Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE).

INTRODUCTION: Stroke survivors spend long periods of time engaging in sedentary behaviour (SB) even when their functional recovery is good. In the RECREATE programme, an intervention aimed at reducing SB ('Get Set Go') will be implemented and evaluated in a pragmatic external pilot cluster randomised controlled trial with embedded process and economic evaluations. We report the protocol for the process evaluation which will address the following objectives: (1) describe and clarify causal assumptions about the intervention, and its mechanisms of impact; (2) assess implementation fidelity; (3) explore views, perceptions and acceptability of the intervention to staff, stroke survivors and their carers; (4) establish the contextual factors that influence implementation, intervention mechanisms and outcomes. METHODS AND ANALYSIS: This pilot trial will be conducted in 15 UK-based National Health Service stroke services. This process evaluation study, underpinned by the Medical Research Council guidance, will be undertaken in six of the randomised services (four intervention, two control). Data collection includes the following: observations of staff training sessions, non-participant observations in inpatient and community settings, semi-structured interviews with staff, patients and carers, and documentary analysis of key intervention components. Additional quantitative implementation data will be collected in all sites. Training observations and documentary analysis data will be summarised, with other observational and interview data analysed using thematic analysis. Relevant theories will be used to interpret the findings, including the theoretical domains framework, normalisation process theory and the theoretical framework of acceptability. Anticipated outputs include the following: recommendations for intervention refinements (both content and implementation); a revised implementation plan and a refined logic model. ETHICS AND DISSEMINATION: The study was approved by Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (REC reference: 19/YH/0403). Findings will be disseminated via peer review publications, and national and international conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN82280581.

Developing the evidence and associated service models to support older adults living with frailty to manage their pain and to reduce its impact on their lives: protocol for a mixed-method, co-design study (The POPPY Study).

INTRODUCTION: The Pain in Older People with Frailty Study is a mixed-method, co-design study, which aims to develop the content, implementation strategies, service and professional guidance to support older adults with frailty to manage their pain. METHODS AND ANALYSIS: The study has four phases: Phase 1, research evidence and information synthesis from randomised controlled trials of multicomponent pain management programmes and psychological therapies for community-dwelling older adults. Phase 2, qualitative interviews with 30 community-dwelling older adults (≥75 years) living with frailty and persistent pain, including dyadic interviews with a spouse or unpaid carer. Phase 3, qualitative interviews with healthcare professionals (HCPs) working within various pain service types; 5-8 HCPs per service and up to 12 services including primary care, secondary care, tertiary centres and services with voluntary sector input. Phase 4, co-design workshops with older adults, HCPs and commissioners. Inclusion criteria (Phase 2): community-dwelling older adults (≥75 years) living with frailty and persistent pain. Exclusion criteria (Phase 2): care home residents, a dementia or cancer diagnosis. Cancer survivors, ≥5 years cancer free, and not undergoing active cancer treatment can participate. Analysis for Phase 1 will use narrative synthesis, Phase 2 will use grounded theory analysis and Phase 3 will use thematic analysis. Oversight is provided from a patient and public involvement group and an independent steering committee. ETHICS AND DISSEMINATION: The protocol was approved by Leeds-East Research Ethics Committee on 28 April 2022 (22/YH/0080). Consent is sought if an individual is willing to participate (Phases 2-4) and has capacity. Findings will be disseminated at conferences, in newsletters and journals and to local authorities and charities.

Therapeutic landscape experiences of everyday geographies within the wider community: A scoping review.

As community dwelling populations of older people and those living with chronic and life limiting conditions continue to grow, the role of everyday geographies, particularly of community based settings and activities, in supporting health and wellbeing has become a focus in both research and policy development. The therapeutic landscape scholarship provides a holistic view of how place promotes health and wellbeing, and has in recent years expanded its focus from reputable places of healing to everyday geographies. Based on a scoping review of 45 studies on everyday community based therapeutic landscapes, this paper identifies and critically examines the settings, populations and mechanisms of therapeutic experiences. It presents critical summaries of the scales and boundaries of landscapes; the diverse and dichotomous characteristics of places; the therapeutic benefits of proximal and distal socio-spatial interactions; the role of everyday settings and activities as sources of refuge, anchor and resonance and finally the broader social, cultural, political and economic contexts in which everyday therapeutic landscapes are embedded. In so doing the paper highlights the complex nature of everyday therapeutic landscape experiences and how this research can further inform the development of community based settings and activities that promote health and wellbeing. It also identifies areas for future research on everyday therapeutic landscapes.

Life in lockdown: a telephone survey to investigate the impact of COVID-19 lockdown measures on the lives of older people (≥75 years).

BACKGROUND: In response to the coronavirus disease 2019 (COVID-19) pandemic, the UK government introduced social distancing measures and identified specific populations at high risk from the virus. People ≥70 were deemed 'Clinically Vulnerable'. Distancing measures were introduced to reduce the risk of contracting COVID-19. However, these may have a negative impact on older people who are vulnerable to social isolation and may have challenges accessing services and provisions. OBJECTIVES: To investigate the impact of COVID-19 lockdown measures on the lives of older people. STUDY DESIGN AND SETTING: Cross-sectional telephone survey. PARTICIPANTS: Community-dwelling older people, 76-97 years. OUTCOMES: Health anxiety; General health (RAND Short-form 36 Survey); Physical activity; Depression (PHQ-8); Anxiety (GAD-2); Loneliness; Access to services; Challenges, concerns and positive experiences. DATA ANALYSIS: Counts (%), means (SDs). Thematic analysis was used to identify themes from open questions. RESULTS: n = 142. 52% did not worry about their health; 76% rated their health as 'good', 'very good' or 'excellent'; <10% met the criteria indicative of depression (PHQ-8), or anxiety (GAD-2); 42% were less active than before lockdown; and 27% were lonely at least some of the time. Over half of participants identified positive aspects. CONCLUSIONS: Most participants reported good health with low levels of health anxiety, anxiety and depression. Many were able to identify positive aspects to lockdown and may be better equipped to deal with lockdown than anticipated. Strategies may be required to ameliorate the negative impact of loneliness for a minority of older people, and help some resume previous activity levels and pursuits.

