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, Ranjit Lall, Chen Ji, Mariam Ratna, Stuart Ennis, Peter Heine, Shilpa Patel, Charles Abraham, James Mason, Henry Nwankwo, Vivien NicholsKate Seers, Martin Underwood, Martin Underwood

Research output: Contribution to journalArticlepeer-review

7 Downloads (Pure)

Abstract

OBJECTIVE: To 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).

DESIGN: Pragmatic, multicentre, parallel group, superiority randomised controlled trial.

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

PARTICIPANTS: 585 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).

INTERVENTIONS: Best 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 MEASURES: The 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.

RESULTS: Between 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.

CONCLUSIONS: In 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 REGISTRATION: ISRCTN registry ISRCTN11466448.

Original languageEnglish
Article numbere076506
Number of pages13
JournalBMJ (Clinical research ed.)
Volume384
Early online date7 Feb 2024
DOIs
Publication statusPublished - 7 Feb 2024

Bibliographical note

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.

Funder

This trial was funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme. All researchers can confirm their independence from funders, and all authors, external and internal, had full access to all the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

Keywords

  • Adult
  • COVID-19
  • Cost-Benefit Analysis
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pain
  • Post-Acute COVID-19 Syndrome
  • Psychiatric Rehabilitation
  • Quality of Life
  • Treatment Outcome

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this