication in a peer-reviewed journal, with no end date
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Available to whom?
Data is open and will be licensed CC-BY International 4.0, requiring citation.
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Available for what types of analyses?
Any analyses but subject to consultation with Principal Investigator
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How or where can data be obtained?
Macquarie Research Data Repository and correspondence with Principal Investigator Cliffton Chan (email address:
[email protected]
, phone +61 2 9850 6618)
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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.
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