Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000077662
Ethics application status
Approved
Date submitted
2/12/2022
Date registered
23/01/2023
Date last updated
26/07/2024
Date data sharing statement initially provided
23/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Taking Charge after COVID-19 a feasibility study: Can outcomes be improved for people with ‘Long COVID’ using a psychologically informed rehabilitation approach?
Scientific title
Taking Charge after COVID-19 a feasibility study: Can outcomes be improved for people with ‘Long COVID’ using a psychologically informed rehabilitation approach?
Secondary ID [1] 308530 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients diagnosed with confirmed long 'COVID-19' 328360 0
Condition category
Condition code
Respiratory 325399 325399 0 0
Other respiratory disorders / diseases
Public Health 325469 325469 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single blinded randomised controlled trial will be conducted to compare between the 'Take Charge program' (the intervention) and Telephone follow-up, if one is better in improving symptoms and quality of life of patients after diagnosed with long COVID. Eligible participants will be community living adults aged 18 years or over who are referred to the Southern Adelaide Local Health Network long COVID clinic and have a confirmed diagnosis of long COVID.
Eligible patients who are randomised to the intervention arm will receive -
Standard clinic care which includes medical, nursing and physiotherapist assessment. If clinically indicated, patients will also be referred to any relevant specialist, occupational therapy, exercise physiology, physiotherapy and/or a specific rehabilitation program. Patients will be followed up based on clinical need in line with current standard practice.
In addition to the abovementioned usual care, patients in the intervention group will receive two 'Take Charge' sessions.
An experienced allied health professional will deliver the intervention face-to-face or using tele-health and schedule two individual consultations with the patients in the intervention group at Flinders Medical Centre in the long COVID clinic.
Total number of participants in the intervention group is 65. For the eligible participants, each session will last approximately 60 minutes, four weeks apart. The health professional will talk with the patients about ‘the big picture’ and work with them to identify some goals for the upcoming months and years. Some people feel very deflated once they are diagnosed with long COVID. However, this is usual and this intervention will focus on what patients can do and on maintaining hope and quality of life. The interventionist will receive training and follow the existing Take Charge manual modified to suit the needs of the Long COVID population.
In consideration of COVID-19 restrictions, the intervention can be adapted for telehealth delivery if required, and the research team has plentiful experience in offering telehealth interventions.
Family members or friends can be present at the patient’s request. A Take Charge illustrated workbook is used to structure the process and help the person consider the future and generate ideas. The booklet remains with the person after the session is completed.
All patients enrolled will receive outcome measures at baseline and at 3 months. The 3-month end point assessment will be performed by a researcher blinded to allocation.
At the end of the study intervention, the research team will conduct ten interviews with experimental intervention participants and ask if the patients are willing to participate. The purpose of the interview is to seek detailed feedback about patients' experiences of the Take Charge program. The interview will take about one hour and be completed either in person or using telehealth according to the patients preference. The patients can decline to participate in an interview or anytime during the interview. Data from the interviews will be audio recorded, professionally transcribed, de-identified and coded in order to categorise and present key themes.
There are no set activities patient’s will be asked to complete during this interval. Patients may set their own activities or targets during the first session using the guided booklet and work on things they deem important during this time however this will be dictated by the individual.
As ‘Take Charge’ is grounded in the patient taking ownership and dictating what they do and when there is no minimum required adherence other than participation in the two sessions. We will take attendance of participation in the two take charge sessions.
Intervention code [1] 324972 0
Lifestyle
Comparator / control treatment
Participants randomised to the control arm will receive - Standard clinic care which includes medical, nursing and physiotherapist assessment supervised by the clinicians from Flinders Medical Centre. If clinically indicated, patients will also be referred to any relevant specialist, occupational therapy, exercise physiology, physiotherapy and/or a specific rehabilitation program at Flinders Medical centre.
All patients in the control group will be followed up based on clinical need in line with current standard practice. In addition, the control group will also receive two phone calls of up to 60 minutes from health professional from Flinders Medical Centre COVID clinic to match the time received by the intervention group. Information on enrolment rates, attendance, participant satisfaction and adverse events will be collected to monitor adherence during the comparator treatment.
The phone calls will be with an allied health staff member or nurse and are designed to simulate the amount of time the intervention group receives and minimise the placebo effect. The content will include general symptom review, check in about any health-related issues the patient wishes to discuss and standardised medical responses to this in line with current recommendations for long COVID. If concerning features are identified in the phone call the patient will be appropriately directed to seek further medical attention – whether it be with a clinic follow up appointment, their GP or emergency etc.
At the end of the study intervention, the research team will conduct five interviews of control group participants and ask if the patients are willing to participate. The purpose of the interview is to seek detailed feedback about patients' experiences of the control intervention program. The interview will take about one hour and be completed either in person or over telehealth according to patient preference. the patients can decline to participate in an interview or anytime during the interview. Data from the interviews will be audio recorded, professionally transcribed, de-identified and coded in order to categorise and present key themes.
Interviews will also be conducted with ten of the experimental group participants, in the same format.
Control group
Active

