Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000719730
Ethics application status
Approved
Date submitted
13/04/2022
Date registered
19/05/2022
Date last updated
19/05/2022
Date data sharing statement initially provided
19/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and patient-acceptability of a novel multidisciplinary COVID-19 Recovery Service in the Australian Capital Territory.
Scientific title
The feasibility and patient-acceptability of a novel multidisciplinary COVID-19 Recovery Service in the Australian Capital Territory: an observational study
Secondary ID [1] 306935 0
Nil known
Universal Trial Number (UTN)
U1111-1277-1656
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 326043 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323352 323352 0 0
Other physical medicine / rehabilitation
Respiratory 323511 323511 0 0
Other respiratory disorders / diseases
Infection 323512 323512 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As ethical approval has been obtained, with a waiver of patient consent, all participants receiving the program will be included in the study.

Patients will be referred to the program via GP or community referral pathways, if they are experiencing residual problems as a result of a previous COVID-19 infection. There is no specific timeframe stipulated, and the inclusion will be broad.

Patients referred to the program will undergo comprehensive medical assessment and screening for their suitability to participate in rehabilitation. Where indicated, this will include assessment of the patient’s cardiopulmonary exercise capacity (VO2max and anaerobic threshold), as well as lung function testing (spirometry, maximum inspiratory pressure). Such tests have recently been shown to be safe and valuable in patients following COVID-19. The medical specialist will then advise the rehabilitation team of any specific exercise limitations based on this testing (e.g. SpO2 targets). This screening could take up to 2 - 3 hours, depending on the patient's need for rest breaks etc.

Following a thorough patient-tailored individual assessment, the rehabilitation program received by a patient in the service could include any or all of the following, depending on the patient’s needs:
-Specialized care planning and care coordination (including social work input where relevant)
-Goal based short term rehabilitation interventions (e.g. supervised individually prescribed exercise therapy; inspiratory muscle training; functional retraining for activities of daily living)
-Education to facilitate self-management
-Group rehabilitation including pulmonary rehabilitation and semi supervised group therapies
-Telehealth interventions as an adjunct to usual therapy where clinically safe and effective
-Where necessary, home-based assessment and treatment for goals relating to essential activities of daily living
-Individual therapy sessions involving clinical psychology, neuropsychology, dietetics, speech pathology etc as required

The frequency and duration of sessions will vary between patients depending on their needs and services provided. This could range from 1 or 2 sessions of 30 - 60 minutes per week for a short period (e.g. 2 months), to several sessions per week for 6 months. This study will only analyse the first 6 months of the clinic's operation (June - December 2022) so this will limit the observation period, and it is highly likely that some patients will continue care beyond 6 months.

Only a subgroup of participants will be included in the patient acceptability component of this study. All patients completing the study will be invited to participate in the acceptability survey and focus groups, but as participation is voluntary, not all may participate in this aspect. For the interviews, the first 10 participants to consent will be included, and ongoing sequential recruitment will only occur if quantitative analysis indicates that saturation of themes has not yet occurred. It is possible that a total of 10 - 15 patients may be required for interviews. Once saturation of themes is noted, recruitment to the interviews will cease, but acceptability surveys will still be offered to all participants who complete the program within the first 6 months.

For the observational study (6 months), the data collected from the records will include the patient's age, sex, date of birth, COVID diagnosis and admission details (if relevant), past medical history, and attendance at clinic appointments (as outlined above), or non-attendance. Any deaths, re-hospitalisations or adverse events will also be recorded. All data will be directly collected from the program records, and participants are not actively involved.
Intervention code [1] 323378 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331087 0
Feasibility will be treated as a composite outcome.

Feasibility data, obtained from the clinic records, will include:
- Number of patients completing an initial assessment
- Time between referral and completion of initial assessment
- Number and type of sessions attended per patient
- Actual completion of planned sessions (as a percentage of planned sessions), including frequency of unexplained non-attendance
- Safety: occurrence of adverse events (e.g. deterioration in presenting symptoms during course of program; worsening of physiological status during exercise; injury, serious disability or death during rehabilitation activities)
- Number of patients completing the program
- Size of waiting list across the life of the program (June – December 2022)

The clinic will be considered feasible a priori if it meets the following criteria:
- More than 75% of patients attend a minimum of 75% of planned sessions
- More than 75% of patients complete the individually prescribed rehabilitation program
- Safety: Adverse event rate will be < 10% of patients experiencing any minor adverse events (and no serious disability or death occurring as a direct result of rehabilitation activities)
Timepoint [1] 331087 0
On completion of program (e.g. 6 months)
Primary outcome [2] 331088 0
Patient acceptability will be treated as a composite outcome.

Patient acceptability will be captured through voluntary completion of:
- Acceptability survey (bespoke design, based on the principles previously described by Sekhon et al) completed by participants on completion of the program. This will involve a short 1 page written survey (provided) which will take less than 10 minutes to complete.
- Individual patient interviews conducted by a researcher not involved in delivery of the program (TB). This strategy should minimize bias in patient responses. Participants will be required for up to 60 minutes to answer open-ended questions, and their responses will be audio-recorded and transcribed. The interviews will be conducted either face to face or through a virtual platform, depending on the participant's preferences and COVID restrictions in place a the time.
Timepoint [2] 331088 0
On completion of program (e.g. 6 months)
Secondary outcome [1] 408684 0

