Feasibility study of a sedentary behaviour intervention after stroke
Research type
Research Study
Full title
Feasibility study of an intervention to reduce sedentary behaviour in people after stroke
IRAS ID
261159
Contact name
Anne Forster
Contact email
Sponsor organisation
Bradford Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
This study is the fourth of five workstreams in a National Institute for Health Research funded seven year research programme, which seeks to develop and evaluate strategies for reducing sedentary behaviour after stroke to improve outcomes. We are developing and evaluating a complex intervention to target sedentary behaviour after stroke.\n\nBuilding on the intervention developed through a co-production process in workstream 3, we will undertake a mixed-methods feasibility study in three services, prior to a definitive pragmatic cluster randomised controlled trial. We will explore the feasibility of implementing the intervention using a case study methodology, to clarify procedures for a future trial.\n\nAn implementation group will be created in each of the three services (cases) to regularly review and refine implementation strategies and compliance and fidelity measures. Observations of intervention delivery will be undertaken to gain insight into fidelity of delivery. In addition, interviews will be conducted with stroke survivors and their family members/friends and/or carers to obtain feedback on the acceptability of the intervention, as well as with healthcare professionals to gain their views on any barriers and facilitators to delivering the intervention. Trial procedures will also be clarified and tested including recruitment procedures and outcome assessments. Stroke survivor and family member/friend and/or carer self-completed questionnaires will be collected to assess the usefulness of potential outcome measures and procedures for collecting activity monitor data will also be explored.\n\nAt the end of the study, seminars consisting of staff from the three participating sites and national experts will be held to draw together the lessons and experiences learnt through the feasibility work.
Summary of Results
Introduction The RECREATE feasibility study is the fourth of five workstreams (WS) in a National Institute for Health Research (NIHR) programme, which seeks to develop and evaluate strategies for reducing sedentary behaviour after stroke to improve outcomes. A complex intervention targeting sedentary behaviour after stroke was developed in the earlier workstreams. The intervention comprises of four main components: an education component for staff, stroke survivors and family and friends; guidance on integrating standing and movement into every day staff practice in stroke services; a standing and moving guide (including self-monitoring section) targeted at stroke survivors and with advice for family and friends; an environmental adaptation component.
The aim of the study is to determine the feasibility of conducting a large-scale cluster-randomised controlled trial to investigate the clinical and cost effectiveness of the intervention targeting sedentary behaviour after stroke compared with usual care.
The study objectives were to:
1. Explore the feasibility of delivering each component of the intervention
2. Explore the costs and core resource use
3. Assess acceptability of the intervention
4. Clarify and refine the proposed logic model for the intervention
5. Assess patient eligibility criteria, recruitment processes and data collection
6. Assess measures of fidelity with the intervention and their acceptability
7. Assess the appropriateness of outcome measures assessedMethods
The RECREATE feasibility trial is a prospective, single arm, multi-centre trial. The study aims to recruit three stroke services in which to explore the feasibility of implementing the intervention and trial processes. The trial is non-randomised and includes only a single arm with all recruited stroke services delivering the intervention.
Stroke survivors meeting all of the following inclusion criteria (and none of the exclusion criteria) at screening will be eligible to take part in the study:
1. Aged 16 years or over at time of stroke
2. Have a confirmed primary diagnosis of new stroke and are still in receipt of active rehabilitation in a participating stroke service
3. Able to stand independently or with the help of one person (defined as FAC 3-6)
4. Have been/are being discharged home to live in the community (not a care home)
5. Are able and willing to provide written informed consent or have provided a consultee declaration (England) or welfare attorney, welfare guardian or nearest relative consent (Scotland)Stroke survivors will be excluded if they are:
1. In receipt of end of life care (documented in medical notes)
2. Discharged (or planned discharge) to an address outside the remit of the participating stroke service (including care home)
Self-reported outcome measures will be collected using questionnaires at baseline in the stroke service and by post from the CRTU at follow up (4 and 6 months). Additionally, consenting participants will be asked to wear an activity monitor on their thigh for seven full consecutive days at baseline (ideally on recruitment and in the first week(s) post-discharge), and again at 4 and 6 months post registration. Note that follow-up was only performed at the 4 month time point for the site in Scotland. This was due to increasing complexities of the ethics, HRA and local approval processes.Results
Screening, recruitment and demographics
39 participants were recruited into the study across the 3 sites over a 7-month period (July 2019 to January 2020). 14 participants (36%) had a consenting carer who participated. Participant demographics were similar between those screened and registered, in terms of age, gender and ethnicity. There were some differences in demographics between sites, such as worse cognitive impairment in one site and more co-morbidities in another.Follow-up
Follow-up was completed at 4 and 6 months in English sites and only at 4 months in Scottish sites. Of the 39 registered participants, 22/39 (56%) returned their follow-up questionnaire at 4 months. Of the 25 participants registered in English sites, 10/25 (40%) returned their follow-up questionnaire at 6 months. The primary outcome (NEADL) could be analysed for all participants who returned their questionnaire.
