Rebecca Gossage-Worrall

'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial

BackgroundLoneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention.MethodsParticipants aged >74xa0years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6xa0weeks of short one-to-one telephone calls, followed by 12xa0weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95xa0days; retention of 80% participants at 6xa0months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6xa0months following randomisation.ResultsWe informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95xa0days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16).ConclusionsRecruitment and retention of participants to a definitive trial with a recruitment window of 1xa0year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers.Trial registrationISRCTN28645428.

Only available to a selected few? Is it feasible to rely on a volunteer workforce for complex intervention delivery?

This paper recounts the process of undertaking a randomised controlled trial which was designed to examine the effectiveness of an intervention for socially isolated older people aged 75xa0years and over. It describes the reasons for early cessation of the study and raises the implications of this outcome for policy, practice and research. The intervention under investigation was designed to alleviate loneliness and foster companionship. It involves participants being linked with a small group of others through a teleconferencing system with each group being facilitated by trained volunteers. There was a requirement to recruit and train a minimum of 30 and a maximum of 60 volunteers over 1xa0year to facilitate 20 friendship groups to meet the number of older people required to be recruited to the study. Problems with recruiting and retaining the volunteer workforce by the voluntary sector organisation, who were commissioned to do so, led to the study closing even though older people were recruited in sufficient numbers. The paper draws upon analysis of various data sources from the study to identify the potential reasons. The discussion raises considerations regarding the extent of infrastructure required to deliver community services to vulnerable user groups at scale, identifies some of the issues that need to be addressed if such volunteer-initiated services are to be successful and informs future research programmes in this area.

Adherence with NICE guidance on lifestyle advice for people with schizophrenia: a survey

Aims and method The STEPWISE trial (STructured lifestyle Education for People WIth SchizophrEnia, schizoaffective disorder and first episode psychosis) is currently evaluating a lifestyle education programme in addition to usual care. However, it is difficult to define what constitutes ‘usual care’. We aimed to define ‘usual care’ for lifestyle management in people with schizophrenia, schizoaffective disorder and first-episode psychosis in STEPWISE study sites. Ten National Health Service (NHS) mental health trusts participated in a bespoke survey based on the National Institute for Health and Care Excellence (NICE) guidance. Results Eight trusts reported offering lifestyle education programmes and nine offered smoking cessation support. Reported recording of biomedical measures varied. Clinical implications Although recommended by NICE, lifestyle education programmes are not consistently offered across UK NHS mental health trusts. This highlights missed opportunities to improve the physical health of people with psychotic illness. Our survey benchmarks ‘usual care’ for the STEPWISE study, against which changes can be measured. Furthermore, future studies will be able to identify whether any progress in clinical practice has been made towards achieving the NICE recommendations.

Recruitment of older adults to three preventative lifestyle improvement studies

BackgroundRecruiting isolated older adults to clinical trials is complex, time-consuming and difficult. Previous studies have suggested querying existing databases to identify appropriate potential participants. We aim to compare recruitment techniques (general practitioner (GP) mail-outs, community engagement and clinician referrals) used in three randomised controlled trial (RCT) studies assessing the feasibility or effectiveness of two preventative interventions in isolated older adults (the Lifestyle Matters and Putting Life In Years interventions).MethodsDuring the three studies (the Lifestyle Matters feasibility study, the Lifestyle Matters RCT, the Putting Life In Years RCT) data were collected about how participants were recruited. The number of letters sent by GP surgeries for each study was recorded. In the Lifestyle Matters RCT, we qualitatively interviewed participants and intervention facilitators at 6 months post randomisation to seek their thoughts on the recruitment process.ResultsReferrals were planned to be the main source of recruitment in the Lifestyle Matters feasibility study, but due to a lack of engagement from district nurses, community engagement was the main source of recruitment. District nurse referrals and community engagement were also utilised in the Lifestyle Matters and Putting Life In Years RCTs; both mechanisms yielded few participants. GP mail-outs were the main source of recruitment in both the RCTs, but of those contacted, recruiting yield was low (<u20093%). Facilitators of the Lifestyle Matters intervention questioned whether the most appropriate individuals had been recruited. Participants recommended that direct contact with health professionals would be the most beneficial way to recruit.ConclusionsRecruitment to the Lifestyle Matters RCT did not mirror recruitment to the feasibility study of the same intervention. Direct district nurse referrals were not effective at recruiting participants. The majority of participants were recruited via GP mail-outs, which may have led to isolated individuals not being recruited to the trials. Further research is required into alternative recruitment techniques, including respondent-driven sampling plus mechanisms which will promote health care professionals to recruit vulnerable populations to research.Trial registrationInternational Standard Randomised Controlled Trial Registry, ID: ISRCTN28645428 (Putting Life In Years RCT). Registered on 11 April 2012;International Standard Randomised Controlled Trial Registry, ID: ISRCTN67209155 (Lifestyle Matters RCT). Registered on 22 March 2012;ClinicalTrials.gov, ID: NCT03054311 (Lifestyle Matters feasibility study). Registered retrospectively on 19 January 2017.

Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): Randomised controlled trial

Background Obesity is a major challenge for people with schizophrenia. Aims We assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. Method In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. Results Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI −1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained. Conclusions Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia. Declaration of interest R.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and Kings College London.

Methodological, planning and implementation challenges for rcts evaluating group interventions

Statistical concerns over the design and analysis of RCTs in which patients receive therapy as a group are well documented (see for instance, Roberts C, Clin Trials. 2005;2(2):152-62). By contrast, there is little discussion in the published literature of a range of other challenges to the success of such studies. These include how to plan for and manage: scheduling of participant recruitment, including matching the demand of participants to the supply of interventionists where the RCT evaluates a new service; entry into the study of couples and twins; attrition from the study before and during the course, the threat to protocol compliance and group dynamics; the handling of en-masse protocol violations; the collection of research data by therapists and the delivery of interventions by researchers. Group interventions are heterogeneous and there are a variety of ways in which these issues can be handled. For some, group administration of treatment may be just for convenience and efficiency; for others, the formation and composition of the group may be important for the function of an intervention in which interaction between participants is a key component. n nThis paper collates the experiences of registered CTU study managers and statisticians who have encountered and resolved these questions. Their UKCRCN portfolio studies include medical education, behaviour change and public health interventions delivered, variably, by NHS and University employees as well as third sector volunteers.