Lifestyle matters randomized controlled trial of a preventive health intervention for older people: Qualitative sub study with participants and intervention facilitators

© 2020 Mountain et al. Objective: This qualitative study embedded within a randomized controlled trial was conducted to explore the acceptability, experiences of, and short-term impact of a preventive health intervention (Lifestyle Matters) from the perspectives of those who took part, and to uncover any evidence for the theorised mechanisms of action (improved participation and self efficacy) underpinning the intervention. It was also conducted to help explain the quantitative trial results. Methods: A purposive sample of 13 trial participants who had been randomized to receive the Lifestyle Matters intervention (approximately 10%) were individually qualitatively interviewed immediately following their involvement. All four intervention facilitators were also individually interviewed. Results: Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention. However, lack of adherence to the overall intervention eroded receipt of benefit. This finding complements the quantitative trial results which found that the study had failed to recruit those who considered themselves to be at risk of age-related decline. Conclusion: This form of preventive health intervention requires proactive identification of those who recognise the need to make lifestyle changes. This is difficult if reactive health and social care systems are the main referral routes. The methodological approaches taken towards the study of complex interventions requires reconsideration if potential benefits are to be accurately assessed. Clinical Trial Registration: ISRCTN67209155

Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials

© 2020 The Author(s). Background: Poor recruitment in clinical trials is well-documented. In large, multi-centre trials, communication between the coordinating centre and trial sites is essential. A commonly used communication tool is the hosting of an investigator/collaborator meeting, which offers an opportunity for sites to re-train and receive trial updates, learn from each other, share best practice and troubleshoot issues. Anecdotally, there is a perception that recruitment rates may increase after holding such a meeting. The aim of this before-and-after study was to examine any changes in recruitment after an investigator meeting. Methods: We conducted a retrospective study of nine trials at the Nottingham Clinical Trials Unit (NCTU) that were open to recruitment between 2014 and 2018. In the 8 weeks prior to the date of the investigator meeting, 82 sites (across nine trials) were open to recruitment; 60 of which attended the meeting, 22 who did not. Using meeting attendance data available in Trial Master Files (TMF) and recruitment data from randomisation datasets, we examined recruitment rates in the 8 weeks prior to and following the date of the investigator meeting. Results: For the 82 sites included, 284 participants were recruited in the 8 weeks prior to the meeting, with a further 300 participants recruited in the 8 weeks post meeting. This gives a mean change in weekly recruitment of 0.073 (- 0.129, 0.275) per site, demonstrating no statistically significant increase in recruitment after the investigator meeting. For the 60 attending sites, recruitment increased from 254 participants prior to the meeting to 271 post meeting, giving a 0.100 (- 0.160, 0.360) mean change in weekly recruitment per site, providing no evidence that recruitment rates increase following an investigator meeting. Conclusion: There is no statistical evidence to conclude that holding an investigator meeting increases recruitment in the 8 weeks following the meeting. Thus, if the meeting has been held in the belief that it will have a positive impact upon recruitment, trialists may wish to consider other evidence-based strategies known to increase recruitment rates. However, since there are a variety of reasons why an investigator meeting may be held, trialists should continue to consider this as a communication strategy with sites

Value and engagement : what can clinical trials learn from techniques used in not-for-profit marketing?

No funding has been received for this work.Peer reviewedPublisher PD

The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study

Objectives To assess the long-term effect on health and well-being of the Lifestyle Matters programme. Design Qualitative study of a subset of intervention arm participants who participated in the Lifestyle Matters randomised controlled trial (RCT). Setting The intervention took place at community venues within two sites in the UK. Participants A purposeful sample of 13 participants aged between 66 and 88 years from the intervention arm of the RCT were interviewed at 24 months post randomisation. Interviews aimed to understand how participants had used their time in the preceding 2 years and whether the intervention had any impact on their lifestyle choices, participation in meaningful activities and well-being. Intervention Lifestyle Matters is a 4-month occupational therapy intervention, consisting of group and individual sessions, designed to enable community living older people to make positive lifestyle choices and participate in new or neglected activities through increasing self-efficacy. Results Interviews revealed that the majority of interviewed participants were reportedly active at 24 months, with daily routines and lifestyles not changing significantly over time. All participants raised some form of benefit from attending Lifestyle Matters, including an improved perspective on life, trying new hobbies and meeting new friends. A number of intervention participants spoke of adapting to their changing circumstances, but there were significant and lasting benefits for 2 of 13 intervention participants interviewed. Conclusion The majority of those who experienced the Lifestyle Matters intervention reported minor benefits and increases in self-efficacy, but they did not perceive that it significantly improved their health and well-being. The two participants who had experienced major benefits also reported having had life-changing events, suggesting that this intervention is most effective at the time when lifestyle has to be reconsidered if mental well-being is to be sustaine

