In-person and online mixed method non-randomised studies exploring feasibility and acceptability of HEADS: UP, an adapted Mindfulness-Based Stress Reduction programme for stroke survivors experiencing symptoms of anxiety and depression.

BACKGROUND: Depression and anxiety are prevalent after stroke and associated with poor outcomes. We previously co-developed a stroke-specific self-management intervention, HEADS: UP (Helping Ease Anxiety and Depression after Stroke). The two studies reported here aimed to test the feasibility and acceptability of the HEADS: UP course and supporting materials, and research processes ahead of a definitive trial. METHODS: We recruited community-dwelling stroke survivors (SS) ≥ 3 months post-stroke, with symptoms of mood disorder (Hospital Anxiety and Depression Scale ≥ 8). Participants could 'enrol' a family member/ 'other' to take part with them, if desired. Study 1 tested HEADS: UP delivered in-person, and informed optimisation of research processes and intervention delivery and materials. In a pragmatic response to Covid-related socialising restrictions, HEADS: UP was then adapted for online delivery, tested in Study 2. The primary outcome (both studies) was the feasibility (acceptability, fidelity) of the intervention and of research processes. Quantitative data (including patient-reported outcome measures (PROMs) assessing mood and quality of life) and qualitative data were collected pre-/post-intervention. Descriptive statistics were used to analyse quantitative data; a thematic framework approach was used to analyse qualitative data. Both studies received ethical approval prior to commencement. RESULTS: Study 1 Feasibility: 13 (59.1%) of 22 potentially eligible stroke survivors consented; aged 66 (median, interquartile range (IQR) 14); male (n = 9; 69%); 28 (IQR 34) months post-stroke. Of these, n = 10 (76.9%) completed PROMS pre-intervention; n = 6 (46.2%) post-intervention. Acceptability: Nine (69.2%) of the 13 participants attended ≥ 4 core intervention sessions. Aspects of screening and data collection were found to be burdensome. Study 2 Feasibility: SS n = 9 (41%) of 22 potentially eligible stroke survivors consented; aged 58 years (median; IQR 12); male (n = 4; 44.4%); 23 (IQR 34) months post-stroke. Of these, n = 5 (55.6%) completed PROMS pre-intervention; n = 5 (55.6%) post-intervention. Acceptability: Five (55.6%) of the 9 participants attended ≥ 4 core sessions. They found online screening and data collection processes straightforward.

Women's Experiences of Urinary Tract Infections and Impact on Life: An Exploratory Qualitative Study.

IMPORTANCE: Despite high incidences of urinary tract infections (UTIs), little is known about how bothersome symptoms are and the effects on women's life and sexual activity, leaving a gap in our understanding of the physical and emotional effects of UTIs on women. OBJECTIVES: This initial exploratory and descriptive study analyzes women's experiences of UTI and their perceived impact on quality of life. STUDY DESIGN: Qualitative interviews were undertaken with 23 women who had experienced at least 1 UTI, recruited from different settings-primary care, general gynecology clinics, urogynecology clinics, and online via social media. Data were analyzed thematically. RESULTS: Three themes described women's experiences of UTI: Women in all groups reported a wide range of physical symptoms and described the financial and psychological effects of UTIs. These effects seemed worse in women recruited via social media who also reported experiencing strong emotions and worries about close family members. Urinary tract infection support groups were considered useful, with women being grateful for consultations with alternative health practitioners and presuming safety of natural products. CONCLUSIONS: Having a UTI appeared to affect women in a variety of ways, ranging from having different physical symptoms to being psychologically affected by these symptoms, which affected their quality of life in different ways. This research contributes to the growing evidence on how UTIs affect women, specifically further expanding on the impact on women in a range of settings-in the community and different health care settings.

The HEADS: UP Development Study: Working with Key Stakeholders to Adapt a Mindfulness-Based Stress Reduction Course for People with Anxiety and Depression after Stroke.

