Protocol for the cultural adaptation of pulmonary rehabilitation and subsequent testing in a randomised controlled feasibility trial for adults with chronic obstructive pulmonary disease in Sri Lanka
posted on 2020-12-18, 09:44authored byAkila R Jayamaha, Chamilya H Perera, Mark W Orme, Amy V Jones, Upendra K D C Wijayasiri, Thamara D Amarasekara, Ravini S Karunatillake, Amitha Fernando, Anthony L P Seneviratne, Andy Barton, Rupert Jones, Zainab K Yusuf, Ruhme B Miah, Dominic MalcolmDominic Malcolm, Jesse A Matheson, Robert C. Free, Adrian Manise, Michael C. Steiner, Savithri W Wimalasekera, Sally J. Singh
Introduction International guidelines recommend
pulmonary rehabilitation (PR) should be offered to adults
living with chronic obstructive pulmonary disease (COPD),
but PR availability is limited in Sri Lanka. Culturally
appropriate PR needs to be designed and implemented in
Sri Lanka. The study aims to adapt PR to the Sri Lankan
context and determine the feasibility of conducting a future
trial of the adapted PR in Sri Lanka.
Methods and analysis Eligible participants will be
identified and will be invited to take part in the randomised
controlled feasibility trial, which will be conducted in
Central Chest Clinic, Colombo, Sri Lanka. A total of 50
participants will be recruited (anticipated from April 2021)
to the trial and randomised (1:1) into one of two groups;
control group receiving usual care or the intervention
group receiving adapted PR. The trial intervention is a
Sri Lankan-specific PR programme, which will consist of
12 sessions of exercise and health education, delivered
over 6 weeks. Focus groups with adults living with COPD,
caregivers and nurses and in-depth interviews with
doctors and physiotherapist will be conducted to inform
the Sri Lankan specific PR adaptations. After completion
of PR, routine measures in both groups will be assessed
by a blinded assessor. The primary outcome measure
is feasibility, including assessing eligibility, uptake and
completion. Qualitative evaluation of the trial using focus
groups with participants and in-depth interviews with PR
deliverers will be conducted to further determine feasibility
and acceptability of PR, as well as the ability to run a
larger future trial.
Ethics and dissemination Ethical approval was obtained
from the ethics review committee of Faculty of Medical
Sciences, University of Sri Jayewardenepura, Sri Lanka
and University of Leicester, UK. The results of the trial will
be disseminated through patient and public involvement
events, local and international conference proceedings,
and peer-reviewed journals
Funding
National Institute for Health Research (NIHR) (17/63/20)
This is an Open Access Article. It is published by BMJ under the Creative Commons Attribution 4.0 Unported Licence (CC BY). Full details of this licence are available at: http://creativecommons.org/licenses/by/4.0/