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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Het doel van de klinische forensische zorg, of meer specifiek de tbs-maatregel, is het beveiligen van de maatschappij; op korte termijn door iemand uit de maatschappij te halen en op langere termijn door behandeling gericht op het verlagen van risicofactoren en het opbouwen of versterken van beschermende factoren. In de media verschijnen met enige regelmaat kritische verhalen over de forensische zorg, meestal naar aanleiding van een ernstig incident, zoals een delict gepleegd door een tbs-patiënt op verlof. De vraag die daarbij steeds wordt opgeworpen, is hoe effectief de tbs-maatregel en behandeling in de forensische zorg is. Het is logisch dat er maatschappelijke onrust ontstaat bij ernstige incidenten en de opgeworpen vragen vanuit de maatschappij zijn terecht. Toch is enige nuancering hier op zijn plaats, aangezien recidive tijdens forensische behandeling uitzonderlijk is. Zo werd in een recent onderzoek met gegevens van het Adviescollege Verloftoetsing tbs (AVT) gevonden dat slechts bij 0,15% van de 15.050 positief beoordeelde verlofaanvragen sprake was van een ongeoorloofde afwezigheid met recidive. Verder blijkt al jaren uit onderzoek van het Wetenschappelijk Onderzoek- en Datacentrum (WODC) dat ernstige recidive na ontslag uit de forensische zorg, met name de tbs, relatief laag is, in ieder geval aanzienlijk lager dan na een gevangenisstraf. Hierbij dient aangetekend te worden dat de cijfers lastig te vergelijken zijn vanwege belangrijke verschillen tussen de groepen. De recidivecijfers tijdens en na forensische zorg zijn dus relatief gunstig, maar een delict kan enorme impact hebben en het zo veel mogelijk voorkomen van recidive blijft het ultieme doel van de behandeling in de forensische zorg. Het is nog onduidelijk wat precies bijdraagt aan recidivereductie en hoe behandeleffectiviteit of behandelsucces gedefinieerd kan worden.
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BACKGROUND: Higher levels of physical activity (PA) after treatment are associated with beneficial effects on physical and psychosocial functioning of cancer survivors. However, survivors often do not meet the recommended levels of PA. In order to promote PA, we developed a closed internet-based program. The aim of the study is to evaluate the (cost-)effectiveness of an internet-based PA-promotion program, alone or combined with physiotherapy counselling, compared to usual care, on PA-levels of breast or prostate cancer survivors. In this multicenter randomised controlled trial (RCT), breast or prostate cancer survivors who completed their primary treatment 3-12 months earlier, will be randomised to either 6-months access to a fully-automated internet-based intervention alone, an internet-based intervention plus remote support by a physiotherapist, or a control group. The intervention is based on the Transtheoretical Model and includes personalized feedback, information, video's and assignments. Additionally, in a second arm, physiotherapy counselling is provided through monthly scheduled and on-demand telephone calls. The control group will receive usual care and a leaflet with PA guidelines.METHODS: At baseline, 6 and 12 months, the primary outcome (PA) will be measured during 7 consecutive days by accelerometers. Secondary outcomes are self-reported PA, fatigue, mood, health-related quality of life, and costs. The group differences for primary and secondary outcomes will be analyzed using linear mixed models.DISCUSSION: If proven to be (cost)effective, this internet-based intervention, either alone or in combination with telephone support, will be a welcome addition to previous RCT's.TRIAL REGISTRATION: Netherlands trial register (NTR6911), Date of trial registration: December 21, 2017.