BACKGROUND: Following stroke, rates of mood disorder are and remain high at five years (anxiety 34.4%; depression 23%). Structured mindfulness-based stress reduction (MBSR) courses are effective in a range of health conditions, but stroke survivors find adherence challenging. We aimed to adapt a standard MBSR course specifically for people affected by stroke. METHODS: We recruited stroke survivors and family members with symptoms of anxiety and/or depression to take part in a co-development study comprising two rounds of MBSR 'taster' sessions, followed by focus groups in which views were sought on the practices sampled. Data were collected in October 2017 and May 2018 and were analysed using framework analysis, informed adaptations to mindfulness materials and delivery. RESULTS: Twenty-eight stroke survivors and seven family members participated. Nineteen (76%) stroke survivors had anxiety; 15 (60%) had depression. Five (71.4%) family members reported anxiety; n = 4 (57.1%) depression. Thirty participants attended the first round of taster sessions and focus groups; twenty (66%) the second and three (10%) were unable to attend either round. Framework analysis informed adaptations to course delivery, practices, and materials, ultimately resulting in a stroke-specific MBSR course, HEADS: UP (Helping Ease Anxiety and Depression after Stroke). CONCLUSIONS: HEADS: UP may provide a feasible, appropriate, and meaningful self-management intervention to help alleviate symptoms of mood disorder.

A systematic review and meta-analysis exploring the efficacy of mindfulness-based interventions on quality of life in people with multiple sclerosis.

BACKGROUND: Quality of life (QoL) is commonly impaired among people with multiple sclerosis (PwMS). The aim of this study was to evaluate via meta-analysis the efficacy of Mindfulness-based interventions (MBIs) for improving QoL in PwMS. METHODS: Eligible randomized controlled trials (RCTs) were identified via searching six major electronic databases (MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, AMED, and PsycINFO) in April 2022. The primary outcome was QoL. Study quality was determined using the Cochrane Collaboration risk of bias tool. Meta-analysis using a random effects model was undertaken. Effect sizes are reported as Standardized Mean Difference (SMD). Prospero ID: 139835. RESULTS: From a total of 1312 individual studies, 14 RCTs were eligible for inclusion in the meta-analysis, total participant n = 937. Most studies included PwMS who remained ambulatory. Cognitively impaired PwMS were largely excluded. Comorbidities were inconsistently reported. Most MBIs were delivered face-to face in group format, but five were online. Eight studies (n = 8) measured MS-specific QoL. In meta-analysis, overall effect size (SMD) for any QoL measure (n = 14) was 0.40 (0.18-0.61), p = 0.0003, I2 = 52%. SMD for MS-specific QoL measures (n = 8) was 0.39 (0.21-0.57), p < 0.0001, I2 = 0%. MBI effect was largest on subscale measures of mental QoL (n = 8), SMD 0.70 (0.33-1.06), p = 0.0002, I2 = 63%. Adverse events were infrequently reported. CONCLUSIONS: MBIs effectively improve QoL in PwMS. The greatest benefits are on mental health-related QoL. However, more research is needed to characterize optimal formatting, mechanisms of action, and effects in PwMS with more diverse social, educational, and clinical backgrounds.

Experiences of health management among people at high risk of stroke in China: A qualitative study.

BACKGROUND: Effective health management of people at high risk of stroke in China is challenging. AIM: To explore and identify the experiences of health management among people at high risk of stroke in order to provide a foundation for a targeted health management strategy for this special group. DESIGN: A qualitative, descriptive study based on interviews. METHODS: Semistructured interviews were conducted with 31 people at high risk of stroke. The interviews were collated and analysed using Colaizzi's seven-step method. RESULTS: A total of 31 people at high risk of stroke were included, and the ages ranged from 40 to 86, with an average age of 60.71 (SD = 11.55). The experiences of health management were categorized into three themes. Theme 1: Facing many ongoing problems in health management, limited knowledge, lack of confidence and poor compliance. Theme 2: Accumulated some value experiences of coping with problems of health management, becoming active learners, promoting social interaction and enhancing self-health management. Theme 3: Sensitivity to multiple influencing factors, the severity of disease and complexity of disease management, family income and economic burden and the value of social support. CONCLUSIONS: This study explored the experiences of health management among people at high risk of stroke, and these findings are of great significance in the primary prevention of stroke.

