Tailored digital behaviour change intervention with e-referral system to increase attendance at NHS stop smoking services (the MyWay project): study protocol for a randomised controlled feasibility trial

Fulton, Emily; Newby, Katie; Gokal, Kajal; Kwah, Kayleigh; Schumacher, Lauren; Jackson, Louise; Naughton, Felix; Coleman, Tim; Brown, Katherine

doi:10.1136/bmjopen-2018-028721

Cited by 6 publications

(6 citation statements)

References 28 publications

(27 reference statements)

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“…Justification for not recording non-serious AEs was given in 6/15 protocols, typically that the intervention was behavioral and not expected to cause harm ( Figs. 3 and 4 ) [15][16][17][18][19][20] .…”

Section: Adverse Events Recordedmentioning

confidence: 99%

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Papaioannou

Cooper

Mooney

et al. 2021

Journal of Clinical Epidemiology

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Section: Adverse Events Recordedmentioning

confidence: 99%

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Papaioannou

Cooper

Mooney

et al. 2021

Journal of Clinical Epidemiology

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“…This is a mixed methods feasibility randomised control trial, with two parallel arms: i) peer supported HOPE4ABI (intervention group); ii) self-directed HOPE4ABI without peer support (control group). The study will be conducted online with UK-based participants, hosted on a secure bespoke online research management platform, eNgage; see (41). Participant information, consent forms, and questionnaires are administered online via Qualtrics Survey Software.…”

Section: Trial Design and Settingmentioning

confidence: 99%

Self-directed versus peer-supported self-management for mental and sexual wellbeing after acquired brain injury: protocol for a feasibility randomised controlled trial

Wright

Walker-Clarke

Drummond

et al. 2023

Preprint

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Background Acquired brain injury (ABI) can lead to biopsychosocial changes such as depression, low self-esteem, and fatigue can cause, and be caused by, sexual issues affecting relationships and wellbeing. Given the relationship between sexual wellbeing and mental health, it is feasible that supporting sexual wellbeing will benefit psychological wellbeing. However, neurorehabilitation is inconsistent and often inadequate across the UK, and psychological, sexual, and social support is lacking. Research shows that self-management and peer-support programmes can improve quality of life, self-efficacy, and psychological wellbeing after brain injury. This protocol describes a feasibility randomised controlled trial (RCT) of a digital self-management programme to support mental and sexual wellbeing (known as HOPE4ABI), co-designed with and for people with ABI. Methods This mixed-methods feasibility RCT has two parallel trial arms of the 8-week digital HOPE4ABI self-management programme. Eligibility criteria includes: age > 18 years, sustained an ABI > 3 months prior to trial entry, access to internet enabled device, and ability to engage with the intervention. Referrals to the study website will be made via National Health Service (NHS), social media, and partnering organisations. Sixty eligible participants will be randomised at a ratio of 1:1 to peer-supported (n = 30) or self-directed (n = 30) HOPE4ABI programme. Primary feasibility outcomes include recruitment and retention rates, engagement, adherence, and usage. Secondary outcomes relate to standardised measures of quality of life, sexual wellbeing, and mental wellbeing. Participants and peer-facilitators will be interviewed after the course to assess acceptability across both trial arms. Discussion This feasibility trial data is not sufficiently powered for inferential statistical analyses but will provide evidence of feasibility of a full RCT. Quantitative trial data will be analysed descriptively, and participant screening data representing age, ethnicity and gender will be presented as proportions at group level. This data may indicate trends in reach to particular demographic groups that may inform future recruitment strategies to widen participation. Progression to a definitive trial will be justified, if predetermined criteria are met, relating to recruitment, retention: engagement, and acceptability. Trial Registration ISRCTN46988394 registered on 1st March 2023.

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“…The study protocol was approved by the NHS West Midlands -Edgbaston Research Ethics Committee (reference 18/WM/0170) and was later published. 36…”

Section: Study Protocol and Interventionmentioning

confidence: 99%

“…This amendment to the protocol was included in the published study protocol. 36 Participants who had already participated were contacted and offered the e-voucher. At the same time as the e-voucher payment was introduced, our monitoring of participant access to the study website via linked analytics software demonstrated that there was a high 'bounce' rate (people clicking the link to the study and then immediately leaving the web page).…”

