Abstract Background Smoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and effectiveness of a smoking cessation intervention in comparison with usual care in people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Methods A pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary outcome is smoking status, as verified by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical fitness, cardiovascular risks, substance use, quality of life, and health-related self-efficacy at 12 months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both patients and mental health care professionals. Discussion The results of the KISMET trial will contribute to the evidence gap of effective smoking cessation interventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process of the intervention in current mental health care. The outcomes should advance the understanding of the interdependence of physical and mental health and the gradual integration of both within the mental health care system. Trial registration Netherlands Trial Register, NTR9783. Registered on 18 October 2021.
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Abstract Background Smoking among people with severe mental illness (SMI) is highly prevalent and strongly associated with poor physical health. Currently, evidence-based smoking cessation interventions are scarce and need to be integrated into current mental health care treatment guidelines and clinical practice. Therefore, the present study aims to evaluate the implementation and efectiveness of a smoking cessation intervention in comparison with usual care in people with SMI treated by Flexible Assertive Community Treatment (FACT) teams in the Netherlands. Methods A pragmatic, cluster-randomised controlled trial with embedded process evaluation will be conducted. Randomisation will be performed at the level of FACT teams, which will be assigned to the KISMET intervention or a control group (care as usual). The intervention will include pharmacological treatment combined with behavioural counselling and peer support provided by trained mental health care professionals. The intervention was developed using a Delphi study, through which a consensus was reached on the core elements of the intervention. We aim to include a total of 318 people with SMI (aged 18–65 years) who smoke and desire to quit smoking. The primary outcome is smoking status, as verifed by carbon monoxide measurements and self-report. The secondary outcomes are depression and anxiety, psychotic symptoms, physical ftness, cardiovascular risks, substance use, quality of life, and health-related self-efcacy at 12months. Alongside the trial, a qualitative process evaluation will be conducted to evaluate the barriers to and facilitators of its implementation as well as the satisfaction and experiences of both patients and mental health care professionals. Discussion The results of the KISMET trial will contribute to the evidence gap of efective smoking cessation interventions for people treated by FACT teams. Moreover, insights will be obtained regarding the implementation process of the intervention in current mental health care. The outcomes should advance the understanding of the interdependence of physical and mental health and the gradual integration of both within the mental health care system. Trial registration Netherlands Trial Register, NTR9783. Registered on 18 October 2021.
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Background: Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient’s acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is costeffective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS. Methods: A randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30–45 min each, delivered by a specialised exercise or physical therapist. Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months. An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted. Discussion: We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.Trial registration: Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.Keywords: Psychosomatic therapy, Study protocol, Primary care, Randomised controlled trial, Medically unexplained symptoms, Cost-effectiveness
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Background Running-related injuries (RRIs) can be considered the primary enemy of runners. Most literature on injury prediction and prevention overlooks the mental aspects of overtraining and under-recovery, despite their potential role in injury prediction and prevention. Consequently, knowledge on the role of mental aspects in RRIs is lacking. Objective To investigate mental aspects of overtraining and under-recovery by means of an online injury prevention programme. Methods and analysis The ‘Take a Mental Break!’ study is a randomised controlled trial with a 12 month follow-up. After completing a web-based baseline survey, half and full marathon runners were randomly assigned to the intervention group or the control group. Participants of the intervention group obtained access to an online injury prevention programme, consisting of a running-related smartphone application. This app provided the participants of the intervention group with information on how to prevent overtraining and RRIs with special attention to mental aspects. The primary outcome measure is any self-reported RRI over the past 12 months. Secondary outcome measures include vigour, fatigue, sleep and perceived running performance. Regression analysis will be conducted to investigate whether the injury prevention programme has led to a lower prevalence of RRIs, better health and improved perceived running performance. Ethics and dissemination The Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands, has exempted the current study from ethical approval (reference number: NL64342.041.17). Results of the study will be communicated through scientific articles in peer-reviewed journals, scientific reports and presentations on scientific conferences.