Online Mindfulness with Care Partnerships Experiencing Anxiety and Depression Symptoms after Stroke: Mixed Methods Case Study Research.

Purpose: To investigate the experience and outcomes for care partnerships (e.g., spouses, caregivers) who have post-stroke anxiety and/or depression symptoms and used an online mindfulness-based intervention (MBI) together. Design: Explanatory sequential mixed methods case study research. Methods: 5 care partnerships (10 participants) received online MBI, and data was collected in weeks 0, 4, and 8. Data collection involved the Hospital Anxiety Depression Scale, the Mutuality Scale, the Mindful Attention Awareness Scale, and post-intervention interviews. Clinical effectiveness was evaluated using minimal clinically important difference (MCID). Findings: Participants improved mindfulness (80%) and mutuality (30%). MCID was achieved for anxiety symptoms (50%) and depression symptoms (20%). IPA found evidence of conflicting and contradictory experiences so dialectical tension was used to articulate the continuum of perspectives and themes produced in the analysis. Conclusion: Care partnerships using online MBIs can experience improvements in mindfulness, mutuality, anxiety symptoms, and depression symptoms. The findings are complex but show the potential value of online MBI for some care partnerships living with stroke.

Data resource profile: the virtual international care homes trials archive (VICHTA).

Introduction: Randomised controlled trials (RCTs) conducted in care home settings address a range of health conditions impacting older people, but often include a common core of data about residents and the care home environment. These data can be used to inform service provision, but accessing these data can be challenging. Methods: The Virtual International Care Home Trials Archive (VICHTA) collates care home RCTs conducted since 2010, with >100 participants, across multiple conditions, with documented eligibility criteria, initially identified from a scoping review. A Steering Committee comprising contributing trialists oversees proposed uses of fully anonymised data. We characterised available demography and outcomes to inform potential analyses. Data are accessible via application to the Virtual Trials Archives, through a secure online analysis platform. Trial recruitment is ongoing and future expansion will include international studies. Results: The first phase of VICHTA includes data from six UK RCTs, with individual participant data (IPD) on 5,674 residents across 308 care homes. IPD include age, sex, dementia status, length of stay, quality of life, clinical outcome measures, medications, resource use, and care home characteristics, such as funding, case mix, and occupancy. Follow-up ranges between four and sixteen months. Conclusions: VICHTA collates and makes accessible data on a complex and under-represented research population for novel analyses, and to inform design of future studies. Planned expansion to international care home RCTs will facilitate a wider range of research questions. Interested collaborators can submit trial data or request data at http://www.virtualtrialsarchives.org.

Stimulation of the tibial nerve-a randomised trial for urinary problems associated with Parkinson's-the STARTUP trial.

BACKGROUND: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. RESULTS: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome. CONCLUSION: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

Self-management of overactive bladder at home using transcutaneous tibial nerve stimulation: a qualitative study of women's experiences.