Outcomes
Primary outcome [1] 338188 0
Modified COVID-19 Yorkshire Rehabilitation Scale (17 items)
Timepoint [1] 338188 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Primary outcome [2] 338190 0
Recovery scale for COVID-19 (1 item)
Timepoint [2] 338190 0
This measure will also be collected at 6 and optional 12 month from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [1] 416434 0
6 minute walk test
Timepoint [1] 416434 0
Baseline, 3-months, immediately post-intervention
Secondary outcome [2] 416448 0
Generalised Anxiety Disorder Assessment GAD-7 (7 items)
Timepoint [2] 416448 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [3] 416449 0
Modified Medical Research Council (MMRC) Dyspnoea Scale (1 item)
Timepoint [3] 416449 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [4] 416451 0
Medical Outcomes Study Short Form 36 (36 items)
Timepoint [4] 416451 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [5] 416452 0
Work Productivity and Activity Impairment Questionnaire (6 items)
Timepoint [5] 416452 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [6] 416453 0
Fatigue severity scale (10 items)
Timepoint [6] 416453 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [7] 416454 0
Survey of work status by collecting data on 3 stages of employment rates and work hours
(1) Pre COVID-19 infection, (2) at time of recruitment and (3) at 3 month follow up.
Timepoint [7] 416454 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [8] 434873 0
Routine clinical observations including postural blood pressure assessed by sphygmomanometer, heart rate, temperature will be measured by thermometer, weight measured using digital weight machine and height. All measurements will be collected at Flinders Medical Centre COVID Clinic in person by a health professional.. These components will be analysed together as a composite set of outcomes.
Timepoint [8] 434873 0
This measure will be collected at the timepoint of 12 weeks following randomisation. All measurements will be collected at Flinders Medical Centre COVID Clinic in person by a health professional..
Secondary outcome [9] 434875 0
Hand grip strength measured using a hand-held dynamometer,
Timepoint [9] 434875 0
Baseline and at 3 months (12 weeks) following baseline measurements.
Secondary outcome [10] 434877 0
One minute sit to stand test
Timepoint [10] 434877 0
Baseline and at 3 months (12 weeks) following collection of baseline measurements.
Secondary outcome [11] 434879 0
Patient Health Questionaire-9 PHQ-9 (10 items)
Timepoint [11] 434879 0
This measure will also be collected at 6 and optional 12 month from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [12] 434881 0
General Self Efficacy Scale (10 items)
Timepoint [12] 434881 0
This measure will also be collected at 6 and optional 12 months from randomisation through survey with method as per participant preference (online or paper based). Participation in the trial will be considered complete at the 6 month time point.
Secondary outcome [13] 437979 0
Qualitative interviews with 10 patients in the experimental intervention group and 5 patients in the control intervention group to understand their experience of receiving the program.
Data will be audio recorded, professionally transcribed and coded in order to categorise and present key themes. Interviews will be conducted by someone external to the trial investigator team.
Timepoint [13] 437979 0
Secondary outcome [14] 437980 0
Qualitative interviews with 10 patients in the experimental intervention group and 5 patients in the control intervention group to understand their experience of receiving the program.
Data will be audio recorded, professionally transcribed and coded in order to categorise and present key themes. Interviews will be conducted by someone external to the trial investigator team.
Timepoint [14] 437980 0
Interviews will be collected following completion of the 12 week collection of surveys and physical outcome measures.
Secondary outcome [15] 437981 0
Qualitative interviews of interventional clinicians for the control and experimental group.
Timepoint [15] 437981 0
Interviews will be collected following completion of the 12 week collection of surveys and physical outcome measures.
Secondary outcome [16] 437982 0
Qualitative interviews of interventional clinicians for the control and experimental group.
Timepoint [16] 437982 0
Following conclusion of active trial participation, once all active interventions complete.

