The role of the healthcare assistant on a stroke unit: A scoping review.

OBJECTIVE: This scoping review explores the role of a healthcare assistant on a stroke unit, potential barriers to role fulfilment and whether stroke-specific training could enhance rehabilitative practice. DATA SOURCES: Searches were conducted on CINAHL, MEDLINE and APA PsycInfo in May 2021 and repeated in September 2022. METHODS: This scoping review was guided by Arksey and O'Malley's framework. Article selection and data extraction were conducted by one researcher using a structured proforma. A narrative approach to data synthesis was undertaken following the research questions. RESULTS: From a combined total of 533 articles, sixty-six full-text articles were assessed for eligibility. Sixteen full articles were included in this review. A healthcare assistants' role was viewed as caring directly for patients - some individuals felt they contributed to rehabilitation during these tasks, and that they could be undervalued by multidisciplinary team members, patients and their families. The barriers identified to healthcare assistants' role fulfilment were lack of time, training and staffing shortages. Training was perceived to improve healthcare assistants' communication, confidence and knowledge but training needed to be flexible, ward based and accommodate staffing shortages. However, it is unclear whether training has any clinical benefit for patients. CONCLUSION: Healthcare assistants are well placed to enhance rehabilitative practice with patients; however, there are clear perceived barriers to this occurring. Future research should aim to define the role of healthcare assistants and explore whether further stroke-specific training could cause clinical benefits for patients.

Using consensus methods to prioritize modifiable risk factors for development of manifestations of frailty in hospitalized older adults.

AIM: The aim of the study was to reach consensus on modifiable risk factors for a novel system of care to address Manifestations of Frailty in hospitalized older adults. DESIGN: Consensus study. METHOD: A modified nominal group technique, incorporating expert group face-to-face interaction, review of existing evidence and pre/post-meeting questionnaire completion was undertaken November 2019-February 2020. RESULTS: Seventy-one risk factors, within seven risk factor domains (pain, medication, fluid and nutrition intake, mobility, elimination, infection, additional patient factors) were considered. It was agreed that 44 risk factors incorporating patient, organizational and environmental risk factors were modifiable and should be included in a novel system of care.

HABIT: Health visitors delivering Advice in Britain on Infant Toothbrushing - an early-phase feasibility study of a complex oral health intervention.

OBJECTIVES: To conduct an early-phase feasibility study of an oral health intervention, Health visitors delivering Advice on Britain on Infant Toothbrushing (HABIT), delivered by Health Visitors to parents of children aged 9-12 months old. DESIGN: A mixed-methods, early-phase, non-controlled, feasibility study. PARTICIPANTS: Recruitment consisted of Group A-HABIT-trained Health Visitors (n=11) and Group B-parents of children aged 9-12 months old about to receive their universal health check (n=35). SETTING: Bradford, West Yorkshire, UK. INTERVENTION: A multidisciplinary team co-developed digital and paper-based training resources with health visitors and parents of young children. The intervention comprised of two components: (A) training for health visitors to deliver the HABIT intervention and (B) HABIT resources for parents, including a website, videos, toothbrushing demonstration and a paper-based leaflet with an oral health action plan. PRIMARY AND SECONDARY OUTCOME MEASURES: Recruitment, retention and intervention delivery were analysed as key process outcomes for Groups A and B. Group B demographics, self-reported toothbrushing behaviours, dietary habits and three objective measures of toothbrushing including plaque scores were collected at baseline, 2 weeks and 3 months post intervention. RESULTS: HABIT intervention delivery was feasible. Although the intended sample size was recruited (Group A=11 and Group B=35) it was more challenging than anticipated. Retention of Group B participants to final data collection was satisfactory (n=26). Total compliance with toothbrushing guidelines at baseline was low (30%), but significantly improved and was maintained 3 months after the intervention (68%). Plaque scores improved post intervention and participants found video recording of toothbrushing acceptable. Dietary habits remained largely unchanged. CONCLUSION: This feasibility study has demonstrated that HABIT is an appropriate oral health intervention. Adaptions to the study design are recommended to maximise recruitment and data collection in a definitive study. These quantitative findings have demonstrated an early signal of impact for improved oral health behaviours for young children at high risk of decay. TRIAL REGISTRATION NUMBER: ISRCTN55332414.