Group psychological intervention for postnatal depression: a nested qualitative study with British South Asian women.

BACKGROUND: Postnatal depression affects 10-15 % of all mothers in Western societies and remains a major public health concern for women from diverse cultures. British Pakistani and Indian women have a higher prevalence of depression in comparison to their white counterparts. Research has shown that culturally adapted interventions using Cognitive Behavioural Therapy (CBT) may be acceptable and may help to address the needs of this population. The aim of this study was to assess the acceptability and overall experience of the Positive Health Programme by British South Asian mothers. METHODS: This was a nested qualitative study, part of an exploratory randomized controlled trial (RCT) conducted to test the feasibility and acceptability of a culturally-adapted intervention (Positive Health Programme or PHP) for postnatal depression in British South Asian women. In-depth interviews (N = 17) were conducted to determine the views of the participants on the feasibility and acceptability of the intervention. RESULTS: The participants found the intervention acceptable and experienced an overall positive change in their attitudes, behaviour, and increased self-confidence. CONCLUSIONS: The findings suggest that the culturally adapted Positive Health Programme is acceptable to British South Asian women. These results support that culturally sensitive interventions may lead to better health outcomes and overall satisfaction. TRIAL REGISTRATION: Protocol registered on Clinicaltrials.gov NCT01838889.

A scoping review to understand the effectiveness of linking schemes from healthcare providers to community resources to improve the health and well-being of people with long-term conditions.

The prevalence of people living with long-term conditions is increasing, accompanied by an increased expectation that patients will become more involved in self-management. Long-term conditions are associated with increased social isolation and poor physical and mental health. But there remains a gap in health provision between providing medical treatment and effectively addressing psychosocial well-being. One potential way of addressing this gap is by utilising social interventions which link patients from health services to community-based sources of support. However, the mechanisms involved in the delivery of interventions providing that link and their effectiveness remain unclear. This review adopted the methodological framework for conducting scoping studies, searching for both academic and grey literature on social interventions which link people from healthcare settings to a range of community and voluntary sector organisations. A literature search between May and June 2013, involving five electronic databases, hand searching of two journals and the use of Google search engine, identified seven studies relevant to the review question. In terms of key characteristics and mechanisms of the interventions, mental health conditions and social isolation were the most common reasons for referral to the interventions, and referrals were usually made through general practices. Almost all the interventions were facilitator-led, whereby the facilitator worked to identify and link participants to appropriate community-based resources. In regard to health and social outcomes and their cost-effectiveness, studies reported improvement to participants' psychological and social well-being as well as their decreased use of health services, although there were limited measures of participants' physical health outcomes. Interventions for linking patients from healthcare setting to community-based resources target and address psychosocial needs of participants. The review identified involvement of health professionals in aiding the referral of patients to the intervention and the role of the intervention facilitators as key components of the interventions.

Predictors of patient self-report of chronic kidney disease: baseline analysis of a randomised controlled trial.

BACKGROUND: Improving the quality of care for patients with vascular disease is a priority. Clinical guidance has emphasised the importance of early identification and active management of chronic kidney disease (CKD) in primary care in order to maintain vascular health. However, awareness of stage 3 CKD amongst patients remains limited. We aimed to identify predictors of patient self-report of CKD to inform tailoring of conversations around CKD in primary care for diverse patient populations. METHODS: We conducted a cross-sectional analysis of baseline data from 436 patients with stage 3 CKD from 24 GP practices taking part in a randomised controlled trial (RCT) evaluating a complex self-management intervention, which aimed to support the maintenance of vascular health in patients with stage 3 CKD. Potential predictors of patient self-report of CKD included demographics, stage of CKD, cardiovascular risk, self-reported co-morbidities, health status, self-management ability, and health service utilisation. RESULTS: Around half (52%, n = 227) of patients did not self-report CKD. Self-report rates did not appreciably differ by practice. Multivariate analysis revealed that female patients (p = 0.004), and patients with stage 3b CKD (p < 0.001), and with higher anxiety levels (p < 0.001), were more likely to self-report CKD. CONCLUSIONS: Self-report of kidney problems by patients on CKD registers was variable and patterned by sociodemographic factors. Although it cannot be assumed that failure to self-report indicates a lack of awareness of CKD, our data do suggest the need for greater consistency in discussions around kidney health, with meaningful and relevant clinical dialogue that is aligned with existing clinical encounters to enable shared decision making and minimise anxiety.

Effect of information and telephone-guided access to community support for people with chronic kidney disease: randomised controlled trial.

BACKGROUND: Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. METHODS AND FINDINGS: In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. CONCLUSIONS: An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN45433299.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial.

BACKGROUND: Improving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease. METHODS/DESIGN: The study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial. DISCUSSION: The management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage. TRIAL REGISTRATION: Trial registration reference: ISRCTN45433299.