Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000698976
Ethics application status
Approved
Date submitted
11/06/2020
Date registered
23/06/2020
Date last updated
16/06/2024
Date data sharing statement initially provided
23/06/2020
Date results provided
16/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Maintaining the health of people with and without COVID-19 during isolation
Scientific title
Does a Health Package of exercise and advice on anxiety management and nutrition improve outcomes and experiences of patients with COVID-19 isolated at home or Special Health Accommodation under the care of Royal Prince Alfred (RPA) Virtual Hospital and those without COVID-19 quarantined in Sydney Local Health District Special Health Accommodation?: a pilot trial.
Secondary ID [1] 301490 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Isolation for COVID-19 317822 0
Isolation for quarantine in non-COVID-19 317823 0
Anxiety 317921 0
Condition category
Condition code
Public Health 315881 315881 0 0
Health promotion/education
Infection 315957 315957 0 0
Other infectious diseases
Mental Health 315958 315958 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be provided with a Health Package either via paper or email, depending on the participant's access to technology, place of isolation and participant preference. The Health Package will include:
• A physical activity/exercise program (via an exercise app [PhysiApp] or paper-based) which will be varied according to the participants’ reported exercise history, symptoms, clinical signs and fatigue levels
• Anxiety management techniques
• A guide to healthy eating, using food commonly found in the pantry and/or easily accessible for those at home or healthy food choice options (via UberEats or requests to SLHD services) for those isolated in hotels
The study coordinator will meet virtually with the participant via phone or videoconference to discuss the elements of the Health Package and how it will be used.
Participants will be asked to engage with the program for two weeks or until discharge (whichever comes first). For non-COVID-19 participants, discharge will be based on a negative swab on day 10 and day 13 of quarantine. For COVID-19 participants discharge will depend on two consecutive negative swabs after 14 days of isolation. The actual days of enrolment in the program will be documented.

Program Details
Exercise program
The exercise program will be prescribed by a physiotherapist or accredited exercise physiologist who are highly experienced in exercise prescription for people with chronic conditions,especially lung disease. The exercise program will be a ‘light’ exercise program, designed to help participants keep active. It is NOT a fitness training program. Participants will be screened by the exercise physiologist or physiotherapist using a short questionnaire (Adult Pre-Exercise Screening System [APSS] (APSS 2019) to determine suitability for exercise, and the presence of any cardiovascular or musculoskeletal precautions or contraindications to exercise. The screening will be done by telephone or videoconference. A script for the screening call will be followed. In addition, the participant’s medical record will be reviewed for any past or current clinical problems that may affect the exercise prescription.

The exercises will focus on activities of daily living and will be exercises that can be easily performed at home or in a hotel room, such as walking around the room, sit-to-stand from a chair, squats, heel raises, wall push-ups, arm exercises with light hand weights using cans of food or bags of rice or bottles filled with water, or resistance bands (provided by SLHD), and flexibility exercises. Exercise programs will be individually tailored based on a person’s reported usual physical activity level, measured using the APSS. All exercise programs are intended to be completed at a ‘light intensity’ which is indicated by self-report of ‘very, very slight/light’ to ‘slight/light’ breathlessness or perceived exertion during exercise i.e. 0.5 to 2 out of 10 on the Modified Borg Scale (Borg 1985). A decision tree for determining exercise level and adjusting exercise level will be used. The duration and frequency of exercise will depend on the participant's health status and previous exercise history. A minimum of 20 minutes exercise per day will be prescribed, up to a maximum of 45 minutes per day. Exercise will be able to be completed in in short bouts of at least 10 minutes duration, if necessary.

The exercises will be provided via exercise software (PhysiTrack)(https://www.physitrack.com/) with end-to- end encryption, which allows for real time exercise prescription, modification, and monitoring. An email or text message will be sent directly to the participant, which will prompt him/her to access their exercise program by either downloading a free PhysiApp or via a link to their web browser. The software includes videos, pictures and written instructions of how to perform the exercise program safely. A downloadable PDF or printed version of the exercise program will also be provided, if required.

Anxiety management
Participants will be provided with information on how to practice anxiety management techniques such as:
• Breathing control
• Visualisation of a calm place
• Relaxing muscles
• Counting
• Staying present – e.g mindfulness
• Distraction techniques
• Grounding techniques
This information will be provided in the Health Package booklet at baseline. Links to appropriate websites for anxiety reduction will also be provided.
Escalation procedure: If a participant is distressed due to anxiety, stress, panic or depression they will be asked to contact the staff managing their care and will be referred to a psychologist.

Nutrition advice
Advice on healthy eating will be provided in the Health Package booklet (prepared specifically for this study) at baseline. For those participants isolated at home the information will include how to use pantry staples to prepare simple and economical healthy meals with a focus on foods supporting immune function. For those participants isolated in a health hotel the information will include advice on healthy meal choices from SLHD services and healthy ‘buy-in’ options from UberEats.