Co-design of an oral health intervention (HABIT) delivered by health visitors for parents of children aged 9-12 months.

BACKGROUND: Dental caries (tooth decay) in children is a national public health problem with impacts on the child, their family and wider society. Toothbrushing should commence from the eruption of the first primary tooth. Health visitors are a key provider of advice for parents in infancy and are ideally placed to support families to adopt optimal oral health habits. HABIT is a co-designed complex behaviour change intervention to support health visitors' oral health conversations with parents during the 9-12-month universal developmental home visit. METHODS: A seven stage co-design process was undertaken: (1) Preparatory meetings with healthcare professionals and collation of examples of good practice, (2) Co-design workshops with parents and health visitors, (3) Resource development and expert/peer review, (4) Development of an intervention protocol for health visitors, (5) Early-phase testing of the resources to explore acceptability, feasibility, impact and mechanism of action, (6) Engagement with wider stakeholders and refinement of the HABIT intervention for wider use, (7) Verification, Review and Reflection of Resources. RESULTS: Following preparatory meetings with stakeholders, interviews and co-design workshops with parents and health visitors, topic areas and messages were developed covering six key themes. The topic areas provided a structure for the oral health conversation and supportive resources in paper-based and digital formats. A five-step protocol was developed with health visitors to guide the oral health conversation during the 9-12 month visit. Following training of health visitors, an early-phase feasibility study was undertaken with preliminary results presented at a dissemination event where feedback for further refinement of the resources and training was gathered. The findings, feedback and verification have led to further refinements to optimise quality, accessibility, fidelity and behaviour change theory. CONCLUSION: The co-design methods ensured the oral health conversation and supporting resources used during the 9-12 month visit incorporated the opinions of families and Health Visitors as well as other key stakeholders throughout the development process. This paper provides key learning and a framework that can be applied to other healthcare settings. The structured pragmatic approach ensured that the intervention was evidence-based, acceptable and feasible for the required context. TRIAL REGISTRATION: ISRCTN55332414, Registration Date 11/11/2021.

HABIT (Health visitors delivering Advice in Britain on Infant Toothbrushing): a qualitative exploration of the acceptability of a complex oral health intervention.

BACKGROUND: To explore the acceptability of the oral health intervention, HABIT (Health visitors delivering Advice in Britain on Infant Toothbrushing) to parents with young children aged 9-12 months and health visitors. METHODS: Following the delivery of the universal oral health intervention called HABIT, qualitative semi-structured interviews with parents and focus groups with health visitors were undertaken. Interviews were audio-recorded and transcribed. Health visitors completed self-reported diaries after delivering the HABIT intervention with parents. The qualitative data was analysed using framework analysis (guided by a theoretical framework of acceptability). RESULTS: Seventeen parents were interviewed, and five health visitors and three nursery nurses participated in two focus groups. Parents reported health visitors to be 'trusted' and valued the reassurance provided during the HABIT visit. Health visitors found the HABIT training and resources useful and valued the consistency and increased confidence in undertaking oral health conversations. There were, however, challenges in changing behaviour where families faced competing demands on time and resources. Both health visitors and parents described the importance of the intervention's timing and suggested that multiple visits may be needed to support optimal oral health habits. CONCLUSION: The HABIT intervention was acceptable to parents and health visitors. Health visitors would welcome a further refinement to enhance intervention delivery that specifically achieves a balance between using a guided script and retaining the flexibility to adapt the conversation to suit the needs of individual families. This, in turn, will maximise impact and enable parents of young children to adopt and maintain optimal home-based oral health behaviours for their child.

Risk factors for manifestations of frailty in hospitalized older adults: A qualitative study.

