Dataset Information

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.

ABSTRACT:

SUBMITTER: McGregor G

PROVIDER: S-EPMC7785779 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.

McGregor Gordon G Sandhu Harbinder H Bruce Julie J Sheehan Bartholomew B McWilliams David D Yeung Joyce J Jones Christina C Lara Beatriz B Smith Jessica J Ji Chen C Fairbrother Elaine E Ennis Stuart S Heine Peter P Alleyne Sharisse S Guck Jonathan J Padfield Emma E Potter Rachel R Mason James J Lall Ranjit R Seers Kate K Underwood Martin M

Trials 20210106 1

<h4>Objectives</h4>The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge.<h4>Trial design</h4>Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded pro ...[more]

PMID: 33407804

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Project description:BackgroundThis qualitative evaluation was embedded in the Rehabilitation Exercise and psycholoGical support After COVID-19 InfectioN (REGAIN) study, a randomised controlled trial (RCT) for those with post-COVID-19 condition ('long COVID') after hospital admission for COVID-19, comparing weekly home-based, live online supervised group exercise and psychological support sessions with 'best practice usual care' (a single session of advice).ObjectiveTo increase our understanding of how and why the REGAIN programme might have worked and what helped or hindered this intervention.DesignA qualitative evaluation which utilised interviews with participants and practitioners delivering the intervention. Framework and thematic analysis were used to analyse the findings.SettingEngland and Wales, UK.ParticipantsAdults discharged from National Health Service (NHS) hospitals at least 3 months previously after COVID-19, with ongoing physical and/or mental health sequelae.ResultsTwenty intervention participants, 20 control participants and five practitioners were interviewed.The themes from the group support sessions were: (1) you are not alone; (2) sharing experiences and addressing worries; (3) gaining new perspectives; (4) hope for progression; (5) peer support and bonding; (6) integration of facilitation skills; (7) modified activity pacing and goal setting, and (8) giving participants structure. The themes from group exercise were: (1) monitoring and modification of the online exercise; (2) catering for differing abilities; (3) feeling safe and confident to exercise; (4) progression of fitness; (5) optimal timing in the recovery trajectory; (6) group effect; (7) initial apprehension about exercise group; (8) gauging exercise capabilities; (9) translating exercises into life; and (10) on-demand supplementary videos. The 1:1 consultation sessions revealed patients needed to tell their stories.ConclusionBeing listened to and being understood by someone 'who got it' was very important to people with post-COVID-19 condition. The group sessions of both exercise and psychological support were valued by participants, working together, and learning from each other in the face of a new disease within a global pandemic.

