Improving life quality in chronic obstructive pulmonary disease (COPD) by increasing uptake and completion of pulmonary rehabilitation with lay health workers: a cluster randomised controlled trial

King's College London0 sites1,577 target enrollmentJanuary 23, 2023

ConditionsChronic obstructive pulmonary disease Respiratory

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic obstructive pulmonary disease
Sponsor: King's College London
Enrollment: 1577
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38500191/ (added 22/03/2024)

Registry

who.int

Start Date

January 23, 2023

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

King's College London

Eligibility Criteria

Inclusion Criteria

•Category A \- Inclusion criteria of participating pulmonary rehabilitation sites:
•1\. \> 200 pulmonary rehabilitation referrals per year to allow for at least 35 (17\.5%) participants to be recruited over six months.
•2\. Conduct routine baseline and final pulmonary rehabilitation session data including uptake and completion rates, quality of life assessment (COPD Assessment Test\-CAT or Chronic Respiratory Questionnaire \-CRQ\-SAS), exercise tests (Six Minute Walking Distance \- 6MWD or Intermittent Shuttle Walk Test \- ISWT), and well\-being assessment (General Anxiety Disorder Assessment 7 – GAD7\) and (Patient Health Questionnaire 9 \-PHQ9 or Hospital Anxiety and Depression Scale HADS).
•3\. Completion rate \< \= 55% determined by count based on appropriate referrals received. Referrals of non\-COPD chest problems and patients with significant other disabilities that prevent participation should not be included in the completion rate denominator. The decision to limit inclusion to sites with a completion rate of 55% or less relates to the priority given to service inequalities and the need for the NHS to have a threshold for the introduction of the intervention. Including all sites may diminish the opportunity to show a difference in those services in greatest need.
•4\. Agree to randomisation to intervention or usual care
•5\. Agree to include all eligible patients in the invitation to be randomised for the PRB intervention or usual care.
•6\. Agree to release three pulmonary rehabilitation staff for training (not simultaneously) over 2 days with an additional half\-day remote training
•7\. Agree that two pulmonary rehabilitation staff will undertake intervention delivery
•8\. Agree on the third pulmonary rehabilitation staff member to have a backup role in event of a colleague becoming ill or leaving the service during recruitment and LHW training.
•9\. At least two of three participating staff members to be a registered healthcare professional (HCP)

Exclusion Criteria

•Category A \- Exclusion criteria of participating pulmonary rehabilitation sites:
•1\. Unable to join trial until after June 2023
•2\. Unable to identify at least three members of staff for the trial willing to consent to participation
•3\. Local trust R\&D office unwilling to support the trial
•Category B \- Exclusion criteria of pulmonary rehabilitation site participating staff:
•1\. Will not be employed in their post for the duration of the trial at the site in question
•Category C \- Exclusion criteria of pulmonary rehabilitation buddy volunteers
•1\. Unable to participate for the duration of the trial at the site in question
•2\. Unable to travel independently to meet referred patients
•3\. Unable or unwilling to use a smart mobile phone