What it takes to reduce sitting at work: a pilot study on the effectiveness and correlates of a multicomponent intervention.

OBJECTIVE: This study aimed to assess the feasibility and effects of a simple-to-implement multicomponent intervention to reduce sedentary time of office workers. METHODS: Six groups of eight to ten office workers took part in the two-week Leicht Bewegt intervention. Participants completed questionnaires at baseline (T0, n = 52), after 2 weeks (T1, n = 46), and after 5 weeks (T2, n = 38), including subjective sedentary measures and social-cognitive variables based on the health action process approach (HAPA). Objective sedentary measures were obtained using activPAL trackers. RESULTS: The intention to reduce sedentary behavior during work increased significantly from T0 to T1. Participants' objective and subjective sitting time decreased significantly from T0 to T1, corresponding to an average decrease per 8-h-workday of 55 min (d = - .66) or 74 min (d = - 1.14), respectively. This reduction persisted (for subjective sitting time) at T2 (d = - 1.08). Participants indicated a high satisfaction with the intervention. CONCLUSIONS: The Leicht Bewegt intervention offers a feasible and effective opportunity to reduce sedentary behavior at work. Randomized controlled trials including longer follow-up time periods are needed to validate its benefits in different workplaces.

Electrical dry needling versus a non-invasive multicomponent intervention in the treatment of myofascial trigger points in patients with chronic low back pain: A randomised clinical trial.

OBJECTIVE: To compare the effects of electrical dry needling with a non-invasive multi-component intervention in patients with chronic low back pain. DESIGN: A randomised single-blind clinical trial. SETTING: Outpatient Physiotherapy Clinic; home. PARTICIPANTS: Sixty-four patients with chronic low back pain aged 30-65 years. INTERVENTIONS: Six-week electrical dry needling on myofascial trigger points, and a non-invasive multicomponent intervention (home exercise programme, stretching and ischemic compression). MAIN MEASURES: Pain (Visual Analogue Scale), disability (Roland-Morris Disability Questionnaire and Oswestry Disability Index), kinesiophobia (Tampa Scale of Kinesiophobia), quality of life and sleep (Short Form 36-item Health Survey and Pittsburgh Sleep Quality Index), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion (finger-to-floor distance), and pressure pain threshold (algometer) were assessed at baseline, after 6 weeks, and after 2 months. RESULTS: ANOVA showed statistically significant differences in group-by-time interaction for most pain pressure thresholds of myofascial trigger points (P < 0.05), for disability (Roland-Morris Disability Questionnaire: F = 6.14, P = 0.016; and Oswestry Disability Index: F = 7.36, P = 0.009), for trunk anteflexion (F = 10.03, P = 0.002) and for habitual sleep efficacy (F = 6.65, P = 0.012), use of hypnotics (F = 4.77, P = 0.033) and total score of quality of sleep (F = 8.23, P = 0.006). CONCLUSIONS: In comparison to a non-invasive multicomponent intervention, electrical dry needling has more positive effects on disability, pain intensity, kinesiophobia, and reducing patients' sensitivity to myofascial trigger points pressure, at post-treatment and at 2 months. CLINICAL TRIAL REGISTRATION NUMBER: NCT04804228. Registered on May 28th, 2021. Available at https://clinicaltrials.gov/ct2/show/NCT04804228.

WEB OF TRANSFORMATIONS: impact of multicomponent intervention on the relationship between sociodemographic indicators, changes in body composition, cardiorespiratory fitness and biochemical markers in adolescents with overweight and obesity.

The study aims to analyze the relationships between changes after multicomponent intervention in sociodemographic indicators, body composition, cardiorespiratory fitness and biochemical markers in overweight/obese adolescents. Quasi-experimental study with 33 overweight/obese adolescents (17 in the intervention group (IG) and 16 in the control group (16)), in which the GI participated in the multicomponent intervention for 24 weeks. Sociodemographic indicators, body composition, cardiorespiratory fitness and biochemical markers were evaluated. Network analysis was performed using JASP software. In GI, the reduction in %BF proved to be the variable with greater connectivity and strength in the network compared to the control network. Changes in %BF were related to changes in ACR, BMI and leptin. It is concluded that the reduction in %BF is the most important variable in network relationships after the intervention, suggesting that the greater the reduction in %BF, the greater the effect on variables such as BMI, ACR and leptina.

The PRO-HOME Project. A multicomponent intervention for the protected discharge from the hospital of multimorbid and polytreated older individuals by using innovative technologies: A pilot study.

BACKGROUD: Discharge planning from the hospital of frail older patients is an important step to avoid inappropriate long-stay hospitalizations and to prevent the risks related to the prolonged hospitalization. In this frame, we developed an experimental trial-'PRO-HOME', a multicomponent programme of interventions for multimorbid and polytreated hospitalized older patients. AIM: The main aim of the study was to develop a protected discharge facility using a mini apartment equipped with advanced architectural and technological components to reduce the length of hospital stay of older participants (aged 65+ years old) admitted to the hospital for an acute event, deemed stable and dischargeable. MATERIALS AND METHODS: This is a pilot randomized controlled study, comparing 30 hospitalized participants included in a multidimensional, transitional care programme based on information and communication technologies to 30 patients in standard usual care until hospital discharge. RESULTS: We presented the study design of the PRO-HOME programme, including architectural and technological components, the enrolment procedures, the components of the intervention that is physical activity, cognitive training and life-style education and the evaluation method of the intervention based on the Comprehensive Geriatric Assessment to explore the changes in the individual domains that are target of the multicomponent intervention. CONCLUSIONS: The final results will suggest whether the PRO-HOME programme represents a useful and feasible intervention to reduce the length of hospital stay of multimorbid and polytreated hospitalized older patients and improve their physical and cognitive performances and overall quality of life. PATIENT OR PUBLIC CONTRIBUTION: Due to the characteristics of the population of interest of the PRO-HOME study, we involved in the study design and programme of the activities the participants enrolled in a previous smart home-based project named MoDiPro carried-out during a 3-year period. The elderly participants from the local population involved were asked, by means of focus groups, for feedback on their experience in MoDiPro, and their suggestions were integrated into the design phase of the current PRO-HOME project. The focus groups included open group interviews with a qualitative collection of the patients' feedback so that the participants could interact with each other.