- Inspiratory muscle strength (maximum inspiratory pressure), measured with a hand held manometer)
Timepoint [1] 408684 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [2] 408685 0
- Physical strength (composite outcome): quadriceps, biceps and grip dynamometry; Oxford scale globally
Timepoint [2] 408685 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [3] 408686 0
- Blood pressure, using an electronic sphygmomanometer
Timepoint [3] 408686 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [4] 408687 0
- Exercise tolerance: 6 Minute Walk Test
Timepoint [4] 408687 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [5] 408688 0
- Quality of life: EQ-5D scale
Timepoint [5] 408688 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [6] 408690 0
- Fatigue: Brief Fatigue Inventory
Timepoint [6] 408690 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [7] 408691 0
- Depression and Anxiety Stress Scale: DASS-21
Timepoint [7] 408691 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [8] 408692 0
- Return to Work / Occupation (participant-reported)
Timepoint [8] 408692 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [9] 408693 0
- Disability: PICUPS Screening Tool (PICUPS or PICUPS Community version)
Timepoint [9] 408693 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [10] 409441 0
Breathlessness: Borg scale of breathlessness (patient self reported, scale from 0 to 10)
Timepoint [10] 409441 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [11] 409442 0
Oxygen saturation (based on need identified in medical screening), using a pulse oximeter
Timepoint [11] 409442 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [12] 409443 0
Functional measure of independent mobility: Timed Up and Go Test
Timepoint [12] 409443 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session
Secondary outcome [13] 409444 0
Functional measure of independent mobility: 1 minute Sit to Stand
Timepoint [13] 409444 0
If relevant, on commencement and completion of program (variable due to individualised nature of therapy), during final face-to-face session

Eligibility
Key inclusion criteria
This observational study will analyze data routinely collected as part of the delivery of the ACT’s new multidisciplinary COVID-19 recovery clinic. All patients presenting for assessment in the clinic (June – December 2022), who meet the criteria below, will be eligible for inclusion.
• Referral via medical specialist or general practitioner with a history of presumed or actual COVID-19, and ongoing post-acute sequelae impacting on activities of daily living
• Aged 16 years or over
• ACT residents
• Willingness and capacity to participate in assessment and therapy, either in an outpatient setting at University of Canberra Hospital, OR in the patient’s own home if deemed appropriate by the assessment team
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size
The sample size for this study is not pre-determined due to the pragmatic nature of this observational study. Rather, we will capture all patients admitted to the service between 1st June 2022 and 31st December 2022. We anticipate this will include between 50 and 100 patients, depending on demand. If there is excessive demand for the service, this study will capture the first 100 patients admitted to the service during this time frame.

For the patient acceptability interviews, we anticipate 10-15 patients will be required to achieve data saturation, but the process will continue until no new themes are identified in participant feedback.

Statistical analysis:

For quantitative analysis, all routinely collected patient data will be entered into a patient data management system (REDCAP) hosted through the University of Canberra. The data will be deidentified from the point of data entry, and only the primary research team will have access to this data, with password-protection limiting access. Where appropriate, data will be normalized to adjust for age and sex (e.g. maximum inspiratory pressure values). Descriptive statistics will be used to analyze the primary outcome data, and feasibility will be calculated (e.g. percentage of completed sessions relative to planned sessions).

If sample size allows for the secondary outcomes, regression analysis may be used to identify relationships between demographic data (e.g. hospitalization with COVID-19, or time since infection) and outcomes in the service (e.g. functional tests like 6MWT). Analysis will be conducted using the R statistics program in collaboration with an experienced health statistician at the University of Canberra.

For qualitative analysis, the interviews will be transcribed verbatim and analysed using the framework described by Braun and Clark. Themes will be identified and synthesized, using patient voice as much as possible to describe the experience and acceptability of the rehabilitation service. Patients will be de-identified in this analysis, but will be potentially re-identifiable to the research team. Results of this analysis will be shared with participants on request.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 22198 0
The University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research - Bruce
Recruitment postcode(s) [1] 37353 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 311251 0
Hospital
Name [1] 311251 0
Canberra Health Services
Country [1] 311251 0
Australia
Funding source category [2] 311252 0
University
Name [2] 311252 0
University of Canberra
Country [2] 311252 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Guraguma Street, Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 312610 0
Hospital
Name [1] 312610 0
University of Canberra Hospital
Address [1] 312610 0
Guraguma Street, Bruce ACT 2617
Country [1] 312610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310766 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 310766 0
Ethics committee country [1] 310766 0
Australia
Date submitted for ethics approval [1] 310766 0
03/03/2022
Approval date [1] 310766 0
25/03/2022
Ethics approval number [1] 310766 0
2022/ETH00369

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

Contacts
Principal investigator
Name 118786 0
A/Prof Bernie Bissett
Address 118786 0
UCH | Office 8, Level 2, Guraguma Street, Bruce ACT 2617
Country 118786 0
Australia
Phone 118786 0
+61 404319234
Fax 118786 0
Email 118786 0
[email protected]
Contact person for public queries
Name 118787 0
Bernie Bissett
Address 118787 0
UCH | Office 8, Level 2, Guraguma Street, Bruce ACT 2617
Country 118787 0
Australia
Phone 118787 0
+61404319234
Fax 118787 0
Email 118787 0
[email protected]
Contact person for scientific queries
Name 118788 0
Bernie Bissett
Address 118788 0
UCH | Office 8, Level 2, Guraguma Street, Bruce ACT 2617
Country 118788 0
Australia
Phone 118788 0
+61 404319234
Fax 118788 0
Email 118788 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
Not appropriate given sensitive health information and ethics limitations


What supporting documents are/will be available?




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.