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Trial registered on ANZCTR


Registration number
ACTRN12620000443998p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2020
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Home rehabilitation for people with COVID-19: Implementing telehealth approaches to care
Scientific title
Home telerehabilitation for people with COVID-19: Implementing telehealth approaches to care and its effect on reintegration into the community
Secondary ID [1] 300885 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 316820 0
Requiring home rehabilitation service 316912 0
Condition category
Condition code
Public Health 315028 315028 0 0
Health service research
Physical Medicine / Rehabilitation 315039 315039 0 0
Other physical medicine / rehabilitation
Infection 315087 315087 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this study is to evaluate the efficacy and efficiency of two telerehabilitation interventions. The intervention consists of a rehabilitation intervention which focuses more on participation in usual activities and is offered via a coaching model to a virtual group of people. The intervention components are: identifying patient goals with therapist (1:1); and participation in virtual groups (up to 4 participants per session) with physiotherapist and occupational therapists which focus on increasing participation in life roles and usual activities.
The 1:1 session will last for approximately 45 minutes and will be followed by commencement of group sessions within 5 days.
Groups adopt a coaching model where the therapist talks about common challenges, facilitates discussion and sharing of experiences and ideas and the group brainstorm and plan next steps together. The group sessions will last approximately 45 minutes and will be delivered 3 times per week for up to 4 weeks.
Adherence will be measured using attendance logs.

Intervention code [1] 317211 0
Rehabilitation
Intervention code [2] 317246 0
Treatment: Other
Comparator / control treatment
The control/ usual care group consists of a traditional model which is predominantly focused on improving physical function and is offered as usual care by the home rehabilitation service. The intervention components are: patient goals identified with therapist (1:1); input as required from physiotherapist, occupational therapist and allied health assistants; telehealth consultations focused on improving physical function through exercise and modifying activities of daily living to enhance independence.
The 1:1 session will last for approximately 45 minutes and will be followed by commencement of therapy sessions within 5 days.
The therapy sessions will last approximately 45 minutes and will be delivered 3 times per week for up to 4 weeks. The sessions will consist of low to moderate intensity exercises (such as functional activities, or sit-to stand exercises) and are monitored by physiotherapist, No group sessions are planned for participants in the standard care arm.
Adherence will be measured using attendance logs.
Control group
Active

Outcomes
Primary outcome [1] 323334 0
Integration to community as measured on the Reintegration to Normal Living Index (RNLI) - A 11-item questionnaire-based instrument that measures the degree to which individuals achieve reintegration into normal social activities (such as recreation, movement in the community, and interaction in family or other relationships).
Timepoint [1] 323334 0
Baseline,
Three (3) months following baseline assessment.
Secondary outcome [1] 381599 0
Level of frailty as identified on the FRAIL scale - A five-question test that can increase the identification of frailty without a face-to-face examination.
Timepoint [1] 381599 0
Baseline,
Three (3) months following baseline assessment.
Secondary outcome [2] 381600 0
Quality of life as measures on the EQ-5D – a five-dimensional questionnaire used for measuring health-related quality of life for the estimation of quality-adjusted life years within economic evaluations.
Timepoint [2] 381600 0
Baseline,
Three (3) months following baseline assessment.
Secondary outcome [3] 381601 0
Functional Independence Measure
Timepoint [3] 381601 0
Baseline,
Three (3) months following baseline assessment.
Secondary outcome [4] 381603 0
Average cost of services/intervention delivered per participant, calculated based on the purchase price of telehealth hardware and therapist time for each client (including set up time).
Timepoint [4] 381603 0
Baseline,
Three (3) months following baseline assessment.
Secondary outcome [5] 381605 0
Adverse events such as falls assessed by observation during therapy session or self-reports.
Timepoint [5] 381605 0
Three (3) months from baseline.
twelve (12) months from baseline.
Secondary outcome [6] 381724 0
Re-admissions as assessed by checking of participant medical records.
Timepoint [6] 381724 0
Three (3) months from baseline.
twelve (12) months from baseline.

Eligibility
Key inclusion criteria
Any person aged 18 or older, confirmed with COVID-19 referred to home rehabilitation services delivered at Flinders medical Centre through the division of rehabilitation, aged and palliative care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prospective participants are excluded from the study if they decline the offer to participate in the study experimental arm.

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 concealment will be done by using sequentially numbered opaque, sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using an online computer randomisation software program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the Australian study published by Fairhall et al. (2011) which reported data on 181 frail older people who completed the Reintegration to Normal Living Index it was calculated that a sample size of 52 participants (26 per group) would be required. This is based on a mean of 22.2 and standard deviation of 4.31 in recently discharged frail older adults with alpha 0.05 and power at 80%. This study will allow for 10% drop out and therefore recruit 58 participants.

Standard descriptive statistics such as mean and SD or median and range for continuous variables and proportions for categorical variables will be reported, as well as a comparison of means and proportions using t-tests, chi-square tests or fishers exact test as appropriate . Regression analyses where the independent variable will be the allocated condition, and the dependent variable will be the outcomes following intervention (such as FIM score) will be used.

Recruitment data will be reported descriptively. Attendance (in rehabilitation sessions) data will be analysed descriptively in order to explore the number of sessions attended by participants. Characteristics of participants will be presented in a table. Process information (such as intervention processes), information about the telehealth equipment used and the need for technical support) will be presented narratively.

Costs will be calculated based on the costs of telehealth hardware for each person and the costs of providing the intervention for each participant. Staff time based on the time spent with each client and costs and hourly therapist wages will also be calculated. This information is not intended to provide a definitive cost of providing the intervention but will inform the larger planned study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16180 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 29723 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305338 0
University
Name [1] 305338 0
Flinders University
Country [1] 305338 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Division of Rehabilitation, Aged and Palliative Care
Flinders Drive
Bedford park, SA, 5042
Country
Australia
Secondary sponsor category [1] 305705 0
None
Name [1] 305705 0
Address [1] 305705 0
Country [1] 305705 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305671 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 305671 0
Ethics committee country [1] 305671 0
Australia
Date submitted for ethics approval [1] 305671 0
02/04/2020
Approval date [1] 305671 0
Ethics approval number [1] 305671 0

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

Contacts
Principal investigator
Name 101170 0
Prof Maria Crotty
Address 101170 0
Division of Rehabilitation, Aged and Palliative Care; Flinders Medical Centre,
Flinders Dr,
Bedford Park SA 5042
Country 101170 0
Australia
Phone 101170 0
+61 8 8404 2232
Fax 101170 0
Email 101170 0
Maria.Crotty@flinders.edu.au
Contact person for public queries
Name 101171 0
Kate Laver
Address 101171 0
Division of Rehabilitation, Aged and Palliative Care; Flinders Medical Centre,
Flinders Dr,
Bedford Park SA 5042
Country 101171 0
Australia
Phone 101171 0
+61 8 7221 8335
Fax 101171 0
Email 101171 0
kate.laver@flinders.edu.au
Contact person for scientific queries
Name 101172 0
Maria Crotty
Address 101172 0
Division of Rehabilitation, Aged and Palliative Care; Flinders Medical Centre,
Flinders Dr,
Bedford Park SA 5042
Country 101172 0
Australia
Phone 101172 0
+61 8 8404 2232
Fax 101172 0
Email 101172 0
Maria.Crotty@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
in order to maintain the confidentiality of the participants, personal identifying information will not be available at data analysis and only group level results will be published/ disseminated.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7466Study protocol  miia.rahja@flinders.edu.au 379528-(Uploaded-30-03-2020-14-27-09)-Study-related document.docx



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.