Only 1 participant died during the study (3%). 6 participants withdrew (15%)
3 in Leeds and 3 in Lothian, at 65 to 183 days from registration. No carers died and 1 carer withdrew.
At 4 months, 7 of 14 consenting carers returned the follow-up questionnaire. At 6 months, 3 of 11 consenting carers at English sites returned the follow-up questionnaire (27%).
All questionnaire assessments were sent via post as intended. However, when national lockdown measures were introduced in response to the COVID-19 pandemic in March, prompting return was scaled back (i.e. one reminder was sent rather than two). Lack of prompting / COVID-19 restrictions may have impacted return rate.
Intervention data
Qualitative data was collected across the three sites between June 2019 and January 2020 in order to gain insight into intervention delivery. This included implementation groups (25 hrs) semi-structured interviews with patients and family members/carers (n=12) and staff (n= 28), and observations of inpatient and community settings (99 hrs). Workshops were carried out at the sites to gain final feedback in January 2020.
Outcome measures
Of all registered participants, help with questionnaires needed for 82% at baseline, 20% at 4 months, 4% at 6 months. Help was mostly provided by nurse at baseline and relative at follow-up and included reading of questions, discussing them and ticking boxes.
At baseline, 69% of participants thought it was easy to complete questionnaires and 49% thought there were too many questions. Carers found it easy to complete questionnaires and thought the number of questions was acceptable.
For participant-reported outcome measures, the WEMWBS, NEADL and FAS were fully completed for almost all participants who returned their questionnaires. WHODAS was partially completed for 28% at baseline and 21% at follow-up (% out of registered). MOST was partially completed for 10% at baseline, 26% at 4 months and 16% at 6 months (% out of registered). Where questionnaires were partially completed, pro-rating was rarely possible, except for the WHODAS questionnaire.
At baseline, an activPAL monitor was administered to 38/39 (97.4%) participants. Of those administered, 34 (89.5%) monitors were returned and data from 27 participants (71% of those administered) passed the initial quality assurance process. Reasons for not passing the quality assurance check were: incorrect monitor set-up (n = 1); incorrect positioning of the monitor (n = 4) and non-wear (n = 2). Notably, all instances of incorrect positioning of the monitor were from the same site. This highlighted the need to ensure research staff undertaking recruitment and administering the monitors in the definitive trial are provided with on-going support, particularly at the beginning of the trial, to supplement the training delivered. Standard operating procedures for use of the actviPAL monitor and training resources have also been refined.
In line with government guidance, patient visits to administer the activPAL activity monitor were suspended from the 23rd March 2020. This did mean that five (13% of those registered) and 15 (60% of those available) participants were not approached to wear an activPAL at the 4-month and 6-month time-points respectively. Although limited data was collected at follow-up, the team have been proactive in exploring methods of maximising participant compliance and refining data collection procedures which are to be implemented in the definitive trial.
Implications for the main trial
Screening processes were amended to make it simpler and less time-consuming for sites to complete. Intervention forms were amended to encourage completion. We will monitor screening forms and intervention forms received during the main trial to ensure these are completed.
To improve the follow-up rates, we will include more resources, including priming messages before questionnaires are sent and reminders after questionnaires are sent by SMS or email.
The questionnaire pack has also been shortened to improve completion and return rates. Mechanisms of change questionnaires have been removed and the WHODAS questionnaire has been replaced with the brief WHODAS 2.0 version. To encourage the return of the activPAL device, the wording of the activPAL information sheets have been amended.
We worked to refine the intervention using the tables of change approach which is based on the person based approach by Yardley et al. (2015). This involved populating tables with qualitative data from interviews (patients and staff) observations, and implementation groups and outlining suggested changes to both the content and implementation approach.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0080
Date of REC Opinion
8 May 2019
REC opinion
Further Information Favourable Opinion