Evidence map›Paper›PMID 38325873›Full record

Trial reportBMJ (Clinical research ed.)2024

Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial.

Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Sharisse Alleyne, Jessica Smith and 12 more

Erratum issuedOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 64 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 6 pooled it
28.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 6 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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  16. Personalised Health Behaviour Support Programme in Adults With Post-COVID Syndrome: A Randomised, Controlled Pilot Feasibility Trial.Health expectations : an international journal of public participation in health care and health policy · 2024
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 5 institutions in 2 countries.

Gordon McGregorUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.ORCID 0000-0001-8963-9107
Harbinder SandhuWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Julie BruceUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Bartholomew SheehanOxford Psychological Medicine Centre, John Radcliffe Hospital, Oxford, UK.
David McWilliamsCentre for Care Excellence, University Hospitals Coventry and Warwickshire NHS Trust and Coventry University, Coventry, UK.
Joyce YeungWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Christina JonesICUsteps, Kemp House, London, UK.
Beatriz LaraUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Sharisse AlleyneWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Jessica SmithWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Ranjit LallWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Chen JiWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Mariam RatnaWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Stuart EnnisUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Peter HeineWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Shilpa PatelUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Charles AbrahamSchool of Psychology, Deakin University, Geelong, Australia.
James MasonWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Henry NwankwoWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Vivien NicholsWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Kate SeersWarwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, UK.
Martin UnderwoodUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
University of Warwick · GBUniversity Hospitals Coventry and Warwickshire NHS Trust · GBDeakin University · AUJohn Radcliffe Hospital · GBUniversity Hospitals Birmingham NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate whether a structured online supervised group physical and mental health rehabilitation programme can improve health related quality of life compared with usual care in adults with post-covid-19 condition (long covid).

designPragmatic, multicentre, parallel group, superiority randomised controlled trial.

settingEngland and Wales, with home based interventions delivered remotely online from a single trial hub.

participants585 adults (26-86 years) discharged from NHS hospitals at least three months previously after covid-19 and with ongoing physical and/or mental health sequelae (post-covid-19 condition), randomised (1:1.03) to receive the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) intervention (n=298) or usual care (n=287).

interventionsBest practice usual care was a single online session of advice and support with a trained practitioner. The REGAIN intervention was delivered online over eight weeks and consisted of weekly home based, live, supervised, group exercise and psychological support sessions.

main outcome measuresThe primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months. Secondary outcomes, measured at three, six, and 12 months, included PROMIS subscores (depression, fatigue, sleep disturbance, pain interference, physical function, social roles/activities, and cognitive function), severity of post-traumatic stress disorder, general health, and adverse events.

resultsBetween January 2021 and July 2022, 39 697 people were invited to take part in the study and 725 were contacted and eligible. 585 participants were randomised. Mean age was 56 (standard deviation (SD) 12) years, 52% were female participants, mean health related quality of life PROMIS-PROPr score was 0.20 (SD 0.17), and mean time from hospital discharge was 323 (SD 144) days. Compared with usual care, the REGAIN intervention led to improvements in health related quality of life (adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02) at three months, driven predominantly by greater improvements in the PROMIS subscores for depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P<0.001), and pain interference (1.80 (0.50 to 3.11), P=0.01). Effects were sustained at 12 months (0.03 (0.01 to 0.06), P=0.02). Of 21 serious adverse events, only one was possibly related to the REGAIN intervention. In the intervention group, 141 (47%) participants fully adhered to the programme, 117 (39%) partially adhered, and 40 (13%) did not receive the intervention.

conclusionsIn adults with post-covid-19 condition, an online, home based, supervised, group physical and mental health rehabilitation programme was clinically effective at improving health related quality of life at three and 12 months compared with usual care.

trial registrationISRCTN registry ISRCTN11466448.

Indexed as

COVID-19Psychiatric RehabilitationAdultCost-Benefit AnalysisFemaleHumansMaleMiddle AgedPainPost-Acute COVID-19 SyndromeQuality of LifeTreatment Outcome

Identifiers

PMID38325873
PMCPMC11134408
OpenAlexW4391775658

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.