Project description:ObjectivesPrimary objective: To determine the efficacy of a candidate antiviral on time to virological cure compared to standard of care within 14 days of randomisation Secondary objectives: • To determine the safety of the antiviral • To determine the clinical benefit of the antiviral over placebo according to the WHO 7-point ordinal scale • To determine the clinical benefit of the antiviral over placebo on time to resolution of clinical symptoms • To determine the effect of the antiviral over placebo on biomarkers of inflammation and immune activation TRIAL DESIGN: This is a multi-centre, triple-blind, randomised placebo controlled phase II, 2-arm trial with parallel-group design with allocation ratio 1:1.ParticipantsInclusion Criteria: • Provision of informed consent by the participant • Age ≥18 years • Confirmed SARS-CoV-2 by nucleic acid testing in the past 5 days • COVID-19 related symptom initiation within 5 days • Female patients of childbearing potential must have a negative pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.Exclusion criteria• Known allergy to the study medication • Is on another clinical trial investigating an antiviral treatment for COVID-19 • Pregnancy • Patients with severe hepatic dysfunction equivalent to Grade C in the Child-Pugh classification • Patients with renal impairment requiring dialysis • Is deemed by the Investigator to be ineligible for any reason Participants will be recruited from, and the study visits will take place at Alfred Hospital, Monash Health, Austin Health in Victoria, Australia for hospitalised participants as well as recruitment in the community in participants homes for eligible people not requiring hospitalisation.Intervention and comparatorThe first candidate antiviral is favipiravir Arm 1: Favipiravir 1800 mg favipiravir BD on Day 1 followed by 800 mg BD favipiravir for the next 13 days. Arm 2: Placebo MAIN OUTCOMES: Primary outcome: Time to virological cure as defined by 2 successive throat (or combined nose/throat) swabs negative for SARS-CoV-2 by nucleic acid testing during the 14 days after enrolment.RandomisationRandomisation performed at the Alfred Hospital Clinical Trials Pharmacy using computer generated block-randomisation lists with 6 participants per block. Within each block half of the participants will be randomised to the candidate antiviral and the other half to placebo. Randomisation is stratified by study site, with participants enrolled in the community considered as a study site.Blinding (masking)Study participants, study investigators and the study statistician will be blinded to treatment allocation.Numbers to be randomised (sample size)The study aims to recruit 190 people (95/arm) with the first candidate antiviral favipiravir TRIAL STATUS: Protocol version 2.0 Dated 31-Jul-2020. Recruitment will take place between July 2020 and December 2020.Trial registrationclinicaltrials.gov NCT04445467 First posted 24-Jun-2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Project description:ObjectivesComparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionals TRIAL DESIGN: Single centre, 2-arm, double-blind randomised (ratio 1:1) placebo-controlled trial PARTICIPANTS: Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study. Exclusion criteria include: History of COVID -19 virus infection, clinical symptoms such as fever, nausea, dyspnea and myalgia in the past two months, history of underlying diseases hypersensitivity to hydroxychloroquine and G6PD enzyme deficiency.Intervention and comparatorIntervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical.Control groupplacebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy). The dosage is two tablets daily, once a week for one to three months (based on the duration of the Coronavirus epidemic in Tehran).Main outcomesConfirmed COVID-19 virus infection using Polymerase chain reaction (PCR) test is the primary outcome. The time period for measuring the primary outcome is any infection within the trial period up to one month after taking the last dose.RandomisationThe randomized block allocation method was developed using Stata version 15 software by an independent researcher, using a block size of six. Allocation to the two treatment groups will be conducted by this researcher using paper labels (random 10-digit codes) in a 1:1 ratio t The labels will be attached to the drug packages in order of randomization. Drug packages will be arranged in a box according to the randomization list.Blinding (masking)Participants and caregivers are blinded to group assignment and the data will be analyzed by an independent statistical expert who is unaware of the treatment allocation.Numbers to be randomised (sample size)A total of 282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the placebo control group TRIAL STATUS: The protocol version number is 99-1-101-47091 and the approval ID is IR.TUMS.VCR.REC.1399.001 and recruitment began April 7, 2020, and is anticipated to be complete by August 7, 2020.Trial registrationThe name of the trial register is Iranian registry of clinical trial (IRCT), registration number is IRCT20120826010664N6, date of trial registration is April 7, 2020, FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Project description:BackgroundRehabilitation in hospital is effective in reducing mortality after hip fracture. However, there is uncertainty over optimal in-hospital rehabilitation treatment ingredients, and the generalizability of trial findings to subgroups of patients systematically excluded from previous trials. The aim of this study is to determine the feasibility of a randomized controlled trial which aims to assess the clinical- and cost-effectiveness of adding a stratified care intervention to usual care designed to improve outcomes of acute rehabilitation for all older adults after hip fracture.MethodsThis is a protocol for a single site, feasibility and pilot, pragmatic, parallel group (allocation ratio 1:1) randomised controlled assessor-blind STRATIFY trial (Structured Tailored Rehabilitation AfTer HIp FragilitY Fracture). Adults aged 60 years or more, surgically treated for hip fracture following low energy trauma (fragility fracture), who are willing to provide consent or by consultee declaration (depending on capacity), are eligible. Individuals who experienced in-hospital hip fracture will be excluded. Screening, consent/assent, baseline assessment (demographics, patient reported outcome measures or PROMs [health related quality of life, activities of daily living, pain, falls related self-efficacy], and resource use), and randomization will take place within the first four days post-admission. Participants will then be offered usual care, or usual care plus STRATIFY intervention during their hospital stay. The STRATIFY intervention includes 1) a web-based algorithm to allocate participants to low- medium- or high-risk subgroups; and 2) matched interventions depending on subgroup allocation. The low-risk subgroup will be offered a self-management review, training in advocacy, and a self-managed exercise programme with support for progression, in addition to usual care (1-hour 40 minutes therapist time above usual care). The medium-risk subgroup will be offered education, a goal-orientated mobility programme (with carer training, as available and following carer consent), and early enhanced discharge planning, in addition to usual care (estimated 2-hours 15 minutes therapist time above usual care). The high-risk subgroup will be offered education, enhanced assessment, orientation, and a goal-orientated activities of daily living programme (with carer training, as available and following carer consent), in addition to usual care (estimated 2-hours 45minutes therapist time above usual care). All STRATIFY subgroup treatment interventions are specified using the Rehabilitation Treatment Specification System (RTSS) for treatment theory development and replication. Follow-up PROM data collection, RESOURCE USE alongside readmissions and mortality, will be collected on discharge and 12-weeks post-randomisation. Intervention acceptability will be determined by semi-structured interviews with participants, carers, and therapists at the end of the intervention.DisseminationThe trial findings will be disseminated to patients and the public, health professionals and researchers through publications, presentations and social media channels.Trial registrationThe trial has been registered at clinicaltrials.gov (NCT06014554).

Dataset Information

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.

Publications

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.

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