Section: Challenges With Recruitment and Deviation From Planned Protocolmentioning

confidence: 99%

“…One staff member mentioned combining the existing PharmOutcomes calendar system that is linked to the intervention with a 'PharmAlarm', which indicates to pharmacists when appointments have been made/messages have been received, and is currently under development by Pinnacle Healthcare Ltd (pharmacy32, lines [32][33][34][35][36][37][38]. This feature would be beneficial and would streamline how StopApp communicates with SSS advisors about appointments booked.…”

Section: Adding Technology To the Pharmacy Systemmentioning

confidence: 99%

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A digital behaviour change intervention to increase booking and attendance at Stop Smoking Services: the MyWay feasibility RCT

et al. 2021

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Background Smoking remains a leading cause of illness and preventable death. NHS Stop Smoking Services increase quitting, but, as access is in decline, cost-effective interventions are needed that promote these services. StopApp™ (Coventry University, Coventry, UK) is designed to increase booking and attendance at Stop Smoking Services. Design A two-arm feasibility randomised controlled trial of StopApp (intervention) compared with standard promotion and referral to Stop Smoking Services (control) was conducted to assess recruitment, attrition and health equity of the design, alongside health economic and qualitative process evaluations. Setting Smokers recruited via general practitioners, community settings and social media. Participants Smokers aged ≥ 16 years were recruited in one local authority. Participants had to live or work within the local authority area, and there was a recruitment target of 120 participants. Interventions StopApp to increase booking and attendance at Stop Smoking Services. Main outcome measures Participants completed baseline measures and follow-up at 2 months post randomisation entirely online. Objective data on the use of Stop Smoking Services were collected from participating Stop Smoking Services, and age groups, sex, ethnicity and socioeconomic status in baseline recruits and follow-up completers/non-completers were assessed for equity. Results Eligible participants (n = 123) were recruited over 116 days, with good representation of lower socioeconomic status groups; black, Asian and minority ethnic groups; and all age groups. Demographic profiles of follow-up completers and non-completers were broadly similar. The attrition rate was 51.2%, with loss to follow-up lowest in the social media setting (n = 24/61; 39.3%) and highest in the general practitioner setting (n = 21/26; 80.8%). Most measures had < 5% missing data. Social media represented the most effective and cost-efficient recruitment method. In a future, definitive, multisite trial with recruitment driven by social media, our data suggest that recruiting ≥ 1500 smokers over 12 months is feasible. Service data showed that five bookings for the Stop Smoking Services were scheduled using StopApp, of which two did not attend. Challenges with data access were identified. A further five participants in the intervention arm self-reported booking and accessing Stop Smoking Services outside StopApp compared with two control arm participants. Event rate calculations for the intervention were 8% (Stop Smoking Services data), 17% (including self-reports) and 3.5% from control arm self-reports. A conservative effect size of 6% is estimated for a definitive full trial. A sample size of 840 participants would be required to detect an effect for the primary outcome measure of booking a Stop Smoking Services appointment in a full randomised controlled trial. The process evaluation found that participants were satisfied with the research team contact, study methods and provision of e-vouchers. Staff interviews revealed positive and negative experiences of the trial and suggestions for improvements, including encouraging smokers to take part. Conclusion This feasibility randomised controlled trial found that, with recruitment driven wholly or mainly by social media, it is possible to recruit and retain sufficient smokers to assess the effectiveness and cost-effectiveness of StopApp. The study methods and measures were found to be acceptable and equitable, but accessing Stop Smoking Services data about booking, attendance and quit dates was a challenge. A full trial may be feasible if service data are accessible. This will require careful planning with data controllers and a targeted social media campaign for recruitment. Changes to some study measures are needed to avoid missing data, including implementation of a more intensive follow-up data collection process. Future work We plan a full, definitive randomised controlled trial if the concerns around data access can be resolved, with adaptations to the recruitment and retention strategy. Limitations Our trial had high attrition and problems with collecting Stop Smoking Services data, which resulted in a reliance on self-reporting. Trial registration Research Registry: 3995. The trial was registered on 18 April 2018. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 5. See the NIHR Journals Library website for further project information.

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Tailored digital behaviour change intervention with e-referral system to increase attendance at NHS stop smoking services (the MyWay project): study protocol for a randomised controlled feasibility trial

Cited by 6 publications

References 28 publications

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

Self-directed versus peer-supported self-management for mental and sexual wellbeing after acquired brain injury: protocol for a feasibility randomised controlled trial

A digital behaviour change intervention to increase booking and attendance at Stop Smoking Services: the MyWay feasibility RCT

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