The exercise physiologist or physiotherapist will contact the participants via telephone or videoconference every 2-3 days. At these contact calls a checklist will be completed of the participant's reported exercise sessions over the previous 2-3 days and whether they have used any of the anxiety management techniques or the advice regarding healthy eating. Any barriers to exercise, anxiety management or healthy diet will be discussed and strategies to overcome such barriers will be implemented where possible.
Intervention code [1] 317799 0
Prevention
Intervention code [2] 317800 0
Lifestyle
Intervention code [3] 317868 0
Treatment: Other
Comparator / control treatment
There is no comparator control.. Both the COVID-19 positive group and the non-COVID group in quarantine will receive the same intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324089 0
Anxiety/ Depression Screening Tool (DASS-21) (Henry et al 2015).
Timepoint [1] 324089 0
At enrolment and following completion of the intervention.
Primary outcome [2] 324091 0
Participant experience measure:: Participants will be asked to fill in a short questionnaire to report their experiences of the program. The questionnaire has been designed specifically for this study and was based on the NSW Ministry of Health/Agency of Clinical Innovation criteria for evaluating patient reported experience of care..
Timepoint [2] 324091 0
Immediately following completion of the intervention
Secondary outcome [1] 383732 0
Fatigue Screening Tool (Brief Fatigue Inventory) (Mendoza et al, 1999)
Timepoint [1] 383732 0
At enrolment and immediately following completion of the intervention
Secondary outcome [2] 383733 0
Quality of life (EuroQol-5D-5L)
Timepoint [2] 383733 0
At enrolment and immediately following completion of the intervention

Eligibility
Key inclusion criteria
There will be two groups of people included in the study:
1) people categorised as ‘low risk’ COVID-19* being isolated at home or in a health hotel and managed by
rpavirtual. Those who have been categorised as moderate or high risk at any stage will not be included.
2) people without COVID-19 being quarantined in hotels and managed by SLHD staff and services.
*Low risk: category: patient with no symptoms; low grade fever <38; mild cough and upper respiratory tract symptoms; no breathlessness

Inclusion criteria: Males and females aged 18 years and older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: COVID-19 patients categorised as medium or high risk; diagnosis of a psychotic disorder; comorbidities that would preclude involvement in a remotely monitored exercise program; unable to read or understand English; unable to provide consent either written or verbal.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed using Statistical Package for Social Sciences (SPSS) (Chicago, IL, USA). Analysis will include paired comparisons of outcome measures before and at completion of the Health Package program using student paired t-tests. If participants complete less than 14 days in the program, this will be accounted for in the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/06/2020
Date of last participant enrolment
Anticipated
30/11/2020
Actual
1/03/2022
Date of last data collection
Anticipated
16/12/2020
Actual
1/03/2022
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16872 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 30522 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 305929 0
Hospital
Name [1] 305929 0
Royal Prince Alfred Hospital, Sydney Local Health District
Country [1] 305929 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hopsital
Address
Missenden Road, Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 306388 0
None
Name [1] 306388 0
None
Address [1] 306388 0
Not applicable
Country [1] 306388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306177 0
Sydney Local Health District-RPAH zone
Ethics committee address [1] 306177 0
Ethics committee country [1] 306177 0
Australia
Date submitted for ethics approval [1] 306177 0
04/05/2020
Approval date [1] 306177 0
20/05/2020
Ethics approval number [1] 306177 0
X20-0174 - 2020/STE01716

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

Contacts
Principal investigator
Name 102978 0
Prof Jennifer Alison
Address 102978 0
Sydney School of Health Sciences, Faculty of Medicine and Health
The University of Sydney
Sydney, NSW 2006
Country 102978 0
Australia
Phone 102978 0
+61 414300416
Fax 102978 0
not applicable
Email 102978 0
[email protected]
Contact person for public queries
Name 102979 0
Jennifer Alison
Address 102979 0
Sydney School of Health Sciences, Faculty of Medicine and Health
The University of Sydney
Sydney, NSW 2006
Country 102979 0
Australia
Phone 102979 0
+61 414300416
Fax 102979 0
not applicable
Email 102979 0
[email protected]
Contact person for scientific queries
Name 102980 0
Jennifer Alison
Address 102980 0
Sydney School of Health Sciences, Faculty of Medicine and Health
The University of Sydney
Sydney, NSW 2006
Country 102980 0
Australia
Phone 102980 0
+61 414300416
Fax 102980 0
not applicable
Email 102980 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
Individual data will only be available if there is subsequent ethics approval for data sharing


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8204Informed consent form  [email protected]
8205Ethical approval  [email protected]



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.