BACKGROUND: Transcutaneous tibial nerve stimulation (TTNS) has been used to treat overactive bladder (OAB), however patient experiences and views of this treatment are lacking. The aim of this study was to explore women's experiences of OAB and TTNS treatment and the perceived factors influencing participation and adherence. METHODS: Semi-structured, individual interviews conducted as part of a mixed-methods, randomised, feasibility trial of self-managed versus HCP-led TTNS. Interviews were audio recorded and transcribed verbatim. Reflexive thematic analysis was undertaken using Booth et al. (Neurourol Urodynam. 2017;37:528-41) approach. RESULTS: 16 women were interviewed, 8 self-managing TTNS at home and 8 receiving TTNS in twice-weekly hospital clinic appointments. Women self-managing OAB considered TTNS easy to administer, flexible and favourably 'convenient', especially when the participant was bound by work and other life commitments. In contrast to OAB symptoms 'dominating life', self-managing bladder treatment was empowering and fitted around home life demands. Flexibility and control engendered by self-management, facilitated women's willingness to participate in TTNS. Women attending a hospital clinic for TTNS enjoyed the social aspects but found the routine appointments constrained their lives. Motivation to continue TTNS in the longer term was dependent on perception of benefit. CONCLUSIONS: This study provides novel insights into women's experiences of self-managing their OAB using TTNS compared to HCP-led management in the clinical setting. It highlights positive experiences self-managing TTNS at home and a willingness to continue in the longer term, facilitated by ease of use and convenience. Trial Registration 1/11/2018: ClinicalTrials.gov Identifier: NCT03727711.

Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

OBJECTIVE: To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN: Parallel group randomised controlled trial. SETTING: 23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS: 600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone. INTERVENTIONS: Participants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments. MAIN OUTCOME MEASURES: The primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years. RESULTS: Mean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions. CONCLUSIONS: At 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated. TRIAL REGISTRATION: ISRCTN57756448.

Mission (im)possible: Engaging care homes, staff and residents in research studies.

OBJECTIVES: With increasing age the risk of institutionalization increases. To address the problem of underrepresentation of care homes and their residents in future research studies, we aimed to explore care home staff members' thoughts on barriers, challenges, facilitators and key aspects of engaging in research studies. METHODS: Five staff members from four care homes in Glasgow and Barcelona were interviewed. Transcription of the interviews was completed verbatim and an inductive thematic analysis was conducted to understand the difficulties and challenges they perceive for engaging in research studies. RESULTS: Three themes emerged that encapsulated the staff members' perspectives. 'Too much to deal with' included two subthemes; 'interested but with support' encapsulated four subthemes; and 'on the residents' terms' highlighted three subthemes. Staff members showed interest in engaging in research studies if a clear management support accompanied by a whole team approach was evident. The involvement of the resident's relatives was seen as essential if residents were to be supported to be engaged. CONCLUSIONS: Despite the small sample size, the perspectives of staff members, irrespective of country, provided valuable insights for informing researchers on best approaches to maximize care home and resident engagement in research.

Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson's disease-STARTUP.

INTRODUCTION: Parkinson's disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK. OBJECTIVES: Conduct a randomised controlled trial (RCT) targeting people with Parkinson's disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS. METHODS AND ANALYSIS: An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan ETHICS AND DISSEMINATION: East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN12437878; Pre-results.

Effects of Mindfulness-based interventions on physical symptoms in people with multiple sclerosis - a systematic review and meta-analysis.

BACKGROUND: Physical wellbeing is commonly impaired in people with multiple sclerosis (PwMS). This study aims to update our previous systematic review (2014) and conduct a meta-analysis on the efficacy of Mindfulness-based interventions (MBIs) for improving physical symptoms in PwMS. METHODS: In November 2017 we carried out systematic searches for eligible randomised controlled trials (RCTs) in seven major databases, updating our search in July 2018. We used medical subject headings and key words. Two independent reviewers used pre-defined criteria to screen, data extract, quality appraise, and analyse studies. The Cochrane Collaboration risk of bias tool was used to determine study quality. Physical wellbeing was the main outcome of interest. We used the random effects model for meta-analysis, reporting effect sizes as Standardised Mean Difference (SMD). This study is registered with PROSPERO: CRD42018093171. RESULTS: We identified 10 RCTs as eligible for inclusion in the systematic review (including 678 PwMS), whilst seven RCTs (555 PwMS) had data that could be used in our meta-analyses. In general, comorbidity, disability, ethnicity and socio-economic status were poorly reported. MBIs included manualised and tailored interventions, treatment duration 6-9 weeks, delivered face-to-face and online in groups and also individually. For fatigue, against any comparator SMD was 0.24 (0.08 - 0.41), I2=0%; against active comparators only, SMD was 0.10 (-0.14 - 0.34), I2=0%. For pain SMD was 0.16 (-0.46 - 0.79), I2=77%. Three adverse events occurred across all studies. CONCLUSIONS: MBIs appear to be an effective treatment for fatigue in PwMS. The optimal MBI in this context remains unclear. Further research into MBI optimisation, cost- and comparative-effectiveness is required.