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial

Objectives: Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions. Design: We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention. Intervention: The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions. Results: The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics. Conclusions: The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions. Trial registration number: ISRCTN67209155

Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over : a feasibility study to inform a future trial

Background: A study to determine the feasibility of conducting a future population-based trial into a self-management intervention for community-living adults with early stage dementia included evaluation of intervention content and modes of delivery, staffing requirements, recruitment methods and the utility and usability of patient reported outcomes. Methods: Participants identified through memory clinics in one city took part in an intervention called ‘Journeying through Dementia’. The 12-week programme incorporating four individual sessions with one of the facilitators encourages participants to engage in discussion and activities related to health and well-being positioning them as the expert enabling long-term behavioural change. Participants (n = 10) and their nominated carers (n = 7) were all asked to complete selected outcomes at baseline, 8 weeks (participants only) and post intervention and invited to comment on their usability. All participants and carers were qualitatively interviewed before intervention delivery about their expectations and participants; nominated carers and facilitators were all interviewed after cessation about their experiences. Results: The manualised intervention and modes of delivery proved acceptable to participants and carers. Reported benefits included increased confidence and self-efficacy, engagement in new or lapsed activities and re-engagement in fun and friendships. People with dementia and carers were able to self-complete all outcome measures, but time required to complete the measures is a key factor. Strategies for recruitment need to include direct contact within 24–48 h post invitation to the study. Analysis of data on the primary outcome did not reveal any trends. Facilitators found the training and support to be appropriate and helpful. Conclusions: The tailored intervention reportedly met the needs of all participants. The study confirmed the need for careful identification and application of patient-reported outcome measures. Outcomes to measure some dimensions of reported benefit are not available

Promoting Independence in Dementia (PRIDE): A Feasibility Randomized Controlled Trial

Background: There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living well and enhance independence for people with mild dementia.Methods: In this two arm parallel group, feasibility RCT at six sites in England, participants were randomized (1:1) to the PRIDE intervention (encompassing social, physical, and cognitive domains supported by a facilitator over three sessions) compared to usual care only. The main objective was to determine the feasibility of a main trial with respect to measures of recruitment, retention, and adherence to the intervention.Results: During a 7-month period, 402 people were invited to the trial, 148 were screened (37%, 95% confidence interval (CI)=32– 42%), 137 were eligible at pre-consent, 94 consented to the trial (69% of those eligible, 95% CI=60– 76%), and 92 were randomized (46 to each group). Of those allocated to the intervention, 42 (91%) received at least one of three intervention sessions. Outcome assessment follow-up visits were completed for 73 participants at 6 months (79%, 95% CI=70– 87%), and this was similar for both groups.Conclusion: A large multi-center trial of the PRIDE intervention in community-dwelling people with mild dementia is feasible using systematic recruitment strategies. The intervention was successfully delivered and well received by participants. Findings from this study will be used to refine the design and processes for a definitive RCT.Trial Registration: ISRCTN, ISRCTN11288961, registered on 23 October 2018

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?

Marketing is a core business function in commercial companies but is also frequently used by not-for-profit organisations. Marketing focuses on understanding what people value to make choices about engaging with a product or service: a concept also key to understanding why people may choose to engage with a clinical trial. Understanding the needs and values of stakeholders, whether they are participants, staff at recruiting sites or policy-makers, is critical for a clinical trial to be a success. As many trials fail to recruit and retain participants, perhaps it’s time for us to consider approaches from other disciplines? Though clinical trial teams may consider evidence- and non-evidence-based recruitment and retention strategies, this is rarely done in a systematic, streamlined way and is often in response to challenges once the trial has started. In this short commentary, we argue the need for a formal marketing approach to be applied to clinical trials, from the outset, as a potential prevention to recruitment and retention problems

Recruitment of older adults to three preventative lifestyle improvement studies

YesBackground: Recruiting 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). Methods: During 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. Results: Referrals 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 (< 3%). 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. Conclusions: Recruitment 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.The Lifestyle Matters RCT was funded by the Medical Research Council (grant number G1001406); Sheffield Health and Social Research Consortium; National Institute for Health Research Public Health Research programme (project number 09/ 3004/01