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Background/Objectives: Homecare staff often take over activities instead of “doing activities with” clients, thereby hampering clients from remaining active in daily life. Training and supporting staff to integrate reablement into their working practices may reduce clients' sedentary behavior and improve their independence. This study evaluated the effectiveness of the “Stay Active at Home” (SAaH) reablement training program for homecare staff on older homecare clients' sedentary behavior. Design: Cluster randomized controlled trial (c-RCT). Setting: Dutch homecare (10 nursing teams comprising a total of 313 staff members). Participants: 264 clients (aged ≥65 years). Intervention: SAaH seeks to equip staff with knowledge, attitude, and skills on reablement, and to provide social and organizational support to implement reablement in homecare practice. SAaH consists of program meetings, practical assignments, and weekly newsletters over a 9-month period. The control group received no additional training and delivered care as usual. Measurements: Sedentary behavior (primary outcome) was measured using tri-axial wrist-worn accelerometers. Secondary outcomes included daily functioning (GARS), physical functioning (SPPB), psychological functioning (PHQ-9), and falls. Data were collected at baseline and at 12 months; data on falls were also collected at 6 months. Intention-to-treat analyses using mixed-effects linear and logistic regression were performed. Results: We found no statistically significant differences between the study groups for sedentary time expressed as daily minutes (adjusted mean difference: β 18.5 (95% confidence interval [CI] 22.4, 59.3), p = 0.374) and as proportion of wake/wear time (β 0.6 [95% CI 1.5, 2.6], p = 0.589) or for most secondary outcomes. Conclusion: Our c-RCT showed no evidence for the effectiveness of SAaH for all client outcomes. Refining SAaH, by adding components that intervene directly on homecare clients, may optimize the program and require further research. Additional research should explore the effectiveness of SAaH on behavioral determinants of clients and staff and cost-effectiveness.
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Background: Adequate self-management skills are of great importance for patients with chronic obstructive pulmonary disease (COPD) to reduce the impact of COPD exacerbations. Using mobile health (mHealth) to support exacerbation-related self-management could be promising in engaging patients in their own health and changing health behaviors. However, there is limited knowledge on how to design mHealth interventions that are effective, meet the needs of end users, and are perceived as useful. By following an iterative user-centered design (UCD) process, an evidence-driven and usable mHealth intervention was developed to enhance exacerbation-related self-management in patients with COPD. Objective: This study aimed to describe in detail the full UCD and development process of an evidence-driven and usable mHealth intervention to enhance exacerbation-related self-management in patients with COPD. Methods: The UCD process consisted of four iterative phases: (1) background analysis and design conceptualization, (2) alpha usability testing, (3) iterative software development, and (4) field usability testing. Patients with COPD, health care providers, COPD experts, designers, software developers, and a behavioral scientist were involved throughout the design and development process. The intervention was developed using the behavior change wheel (BCW), a theoretically based approach for designing behavior change interventions, and logic modeling was used to map out the potential working mechanism of the intervention. Furthermore, the principles of design thinking were used for the creative design of the intervention. Qualitative and quantitative research methods were used throughout the design and development process. Results: The background analysis and design conceptualization phase resulted in final guiding principles for the intervention, a logic model to underpin the working mechanism of the intervention, and design requirements. Usability requirements were obtained from the usability testing phases. The iterative software development resulted in an evidence-driven and usable mHealth intervention—Copilot, a mobile app consisting of a symptom-monitoring module, and a personalized COPD action plan. Conclusions: By following a UCD process, an mHealth intervention was developed that meets the needs and preferences of patients with COPD, is likely to be used by patients with COPD, and has a high potential to be effective in reducing exacerbation impact. This extensive report of the intervention development process contributes to more transparency in the development of complex interventions in health care and can be used by researchers and designers as guidance for the development of future mHealth interventions.
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Abstract Background: Patients with glioma often suffer from cognitive deficits. Physical exercise has been effective in ameliorating cognitive deficits in older adults and neurological patients. This pilot randomized controlled trial (RCT) explored the possible impact of an exercise intervention, designed to improve cognitive functioning in glioma patients, regarding cognitive test performance and patient-reported outcomes (PROs). Methods: Thirty-four clinically stable patients with World Health Organization grades II/III glioma were randomized to a home-based remotely coached exercise group or an active control group. Patients exercised 3 times per week for 20-45 minutes, with moderate to vigorous intensity, during 6 months. At baseline and immediate follow-up, cognitive performance and PROs were assessed with neuropsychological tests and questionnaires, respectively. Linear regression analyses were used to estimate effect sizes of potential between-group differences in cognitive performance and PROs at 6 months. Results: The exercise group (n = 21) had small- to medium-sized better follow-up scores than the control group (n = 11) on several measures of attention and information processing speed, verbal memory, and executive function, whereas the control group showed a slightly better score on a measure of sustained selective attention. The exercise group also demonstrated small- to medium-sized better outcomes on measures of self-reported cognitive symptoms, fatigue, sleep, mood, and mental health-related quality of life. Conclusions: This small exploratory RCT in glioma patients provides a proof of concept with respect to improvement of cognitive functioning and PROs after aerobic exercise, and warrants larger exercise trials in brain tumor patients.