AIMS: To explore the experiences of older people and ward staff to identify modifiable factors (risk factors) which have the potential to reduce development or exacerbation of manifestations of frailty during hospitalization. To develop a theoretical framework of modifiable risk factors. DESIGN: Qualitative descriptive study. METHODS: Qualitative interviews with recently discharged older people (n = 18) and focus groups with ward staff (n = 22) were undertaken between July and October 2019. Data were analysed using directed content analysis. RESULTS: Themes identified related to attitude to risk, communication and, loss of routine, stimulation and confidence. Using findings from this study and previously identified literature, we developed a theoretical framework including 67 modifiable risk factors. Risk factors are grouped by patient risk factor domains (pain, medication, nutritional/fluid intake, mobility, elimination, infection, additional patient risk factors) and linked care management sub-domains (including risk factors relating to the ward environment, process of care, ward culture or broader organizational set up). Many of the additional 36 risk factors identified by this study were related to care management sub-domains. CONCLUSION: A co-ordinated approach is needed to address modifiable risk factors which lead to the development or exacerbation of manifestations of frailty in hospitalized older people. Risk assessment and management practices should not be duplicative and, should recognize and address modifiable risk factors which occur at the ward and organizational level. IMPACT: Some older people leave hospital more dependent than when they come in and this is, in part, due to the environment and process of care and not just the severity of their presenting illness. Many of the risk factors identified need to be addressed at an organizational rather than individual level. Findings will inform a programme of research to develop and test a novel system of care aimed at preventing loss of independence in hospitalized older people.

Information provision for stroke survivors and their carers.

BACKGROUND: A stroke is a sudden loss of brain function caused by lack of blood supply. Stroke can lead to death or physical and cognitive impairment and can have long lasting psychological and social implications. Research shows that stroke survivors and their families are dissatisfied with the information provided and have a poor understanding of stroke and associated issues. OBJECTIVES: The primary objective is to assess the effects of active or passive information provision for stroke survivors (people with a clinical diagnosis of stroke or transient ischaemic attack (TIA)) or their identified carers. The primary outcomes are knowledge about stroke and stroke services, and anxiety. SEARCH METHODS: We updated our searches of the Cochrane Stroke Group Specialised Register on 28 September 2020 and for the following databases to May/June 2019: the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 5) and the Cochrane Database of Systematic Reviews (CDSR; 2019, Issue 5) in the Cochrane Library (searched 31 May 2019), MEDLINE Ovid (searched 2005 to May week 4, 2019), Embase Ovid (searched 2005 to 29 May 2019), CINAHL EBSCO (searched 2005 to 6 June 2019), and five others. We searched seven study registers and checked reference lists of reviews. SELECTION CRITERIA: Randomised trials involving stroke survivors, their identified carers or both, where an information intervention was compared with standard care, or where information and another therapy were compared with the other therapy alone, or where the comparison was between active and passive information provision without other differences in treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial eligibility and risk of bias, and extracted data. We categorised interventions as either active information provision or passive information provision: active information provision included active participation with subsequent opportunities for clarification and reinforcement; passive information provision provided no systematic follow-up or reinforcement procedure. We stratified analyses by this categorisation. We used GRADE methods to assess the overall certainty of the evidence. MAIN RESULTS: We have added 12 new studies in this update. This review now includes 33 studies involving 5255 stroke-survivor and 3134 carer participants. Twenty-two trials evaluated active information provision interventions and 11 trials evaluated passive information provision interventions. Most trials were at high risk of bias due to lack of blinding of participants, personnel, and outcome assessors where outcomes were self-reported. Fewer than half of studies were at low risk of bias regarding random sequence generation, concealment of allocation, incomplete outcome data or selective reporting. The following estimates have low certainty, based on the quality of evidence, unless stated otherwise. Accounting for certainty and size of effect, analyses suggested that for stroke survivors, active information provision may improve stroke-related knowledge (standardised mean difference (SMD) 0.41, 95% confidence interval (CI) 0.17 to 0.65; 3 studies, 275 participants), may reduce cases of anxiety and depression slightly (anxiety risk ratio (RR) 0.85, 95% CI 0.68 to 1.06; 5 studies, 1132 participants; depression RR 0.83, 95% CI 0.68 to 1.01; 6 studies, 1315 participants), may reduce Hospital Anxiety and Depression Scale (HADS) anxiety score slightly, (mean difference (MD) -0.73, 95% CI -1.10 to -0.36; 6 studies, 1171 participants), probably reduces HADS depression score slightly (MD (rescaled from SMD) -0.8, 95% CI -1.27 to -0.34; 8 studies, 1405 participants; moderate-certainty evidence), and may improve each domain of the World Health Organization Quality of Life assessment short-form (WHOQOL-BREF) (physical, MD 11.5, 95% CI 7.81 to 15.27; psychological, MD 11.8, 95% CI 7.29 to 16.29; social, MD 5.8, 95% CI 0.84 to 10.84; environment, MD 7.0, 95% CI 3.00 to 10.94; 1 study, 60 participants). No studies evaluated positive mental well-being. For carers, active information provision may reduce HADS anxiety and depression scores slightly (MD for anxiety -0.40, 95% CI -1.51 to 0.70; 3 studies, 921 participants; MD for depression -0.30, 95% CI -1.53 to 0.92; 3 studies, 924 participants), may result in little to no difference in positive mental well-being assessed with Bradley's well-being questionnaire (MD -0.18, 95% CI -1.34 to 0.98; 1 study, 91 participants) and may result in little to no difference in quality of life assessed with a 0 to 100 visual analogue scale (MD 1.22, 95% CI -7.65 to 10.09; 1 study, 91 participants). The evidence is very uncertain (very low certainty) for the effects of active information provision on carers' stroke-related knowledge, and cases of anxiety and depression. For stroke survivors, passive information provision may slightly increase HADS anxiety and depression scores (MD for anxiety 0.67, 95% CI -0.37 to 1.71; MD for depression 0.39, 95% CI -0.61 to 1.38; 3 studies, 227 participants) and the evidence is very uncertain for the effects on stroke-related knowledge, quality of life, and cases of anxiety and depression. For carers, the evidence is very uncertain for the effects of passive information provision on stroke-related knowledge, and HADS anxiety and depression scores. No studies of passive information provision measured carer quality of life, or stroke-survivor or carer positive mental well-being. AUTHORS' CONCLUSIONS: Active information provision may improve stroke-survivor knowledge and quality of life, and may reduce anxiety and depression. However, the reductions in anxiety and depression scores were small and may not be important. In contrast, providing information passively may slightly worsen stroke-survivor anxiety and depression scores, although again the importance of this is unclear. Evidence relating to carers and to other outcomes of passive information provision is generally very uncertain. Although the best way to provide information is still unclear, the evidence is better for strategies that actively involve stroke survivors and carers and include planned follow-up for clarification and reinforcement.