Eligibility
Key inclusion criteria
Eligible participants will be community living adults aged 18 years or over with a confirmed diagnosis of Long COVID. Participants must have attended the Southern Adelaide Local Health Network’s Long COVID clinic.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Live outside of the SALHN region or are medically inappropriate as determined by the multidisciplinary team.

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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation method to be varied block sizes of 2 or 4. The randomisation sequence will be developed by a health and scientific data expert external to the research trial and encoded into the REDCap database for use in the trial. The randomisation sequence will be blinded to researchers involved the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a 18-month study with a sample size of 130 participants. These 130 participants will be randomly allocated to intervention (n=65) or control group (n=65). The sample size is based on data from a similar population of long COVID patients to that seen in the Southern Adelaide Local Health Network long COVID clinic (McFann et al 2021, Reference number 14 in the project protocol attached). A sample size calculation based on this recent study suggests we will need to recruit 54 participants to detect a clinically and statistically significant 30% improvement in the intervention group. Information collected will be entered into a database. Descriptive statistics (mean, standard deviation, range) will be used to test group differences in the primary and secondary outcomes at baseline and 3 month (postintervention). In addition, independent samples t-test to compare means between groups will be used. A statistician in the College of Medicine and Public Health at Flinders University will determine the best approach to analysis of efficacy taking into account distribution of the data and any missing data. Analysis will be conducted in SPSS.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/02/2023
Actual
22/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
74
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23670 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 39096 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 312774 0
Charities/Societies/Foundations
Name [1] 312774 0
Flinders Foundation
Country [1] 312774 0
Australia
Funding source category [2] 312791 0
Charities/Societies/Foundations
Name [2] 312791 0
Hospital Research Foundation
Country [2] 312791 0
Australia
Primary sponsor type
University
Name
Department of Rehabilitation, Aged & Palliative Care, Flinders University
Address
Flinders Medical Centre Rehab building, FMC 4W209
Medical sciences road, Bedford Park, SA 5042
Country
Australia
Secondary sponsor category [1] 314424 0
None
Name [1] 314424 0
Address [1] 314424 0
Country [1] 314424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312068 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 312068 0
Ethics committee country [1] 312068 0
Australia
Date submitted for ethics approval [1] 312068 0
28/11/2022
Approval date [1] 312068 0
12/12/2023
Ethics approval number [1] 312068 0
OFR Number: 219.22 HREC Reference number: LNR/20/SAC/203

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

Contacts
Principal investigator
Name 123350 0
Dr Subbuh Luker
Address 123350 0
Department of Rehabilitation, Aged & Palliative Care, College of Medicine and public Health
Flinders University
Office: Level 4, Rehab building, Flinders Drive, Flinders Medical Centre, Bedford park, SA 5042
Country 123350 0
Australia
Phone 123350 0
+61430777295
Fax 123350 0
Email 123350 0
subbuh.luker@sa.gov.au
Contact person for public queries
Name 123351 0
Subbuh Luker
Address 123351 0
Department of Rehabilitation, Aged & Palliative Care, College of Medicine and public Health
Flinders University
Office: Level 4, Rehab building, Flinders Drive, Flinders Medical Centre, Bedford park, SA 5042
Country 123351 0
Australia
Phone 123351 0
+61430777295
Fax 123351 0
Email 123351 0
subbuh.luker@sa.gov.au
Contact person for scientific queries
Name 123352 0
Subbuh Luker
Address 123352 0
Department of Rehabilitation, Aged & Palliative Care, College of Medicine and public Health
Flinders University
Office: Level 4, Rehab building, Flinders Drive, Flinders Medical Centre, Bedford park, SA 5042
Country 123352 0
Australia
Phone 123352 0
+61430777295
Fax 123352 0
Email 123352 0
subbuh.luker@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As long COVID data may have sensitive information about patients day to day life style such as work details which may have risks of confidentiality and privacy breaches and the violation of other legitimate private interests, such as commercial interests. For this reason, data will not be available to others including data dictionaries.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22368Study protocol    385073-(Uploaded-13-05-2024-12-16-18)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22368[Marked for deletion] Study protocol    385073-(Uploaded-13-05-2024-12-16-18)-Study-related document.pdf

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.