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Purpose: With the ageing population, there is an increasing demand for strategies to optimise muscle mass, strength and physical performance in community dwelling older adults. We designed a new innovative e-health intervention "VITAMIN" to improve physical performance in older adults. The blended home-based exercise intervention contains digital support to improve personalised coaching as well as dietary protein counselling. This study evaluates the 6 months effectiveness of the intervention. Methods: The cluster RCT included 245 community dwelling older adults (age = 55y) randomised to control, exercise, and exercise+dietary protein counselling group. Data was collected at baseline and after 6 months of intervention. The primary outcome was the modified Physical Performance test (mPPT) with an emphasis on daily functioning. Secondary measures were gait speed (GS; m/s), physical activity level (PAL), protein intake (g/kg/d), appendicular skeletal muscle mass by DXA (ASMM; kg), hand grip strength (HGS; kg). For statistical analysis SPSSv24.0 was used. A mixed models analysis was performed, with group, time and group*time interaction as fixed factors, subject and cluster as random factors, and additional posthoc Bonferroni test. Results: Mean age of the 224 evaluated participants was 72.0±smn;6.5y, 71% were females and 44% low educated. No significant intervention effect was found for mPPT (p=.889). Secondary outcomes showed a significant intervention effect: GS (p=.002), PAL (p=.014), protein intake (p<.001), ASSM (p=.029),HGS (p<.001). Posthoc Bonferroni showed that exercise+protein group had statistical improved outcome compared to control for these secondary outcomes (p<.001; p=.003; p<.001; p=.009; p<.001). Control group showed declined values at 6 months compared to baseline for GS (D-.23 m/s), PAL (D -.03), ASSM (D -.32 kg) and HGS (D -.96 kg).Conclusions: Older adults had already very high scores for physical performance (mPPT), however the blended home-based exercise intervention with protein counselling was still effective for gait speed, physical activity level, dietary protein intake, muscle mass and strength. This personalised innovative e-health intervention showed to be a promising strategy for community dwelling older adults for maintenance instead of declining physical function.
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OBJECTIVE: The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool was designed to classify randomized clinical trials (RCT) as being more pragmatic or explanatory. We modified the PRECIS tool (called PRECIS-Review tool [PR-tool]) to grade individual trials and systematic reviews of trials. This should help policy makers, clinicians, researchers, and guideline developers to judge the applicability of individual trials and systematic reviews. STUDY DESIGN AND SETTING: To illustrate the usefulness and applicability of the PR-tool, we applied it to two systematic reviews. Each included RCT was scored on the 10 PRECIS domains on a scale of 1-5. After this scoring, a 10-domain average for each individual trial and for the systematic review a single domain average and an overall average was calculated. RESULTS: One review was more pragmatic with an average score of 3.7 (range, 2.9-4.6) on our PR-tool, whereas the other review was more explanatory with an average score of 1.9 (range, 1.1-3.3). The results also suggest that the included studies within each systematic review were rather uniform in their approach, although some domains seemed more prone to heterogeneity. CONCLUSION: The PR-tool provides a useful estimate that gives insight by estimating quantitatively how pragmatic each RCT in the review is, which methodological domains are pragmatic or explanatory, and how pragmatic the review is.
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Hoofdstuk 1 in essaybundel Cameratoezicht en Design. Een bundel over camera’s als straatmeubilair. In de essays schrijven experts vanuit diverse invalshoeken over hun ervaringen en ideeën over de invloed van het ontwerp van camera’s. De bundel bevat de uitkomsten van een uitgebreid literatuuronderzoek en een concluderend hoofdstuk met daarin een schematische weergave van de diverse niveaus waarop design een rol speelt bij cameratoezicht.
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