Development of a self-management intervention for stroke survivors with aphasia using co-production and behaviour change theory: An outline of methods and processes.

BACKGROUND: Self-management is a promising approach to improve quality of life after stroke. However, evidence for the appropriateness and effectiveness of self-management for stroke survivors with aphasia is limited. This article reports on the process used to develop a supported self-management intervention for stroke survivors with aphasia (SSWA) using co-production and behaviour change theory. Preparatory research included systematic reviews, and qualitative interviews and focus groups with SSWA, family members and speech and language therapists (SLTs). MATERIALS AND METHODS: We conducted six, 2 hour long intervention development workshops with key stakeholders. The workshops were informed by principles of co-production and the intervention development process outlined by the Behaviour Change Wheel (BCW). We also incorporated the findings of our preparatory research within workshops. Each workshop included an introduction, 1-2 co-production tasks and time for feedback at the end of the session. Data were analysed on an ongoing basis so that findings could be used to feed in to subsequent workshops and intervention development. RESULTS: Workshop participants (n = 12) included; SSWA (n = 5), family members (n = 3) and SLTs (n = 4). Together, participants engaged with accessible and participatory co-production tasks which aligned with the BCW framework. Participants engaged in discussion to define self-management in behavioural terms (behavioural diagnosis) and to identify what needed to change to support self-management. Participant's co-produced solutions for supporting self-management and discussed options to implement these in practice. Prototype materials were generated by the research team and evaluated by participants. Intervention functions and behaviour change techniques (BCTs) were mapped to the solutions generated by participants by the research team, after the final workshop. A supported self-management intervention for SSWA was developed which will be delivered by SLTs through community stroke services. CONCLUSIONS: This paper reports the process we used to integrate co-production work with behaviour change theory to develop a complex self-management intervention. This is of relevance for researchers looking to harness the strengths of co-production methods and theory in intervention design. Future research will feasibility test the supported self-management intervention developed. This paper provides transparency to our intervention development process which will help others to better interpret the findings of our feasibility work.

Experiences and views of receiving and delivering information about recovery in acquired neurological conditions: a systematic review of qualitative literature.