Mindfulness-based interventions for mental well-being among people with multiple sclerosis: a systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: Impairment of mental well-being (anxiety, depression, stress) is common among people with multiple sclerosis (PwMS). Treatment options are limited, particularly for anxiety. The aim of this study was to update our previous systematic review (2014) and evaluate via meta-analysis the efficacy of mindfulness-based interventions (MBIs) for improving mental well-being in PwMS. METHODS: Systematic searches for eligible randomised controlled trials (RCTs) were carried out in seven major databases (November 2017, July 2018), using medical subject headings and key words. Studies were screened, data extracted, quality appraised and analysed by two independent reviewers, using predefined criteria. Study quality was assessed using the Cochrane Collaboration risk of bias tool. Mental well-being was the primary outcome. Random effects model meta-analysis was performed, with effect size reported as standardised mean difference (SMD). RESULTS: Twelve RCTs including 744 PwMS were eligible for inclusion in the systematic review, eight had data extractable for meta-analysis; n=635. Ethnicity, socioeconomic status, comorbidity and disability were inconsistently reported. MBIs varied from manualised to tailored versions, lasting 6-9 weeks, delivered individually and via groups, both in person and online. Overall SMD for mental well-being (eight studies) was 0.40 (0.28-0.53), p<0.01, I2=28%; against active comparators only (three studies) SMD was 0.17 (0.01-0.32), p<0.05, I2 =0%. Only three adverse events were reported. CONCLUSIONS: MBIs are effective at improving mental well-being in PwMS. More research is needed regarding optimal delivery method, cost-effectiveness and comparative-effectiveness. PROSPERO REGISTRATION NUMBER: CRD42018093171.

Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial.

INTRODUCTION: Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence. METHODS AND ANALYSIS: This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score. ETHICS AND DISSEMINATION: Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review. TRIAL REGISTRATION NUMBER: ISRCTN57746448; Pre-results.

Evaluating a hydration intervention (DRInK Up) to prevent urinary tract infection in care home residents: A mixed methods exploratory study.

OBJECTIVES: To investigate potential effects and acceptability of a theoretically driven hydration intervention (DRInK-Up), on the prevalence of urinary tract infections (UTIs), falls and emergency admissions in care home residents. METHODS: A single group pre-post evaluation design to test the DRInK-Up intervention, to increase fluid intake by 200-400ml daily. The number of UTIs, falls and emergency hospital admissions for each resident recorded over the DRInK-Up intervention period were compared to rates in the 24 weeks prior. A qualitative investigation of experiences of DRInK-Up was undertaken using focus group interviews with care home staff to determine acceptability. RESULTS: 24 care home residents took part in the intervention. There was a clinically meaningful, but non-statistically significant reduction in number of treated UTIs during the intervention period from 51 UTIs pre-DRInK-Up to 37 post-DRInK-Up (t= .498, 18df, p=0.625). The volume of fluid intake recorded was not correlated with number of UTIs (r= 0.103, p=.676). Falls reported dropped from 52 pre- to 28 post-intervention (t=3.148, df 19, p=0.005). Emergency admissions did not change. Focus group interviews suggested goal setting was uncommon and took the form of externally generated targets for fluid intake rather than negotiated goals. Barriers to increasing fluid intake included resident-related factors or arose from the care home context. A range of facilitators included verbal persuasion, praise and reward. CONCLUSION: The DRInK-Up study provides preliminary evidence suggesting that increasing daily fluid intake by small amounts may have a potentially positive effect on number of UTIs experienced and number of falls in frail older care home residents. Further research is needed.