Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000663651p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2023
Date registered
20/06/2023
Date last updated
20/06/2023
Date data sharing statement initially provided
20/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Long COVID-19 Student-delivered program - a randomised controlled trial comparing the effectiveness of multiple sessions of chronic disease management to a single session of the same program.
Scientific title
A Long COVID-19 Student-delivered program - a randomised controlled trial comparing the effectiveness of multiple sessions of chronic disease management to a single session of the same program.
Secondary ID [1] 309744 0
Nil known
Universal Trial Number (UTN)
U1111-1293-0453
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 330139 0
Condition category
Condition code
Inflammatory and Immune System 327020 327020 0 0
Other inflammatory or immune system disorders
Infection 327095 327095 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chronic disease management, tailored to the participant's symptoms and goals, will be delivered in the form of health coaching.
The intervention will be delivered by pre-registration health professional students (dietetics, occupational therapy, paramedicine, physiotherapy, social work) under the supervision of health professionals from their own profession with at least 3 years experience.
We will use a two-group, randomised controlled trial design with primary outcome measurement at 3 months. The intervention group - Group 2 will have up to 12 sessions of the intervention before the outcomes measured at 3 months; followed by a second measure of outcomes at 6 months.
The chronic disease self management sessions will consist of the identification and prioritisation of participant problems; shared goal setting and then shared decision making about actions to reach these goals. Scripts have been developed in surveys to guide the conversations between the students and the participants.
Sessions will be delivered one-on-one by telephone, video conference or face to face and will last for up to an hour each. They will be scheduled at times suited to the participant and may be up to weekly. Students will record notes during each attendance about conversations and progress towards goals.
Participants will be given an information booklet designed by the Royal Australian College of General Practitioners https://www.racgp.org.au/clinical-resources/covid-19-resources/patient-resources/patient-resource-managing-post-covid-19-symptoms/introduction
Exercise advise will be given using the Borg pacing protocol outlined in https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.28373
Before the students engage with any participants, they must have completed 10 hours of online telehealth training and 3 hours of training specifically designed to inform them about Long COVID aetiology and symptoms, impact on daily life, symptom management and this research trial, including the screening tool and outcome measures. The online training platform allows supervisors to check that students have completed the training. They also need to record mock participant interactions and these are graded as pass or fail by a supervisor. Students cannot begin interacting with participants until they have completed the training and passed the assessments.
Intervention code [1] 326183 0
Rehabilitation
Intervention code [2] 326184 0
Behaviour
Intervention code [3] 326185 0
Lifestyle
Comparator / control treatment
Group 1 (comparator) will receive a single session prior to outcomes measures at 3 months.
This session will consist of a discussion about priority of symptoms and what they have tried previously. Participants will be given an information booklet designed by the Royal Australian College of General Practitioners https://www.racgp.org.au/clinical-resources/covid-19-resources/patient-resources/patient-resource-managing-post-covid-19-symptoms/introduction
Control group
Dose comparison

Outcomes
Primary outcome [1] 334883 0
Change in a 7 point Global Impression of Change score (Guy 1976)
Timepoint [1] 334883 0
3 months & 6 months post-commencement of the intervention
Secondary outcome [1] 422335 0
Changes in the within item 'now' scores of the the modified COVID-19 Yorkshire Rehabilitation Scale (C19YRS) (Silvan 2022). The C19YRS is a patient reported outcome measure.
Outcomes measured will be: breathlessness, cough, fatigue, pain, cognition, palpitations, dizziness, post exertional malaise, anxiety, depression, communication, mobility, personal care, social role & vocation


For example, participant reported score on Fatigue at commencement compared to 3 and 6 months post commencement.
Timepoint [1] 422335 0
At commencement, at 3 months & at 6 months post-commencement of the intervention
Secondary outcome [2] 422336 0
Changes in the index value in the Five Dimension, Five Level EuroQol (EQ-5D-5L) (Feng 2021). (Norman, 2023)
the index value is made up if score for mobility, self care, usual activities, pain/discomfort, anxiety/depression
Timepoint [2] 422336 0
At commencement, at 3 months & at 6 months post-commencement of the intervention
Secondary outcome [3] 422337 0
Changes in participants' usage of health professionals and the associated costs will be measured using a study specific questionnaire. Participants will be asked how many times they attended a general practitioner appointment in the previous 3 months; how often they attended other health professionals in the previous 3 months; and what profession these people were. Costs will be calculated using market-based valuation (Drummond, 2001).
Timepoint [3] 422337 0
At commencement, at 3 months & at 6 months post-commencement of the intervention
Secondary outcome [4] 422338 0
Therapeutic alliance will be determined using the Working Alliance Inventory questionnaire (Horvath, 1989)'. This will be completed the participants
Timepoint [4] 422338 0
3 and 6 months post-commencement of the intervention
Secondary outcome [5] 422694 0
Therapeutic alliance will be determined using the Working Alliance Inventory questionnaire (Horvath, 1989)'. This will be completed the students
Timepoint [5] 422694 0
3 and 6 months post-commencement of the intervention
Secondary outcome [6] 422697 0
Participation profile of people engaged in Group 2. This will be measured using a study specific questionnaires and by auditing study records. Information collected will include participant demographics, number of sessions completed, reasons for cessation eg. problem resolution
Timepoint [6] 422697 0
3 and 6 months post-commencement of the intervention
Secondary outcome [7] 422698 0
What proportion of patients who are initially allocated to the single-session, modified chronic disease self-management program (group 1) choose to participate in the multi-session, goal-directed, chronic disease self-management program after the 3-month wait period?
This will be collected by auditing study records
Timepoint [7] 422698 0
6 months post-commencement of the intervention

Eligibility
Key inclusion criteria
Participants with Long COVID-19 must be over 18 years who have experienced symptoms for 12 weeks or more following a diagnosed or suspected infection with COVID-19. They will need to reside in Australia and be able to communicate in English.
Student participants will be pre-registration health professional students (Dietetics, Occupational Therapy, Paramedicine, Physiotherapy or Social Work) on clinical placement at Monash University.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must have experienced symptoms for 12 weeks or more following a diagnosed or suspected infection with COVID-19.