OBJECTIVE: To review and synthesise qualitative literature relating to the views, perceptions and experiences of patients with acquired neurological conditions and their caregivers about the process of receiving information about recovery; as well as the views and experiences of healthcare professionals involved in delivering this information. DESIGN: Systematic review of qualitative studies. DATA SOURCES: MEDLINE, Embase, AMED, CINAHL, PsycINFO, Web of Science and the Cochrane library were searched from their inception to July 2019. DATA EXTRACTION AND SYNTHESIS: Two reviewers extracted data from the included studies and assessed quality using an established tool. Thematic synthesis was used to synthesise the findings of included studies. RESULTS: Searches yielded 9105 titles, with 145 retained for full-text screening. Twenty-eight studies (30 papers) from eight countries were included. Inductive analysis resulted in 11 descriptive themes, from which 5 analytical themes were generated: the right information at the right time; managing expectations; it's not what you say, it's how you say it; learning how to talk about recovery and manage emotions; the context of uncertainty. CONCLUSIONS: Our findings highlight the inherent challenges in talking about recovery in an emotional context, where breaking bad news is a key feature. Future interventions should focus on preparing staff to meet patients' and families' information needs, as well as ensuring they have the skills to discuss potential recovery and break bad news compassionately and share the uncertain trajectory characteristic of acquired neurological conditions. An agreed team-based approach to talking about recovery is recommended to ensure consistency and improve the experiences of patients and their families.

How do stroke survivors with communication difficulties manage life after stroke in the first year? A qualitative study.

BACKGROUND: Interest in how stroke survivors might be better supported to manage life after stroke has grown rapidly in recent years, with a particular emphasis on enabling 'self-management'. Post-stroke communication difficulties may pose a unique barrier to longer term adaptation and adjustment. It is important to understand how stroke survivors with communication difficulties manage life after stroke and what support may be needed to facilitate this process. AIMS: To explore how stroke survivors with communication difficulties manage life after stroke in the first year. METHODS & PROCEDURES: A cross-sectional qualitative study involving in-depth semi-structured interviews with stroke survivors with communication difficulties (aphasia, dysarthria or apraxia of speech) and/or their family members at single time points during the first year post-stroke. A total of 21 participants (14 stroke survivors and seven family members) took part in interviews for the study. Interview data were analysed using thematic analysis. OUTCOME & RESULTS: A total of six themes were identified: (1) strategies to manage changes to communication; (2) testing communication outside of the home; (3) balancing support and independence; (4) hope for recovery; (5) obtaining support from healthcare professionals; and (6) adapting activities and keeping busy. Stroke survivors with communication difficulties and their family members undertook significant work (practical, relational, emotional) to manage their condition. Adaptation and adjustment was often facilitated by 'doing'; testing out which activities could be managed independently and which required additional support. Some stroke survivors and their family members demonstrated considerable resourcefulness and creativity in developing strategies to manage their communication difficulties. Despite the work undertaken, many expressed a lack of confidence in their ability and feelings of powerlessness and abandonment at the point of discharge from community services. CONCLUSIONS & IMPLICATIONS: Stroke survivors and their family members develop personally meaningful and context-specific strategies to adjust to and manage life after stroke. Future interventions should recognize, support and build upon the active work already undertaken by stroke survivors with communication difficulties and their families. Further support before and around the point of discharge from community services may be needed to help build confidence and skills to manage in the longer term. The benefit of a supported self-management approach for stroke survivors with communication difficulties should be further investigated.

Post-stroke self-management interventions: a systematic review of effectiveness and investigation of the inclusion of stroke survivors with aphasia.

PURPOSE: To systematically review self-management interventions to determine their efficacy for people with stroke in relation to any health outcome and to establish whether stroke survivors with aphasia were included. METHOD: We searched MEDLINE, EMBASE, PsycINFO, CINAHL, The Cochrane Library, and IBSS and undertook gray literature searches. Randomized controlled trials were eligible if they included stroke survivors aged 18 + in a "self-management" intervention. Data were extracted by two independent researchers and included an assessment of methodological quality. RESULTS: 24 studies were identified. 11 out of 24 reported statistically significant benefits in favor of self-management. However, there were significant limitations in terms of methodological quality, and meta-analyses (n= 8 studies) showed no statistically significant benefit of self-management upon global disability and stroke-specific quality of life at 3 months or ADL at 3 or 6 months follow-up. A review of inclusion and exclusion criteria showed 11 out of 24 (46%) studies reported total or partial exclusion of stroke survivors with aphasia. Four out of 24 (17%) reported the number of stroke survivors with aphasia included. In nine studies (38%) it was unclear whether stroke survivors with aphasia were included or excluded. CONCLUSIONS: Robust conclusions regarding the effectiveness of poststroke self-management approaches could not be drawn. Further trials are needed, these should clearly report the population included. Implications for rehabilitation There is a lack of evidence to demonstrate the effectiveness of self-management approaches for stroke survivors. It is unclear whether self-management approaches are suitable for stroke survivors with aphasia, particularly those with moderate or severe aphasia. Further research is needed to understand the optimal timing for self-management in the stroke pathway and the format in which self-management support should be offered.

