None listed
Conditions
Brief summary
Post COVID-19 condition is a debilitating illness with over 200 symptoms across 10 organ systems and is presently impacting millions worldwide. The National Institute for Health and Care Excellence recommends a multidisciplinary treatment approach including person-centred self-management strategies, however evidence for specific programs is lacking. The Take Charge intervention is a person-centred, self-management rehabilitation approach that has been effective in recovery after stroke, but not yet tested in post COVID-19 condition. This study is a prospective, single-centre, parallel, 2 group, mixed methods, randomized controlled trial with embedded process evaluation of the Take Charge intervention in individuals living with post COVID-19 condition. Participants will be at least 18 years of age, have a confirmed diagnosis of post COVID-19 condition with ongoing symptoms, and be known to a hospital clinic for assessment and treatment of patients with post-acute sequelae of COVID-19. The primary outcomes are the Modified COVID-19 Yorkshire Rehabilitation Scale and the COVID-19 Core Outcome Measure for Recovery. The secondary outcomes include physical and self-report measures, and feasibility measures. Qualitative interviews will also be conducted to understand the clinicians’ and participants’ experiences. Statistical analysis will be performed on an intention-to- treat basis using a multivariate mixed-effect linear regression model.
Interventions
A prospective, single-centre, parallel, 2 group, mixed methods, randomized controlled trial with embedded process evaluation of the Take Charge intervention in individuals
living with post COVID-19 condition.
Two 'Take Charge' sessions using a guided workbook with a facilitator trained in the Take Charge approach.
Participants will receive their first Take Charge session within 2 weeks of randomisation followed by a second session 4 weeks later.
Sessions are designed to take up to 60 minutes
A prospective, single-centre, parallel, 2 group, mixed methods, randomized controlled trial with embedded process evaluation of the Take Charge intervention in individuals living with post COVID-19 condition. Two 'Take Charge' sessions using a guided workbook with a facilitator trained in the Take Charge approach. Participants will receive their first Take Charge session within 2 weeks of randomisation followed by a second session 4 weeks later. Sessions are designed to take up to 60 minutes but may finish earlier if the workbook is completed or the participant wishes to stop. Sessions may be extended up to 75 minutes if deemed necessary. The Take Charge sessions are in addition to usual clinic care and any other healthcare the patient may be engaged in.
Sponsors
Flinders Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants will be community living adults aged 18 years or older who have attended the Local Health Network’s PASC clinic and have a confirmed diagnosis of post COVID-19 condition with ongoing symptoms.
Exclusion criteria
Given the low-risk nature of the intervention, the exclusion criteria are limited to significant or imminently life-limiting conditions or the inability to provide informed consent
Outcome results
None listed