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)
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This trial design is similar to cross-over design however, it is not in this case as the primary outcome assessment time-point will be at 3 months, prior to this cross-over. This design enables evaluation of research aims related to sustainability (at 6 months) of initial outcomes measured at 3 months and also contrast of rates of uptake of clinical outcomes from the multi-session, goal-oriented, chronic disease self-management approach if it is delivered immediately versus after a 3-month delay.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We sought to calculate the number of participants needed per group in order to identify a standard effect size of that would be the minimum required to justify the difference in cost between the multiple session chronic disease self management (CDSM) and the singles session control group. We anticipated a $1500 additional cost per patient in the multi session CDSM group and that this intervention would need to create 0.03 Quality Adjusted Life Year (QALY) more per patient than the control group in order to fall below the $50,000 per Quality Adjusted Life Year (QALY). Given that natural symptom resolution tends to happen within 12 months, we estimate the difference between groups in health-related quality of life (HRQOL) that we will need to achieve by 3 months assessment will be a 0.12, in order to generate the 0.03 difference per patient in QALY lived required. Further, previous studies of HRQOL in people with chronic disease indicate a standard deviation greater than 0.2 is realistic. We therefor calculate that 63 participants per group will be required to identify a 0.12 difference in health related quality of life (HRQOL) the 3 month follow up, given a common standard deviation of 0.24, a two tailed alpha of 0.05 to achieve a statistical power of 80%. We inflate this number to 76 participants per group to account for a 20% loss to follow up.
The primary analysis will use data collected at 3 months, comparing the primary outcome measure - Global Impression of Change, using linear regression [GIC] (ordinary least squares). The secondary outcomes will be compared at this time between groups using linear regression (ordinary least squares) adjusted for the baseline value of the outcome captured at baseline. The data compared will be scores on the EQ-5D, on the modified YRS-C19 and an estimate of the spending on health. Subsequent analyses will also be conducted to investigate the sustainability of the changes observed at 3 months within Group 2 (group offered 12 sessions of Chronic Disease Management). Changes between the 3 month and 6-month assessment for primary and secondary outcomes will be examined using linear (ordinary least squares) with the data clustered by participant and robust variance estimates employed. As an exploratory analysis, we will examine the impact of commencing the twelve sessions of intervention immediately compared to the group with a 3-month delay (Group 1), change in scores in the primary and secondary outcomes will be compared between Group 1 (6-month and 3-month assessment values) and Group 2 (3-month and baseline assessment values). Exploratory analyses and mechanism of change will be undertaken using data related to therapeutic alliance between the participant and student therapist, participant baseline assessment values and participant intervention and participation measures using pathway analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
5/04/2024
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313931 0
University
Name [1] 313931 0
Monash University
Country [1] 313931 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Room 304
Building G
Peninsula Campus, Monash University
47 - 49 Moorooduc Hwy
Frankston Victoria 3199
Country
Australia
Secondary sponsor category [1] 315799 0
None
Name [1] 315799 0
Address [1] 315799 0
Country [1] 315799 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313076 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 313076 0
Wellington Road
Clayton
Victoria 3800
Australia
Ethics committee country [1] 313076 0
Australia
Date submitted for ethics approval [1] 313076 0
29/05/2023
Approval date [1] 313076 0
Ethics approval number [1] 313076 0

Summary
Brief summary
Long COVID-19 is a multisystemic condition comprising symptoms that follow an acute infection. This research will compare a multi-session, goal-oriented, chronic disease self-management treatment approach compared to a single-session of a modified version of the same approach.
The research questions are:
• What is the effect of providing a multi-session program for people experiencing long COVID-19 compared to a single session of the same program on health outcomes at the 3-months?
• Are these changes sustained at the 6-month follow-up?
• What is the difference in health outcomes between groups at the 6-month follow-up time point?
• How do these health outcomes relate to the perception of the therapeutic relationship from the perspective of both the student and the participant?
Treatment programs and measurements will be delivered by students under the supervision of clinical placement supervisors
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126910 0
Prof Terry Haines
Address 126910 0
Monash University
Room 304
Building G
Peninsula Campus, Monash University
47 - 49 Moorooduc Hwy
Frankston Victoria 3199
Country 126910 0
Australia
Phone 126910 0
+61 3 9902 9409
Fax 126910 0
Email 126910 0
terry.haines@monash.edu
Contact person for public queries
Name 126911 0
Dr Debra Mitchell
Address 126911 0
Room 317
Building G
Peninsula Campus, Monash University
47 - 49 Moorooduc Hwy
Frankston Victoria 3199
Country 126911 0
Australia
Phone 126911 0
+61 3 99044379
Fax 126911 0
Email 126911 0
debra.mitchell@monash.edu
Contact person for scientific queries
Name 126912 0
Prof Terry Haines
Address 126912 0
Monash University
Room 304
Building G
Peninsula Campus, Monash University
47 - 49 Moorooduc Hwy
Frankston Victoria 3199
Country 126912 0
Australia
Phone 126912 0
+61399029409
Fax 126912 0
Email 126912 0
terry.haines@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified outcome measure data will be shared on request
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Data will be made available on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Data will be available to achieve the aims in the approved proposal
How or where can data be obtained?
Data can be obtained by contacting the Principal Investigator, Prof Terry Haines
Terry.haines@monash.edu


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.