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BackgroundFluid therapy is a common intervention in critically ill patients. It is increasingly recognised that deresuscitation is an essential part of fluid therapy and delayed deresuscitation is associated with longer invasive ventilation and length of intensive care unit (ICU) stay. However, optimal timing and rate of deresuscitation remain unclear. Lung ultrasound (LUS) may be used to identify fluid overload. We hypothesise that daily LUS-guided deresuscitation is superior to deresuscitation without LUS in critically ill patients expected to undergo invasive ventilation for more than 24 h in terms of ventilator free-days and being alive at day 28.MethodsThe “effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients” (CONFIDENCE) is a national, multicentre, open-label, randomised controlled trial (RCT) in adult critically ill patients that are expected to be invasively ventilated for at least 24 h. Patients with conditions that preclude a negative fluid balance or LUS examination are excluded. CONFIDENCE will operate in 10 ICUs in the Netherlands and enrol 1000 patients. After hemodynamic stabilisation, patients assigned to the intervention will receive daily LUS with fluid balance recommendations. Subjects in the control arm are deresuscitated at the physician’s discretion without the use of LUS. The primary endpoint is the number of ventilator-free days and being alive at day 28. Secondary endpoints include the duration of invasive ventilation; 28-day mortality; 90-day mortality; ICU, in hospital and total length of stay; cumulative fluid balance on days 1–7 after randomisation and on days 1–7 after start of LUS examination; mean serum lactate on days 1–7; the incidence of reintubations, chest drain placement, atrial fibrillation, kidney injury (KDIGO stadium ≥ 2) and hypernatremia; the use of invasive hemodynamic monitoring, and chest-X-ray; and quality of life at day 28.DiscussionThe CONFIDENCE trial is the first RCT comparing the effect of LUS-guided deresuscitation to routine care in invasively ventilated ICU patients. If proven effective, LUS-guided deresuscitation could improve outcomes in some of the most vulnerable and resource-intensive patients in a manner that is non-invasive, easy to perform, and well-implementable.Trial registrationClinicalTrials.gov NCT05188092. Registered since January 12, 2022
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BACKGROUND: It is unclear if psycho-education on top of physical training is of additional value regarding quality of life in revascularised patients.DESIGN: Prospective randomised study comparing two types of cardiac rehabilitation: exercise based versus a more comprehensive approach including psychological therapy.METHODS: One hundred and thirty-seven male patients who underwent an uncomplicated coronary revascularisation procedure and who were mentally in a good condition, were randomised to one of two types of cardiac rehabilitation: physical training plus information about their disease ('Fit' program) during 6 weeks or comprehensive cardiac rehabilitation which, on top of the Fit-program, included weekly psycho-education sessions and relaxation therapy ('Fit-Plus' program) for 8 weeks. One hundred and four patients were analysed. Quality of life was measured by the 'Leiden Quality of Life questionnaire' and by the RAND-36 (quality of life) questionnaire.RESULTS: Quality of life improved in both treatment groups in the course of time up to 9 months after cardiac rehabilitation and there was no difference between the two types of cardiac rehabilitation. Exercise capacity improved likewise, blood lipid profile was unaffected and energy intake decreased in each treatment group but, again, there were no inter-group differences.CONCLUSION: After an uncomplicated revascularisation procedure, physical training plus information results in a comparable outcome on quality of life when compared to a more comprehensive program including additional psycho-education and relaxation therapy.
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Non-pharmacological interventions such as mirror therapy are gaining increased recognition in the treatment of phantom limb pain; however, the evidence in people with phantom limb pain is still weak. In addition, compliance to self-delivered exercises is generally low. The aim of this randomised controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and limitations in daily activities compared to traditional mirror therapy and care as usual in people following lower limb amputation.
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The Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study is the first randomised controlled trial investigating anterior discectomy with fusion versus foraminotomy for cervical foraminal pathology. Methodological strengths include an appropriate sample size based on a non-inferiority design, seven participating medical centres and an independent institute facilitating the randomisation system and monitoring activities. The study is performed with care as usual; therefore, the final results of this study could be generalisable to usual clinical practice. With respect to the evaluation of spinal fusion and instrumentation failure, the relatively short follow-up period of 2 years could be a limitation of this study. In this study, it is not feasible to blind the participant and the surgeon to the allocated treatment. Alleen toegang via de link.