Longer-term needs of stroke survivors with communication difficulties living in the community: a systematic review and thematic synthesis of qualitative studies.

OBJECTIVE: To review and synthesise qualitative literature relating to the longer-term needs of community dwelling stroke survivors with communication difficulties including aphasia, dysarthria and apraxia of speech. DESIGN: Systematic review and thematic synthesis. METHOD: We included studies employing qualitative methodology which focused on the perceived or expressed needs, views or experiences of stroke survivors with communication difficulties in relation to the day-to-day management of their condition following hospital discharge. We searched MEDLINE, EMBASE, PsycINFO, CINAHL, The Cochrane Library, International Bibliography of the Social Sciences and AMED and undertook grey literature searches. Studies were assessed for methodological quality by two researchers independently and the findings were combined using thematic synthesis. RESULTS: Thirty-two studies were included in the thematic synthesis. The synthesis reveals the ongoing difficulties stroke survivors can experience in coming to terms with the loss of communication and in adapting to life with a communication difficulty. While some were able to adjust, others struggled to maintain their social networks and to participate in activities which were meaningful to them. The challenges experienced by stroke survivors with communication difficulties persisted for many years poststroke. Four themes relating to longer-term need were developed: managing communication outside of the home, creating a meaningful role, creating or maintaining a support network and taking control and actively moving forward with life. CONCLUSIONS: Understanding the experiences of stroke survivors with communication difficulties is vital for ensuring that longer-term care is designed according to their needs. Wider psychosocial factors must be considered in the rehabilitation of people with poststroke communication difficulties. Self-management interventions may be appropriate to help this subgroup of stroke survivors manage their condition in the longer-term; however, such approaches must be designed to help survivors to manage the unique psychosocial consequences of poststroke communication difficulties.

Cost and outcome of behavioural activation versus cognitive behavioural therapy for depression (COBRA): a qualitative process evaluation.

OBJECTIVE: To explore participant views on acceptability, mechanisms of change and impact of behavioural activation (BA) delivered by junior mental health workers (MHWs) versus cognitive behavioural therapy (CBT) delivered by professional psychotherapists. DESIGN: Semistructured qualitative interviews analysed using a framework approach. PARTICIPANTS: 36 participants with major depressive disorder purposively sampled from a randomised controlled trial of BA versus CBT (the COBRA trial). SETTING: Primary care psychological therapies services in Devon, Durham and Leeds, UK. RESULTS: Elements of therapy considered to be beneficial included its length and regularity, the opportunity to learn and not dwelling on the past. Homework was an important, although challenging aspect of treatment. Therapists were perceived as experts who played an important role in treatment. For some participants the most important element of therapy was having someone to talk to, but for others the specific factors associated with BA and CBT were crucial, with behavioural change considered important for participants in both treatments, and cognitive change unsurprisingly discussed more by those receiving CBT. Both therapies were considered to have a positive impact on symptoms of depression and other areas of life including feelings about themselves, self-care, work and relationships. Barriers to therapy included work, family life and emotional challenges. A subset (n=2) of BA participants commented that therapy felt too simple, and MHWs could be perceived as inexperienced. Many participants saw therapy as a learning experience, providing them with tools to take away, with work on relapse prevention essential. CONCLUSIONS: Despite barriers for some participants, BA and CBT were perceived to have many benefits, to have brought about cognitive and behavioural change and to produce improvements in many domains of participants' lives. To optimise the delivery of BA, inexperienced junior MHWs should be supported through good quality training and ongoing supervision. TRIAL REGISTRATION NUMBER: ISRCTN27473954, 09/12/2011.