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Background: According to the principles of Reablement, home care services are meant to be goal-oriented, holistic and person-centred taking into account the capabilities and opportunities of older adults. However, home care services traditionally focus on doing things for older adults rather than with them. To implement Reablement in practice, the ‘Stay Active at Home’ programme was developed. It is assumed that the programme leads to a reduction in sedentary behaviour in older adults and consequently more cost-effective outcomes in terms of their health and wellbeing. However, this has yet to be proven. Methods/ design: A two-group cluster randomised controlled trial with 12 months follow-up will be conducted. Ten nursing teams will be selected, pre-stratified on working area and randomised into an intervention group (‘Stay Active at Home’) or control group (no training). All nurses of the participating teams are eligible to participate in the study. Older adults and, if applicable, their domestic support workers (DSWs) will be allocated to the intervention or control group as well, based on the allocation of the nursing team. Older adults are eligible to participate, if they: 1) receive homecare services by the selected teams; and 2) are 65 years or older. Older adults will be excluded if they: 1) are terminally ill or bedbound; 2) have serious cognitive or psychological problems; or 3) are unable to communicate in Dutch. DSWs are eligible to participate if they provide services to clients who fulfil the eligibility criteria for older adults. The study consists of an effect evaluation (primary outcome: sedentary behaviour in older adults), an economic evaluation and a process evaluation. Data for the effect and economic evaluation will be collected at baseline and 6 and/or 12 months after baseline using performance-based and self-reported measures. In addition, data from client records will be extracted. A mixed-methods design will be applied for the process evaluation, collecting data of older adults and professionals throughout the study period. Discussion: This study will result in evidence about the effectiveness, cost-effectiveness and feasibility of the ‘Stay Active at Home’ programme.
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Abstract Background Clients with severe mental illness (SMI) have overall poor physical health. SMI reduces life expectancy by 5–17 years, primarily due to physical comorbidity linked to cardiometabolic risks that are mainly driven by unhealthy lifestyle behaviours. To improve physical health in clients with SMI, key elements are systematic somatic screening and lifestyle promotion. The nurse-led GILL eHealth was developed for somatic screening and the imple‑ mentation of lifestyle activities in clients with SMI. Aims of this study are to evaluate the efectiveness of the GILL eHealth intervention in clients with SMI compared to usual care, and to evaluate the implementation process, and the experiences of clients and healthcare providers with GILL eHealth. Methods The GILL study encompasses a cluster-randomised controlled trial in approximately 20 mental health care facilities in the Netherlands. The randomisation takes place at the team level, assigning clients to the eHealth inter‑ vention or the usual care group. The GILL eHealth intervention consists of two complementary modules for somatic screening and lifestyle promotion, resulting in personalised somatic treatment and lifestyle plans. Trained mental health nurses and nurse practitioners will implement the intervention within the multidisciplinary treatment context, and will guide and support the participants in promoting their physical health, including cardiometabolic risk management. Usual care includes treatment as currently delivered, with national guidelines as frame of reference. We aim to include 258 clients with SMI and a BMI of 27 or higher. Primary outcome is the metabolic syndrome severity score. Secondary outcomes are physical health measurements and participants’ reports on physical activity, perceived lifestyle behaviours, quality of life, recovery, psychosocial functioning, and health-related self-efcacy. Measurements will be completed at baseline and at 6 and 12 months. A qualitative process evaluation will be conducted alongside, to evaluate the process of implementation and the experiences of clients and healthcare professionals with GILL eHealth. Discussion The GILL eHealth intervention is expected to be more efective than usual care in improving physical health and lifestyle behaviours among clients with SMI. It will also provide important information on implementation of GILL eHealth in mental health care. If proven efective, GILL eHealth ofers a clinically useful tool to improve physical health and lifestyle behaviours.
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