Effects of a multicomponent intervention on cardiovascular risk factors in overweight children: a randomized clinical trial in light of complex systems.

Analyzing the effects of interventions from a theoretical and statistical perspective that allows understanding these dynamic relationships of obesity etiology can be a more efficient and innovative way of understanding the phenomenon's complexity. Thus, we aimed to analyze the pattern of cardiovascular risk factors between-participants, and the effects within-participants of a multidisciplinary intervention on cardiovascular risk factors in overweight children. This is a randomized clinical trial, and 41 participated in this study. A multicomponent intervention (physical activities, nutritional and psychological counseling) was performed for 10 weeks. Anthropometric and hemodynamics measurements, lipid and glucose profile, cardiorespiratory fitness, and left ventricular mass were evaluated. A network analysis was done. Considering patterns in the network at baseline, WC, WHR, BMI, and Fat were the main variables for cardiovascular risks. Group was the most critical variable in the within-participant network. Participating in a multicomponent intervention and decreasing body fat promoted beneficial cardiovascular factors.

Adherence of older people to a multidimensional program to improve health-related quality of life and functional capacity.

BACKGROUND: The adherence of the elderly to therapeutic programs, either they are pharmacological or psychosocial, is generally low. OBJECTIVE: Identifying predictive variables of adherence of a social program from elderly with multifunctional independence or mild dependence. METHOD: Prospective longitudinal design with 104 elderly participants in a social program. The inclusion criteria were: to participate in a social program for elderly, present functional independence or mild dependence, without depression clinically confirmed. Descriptive analyzes were performed with the study variables in addition to hypothesis testing and linear and logistic regression models to identify predictive variables of adherence. RESULTS: 22% of the participants met the minimum adherence, observing better compliance in younger people (p = 0.004), among those who had a better Health-Related Quality of Life (p = 0.036) and better health literacy levels (p = 0.017). According to a linear regression model, the variables associated with adherence were: social program of origin (OR = 5,122), perception of social support (OR = 1,170), cognitive status (OR = 2,537). CONCLUSION: The level of adherence of the older people of the study can be evaluated as low, which is consistent with the findings of the specialized literature. The variables identified with predictive capacity on adherence were social program of origin, a condition that can be incorporated into the design of the interventions in order to facilitate territorial equity. It is also important to highlight the importance of health literacy and the risk of dysphagia in the level of adherence.

The impact of medication reviews by general practitioners on psychotropic drug use and behavioral and psychological symptoms in home-dwelling people with dementia: results from the multicomponent cluster randomized controlled LIVE@Home.Path trial.

BACKGROUND: There is limited knowledge regarding the process of deprescribing psychotropic drugs to people with dementia (PwD) conducted by general practitioners (GP). We investigated the impact of a multicomponent intervention, emphasizing medication reviews, on psychotropic drugs and behavioral and psychological symptoms (BPSD) in home-dwelling PwD and quantified change in patient-GP communication evaluated by their informal caregivers. METHODS: LIVE@Home.Path is a stepped-wedge closed-cohort cluster randomized controlled trial for people with mild to moderate dementia aged ≥65 and their informal caregivers (dyads) in Norway. Complementary to health care as usual (control condition), municipal coordinators implemented the multicomponent LIVE intervention: Learning, Innovation, Volunteer support, and Empowerment (including medication review by the PwD's regular GPs). Block-randomization was used to allocate dyads in three groups receiving the intervention sequentially in periods of 6 months duration. Prepandemic data from the first period is reported, resulting in a 1:2 intervention-to-control ratio. Primary outcome was change in psychotropic drug use. Secondary outcomes were changes in BPSD by Neuropsychiatric Inventory and Cornell Scale of Depression in Dementia and patient-GP communication by an adaption of the Clinical Global Impression of Change. RESULTS: Four hundred thirty-eight dyads were screened, 280 included, and 237 participated at 6 months (intervention group n=67; control condition n=170). At baseline, 63% used psychotropic medication regularly: antidementia drugs (47%), antidepressants (13%), hypnotics/sedatives (13%), antipsychotics (5%), and anxiolytics (2%). At 6 months, medication reviews were more frequently conducted in the intervention group compared to control (66% vs 42%, P=0.001). We found no differences regarding a change in drug use and BPSD. Patient-GP communication enhanced in the intervention group (mean score 0.95 [standard deviation 1.68] vs 0.41 [1.34], P=0.022). In the intervention group, control group, and overall sample, the informal caregivers of those who had their medications reviewed reported improved patient-GP communication compared to those who did not. CONCLUSIONS: Change in psychotropic drug use and BPSD did not differ, even though patient-GP communication improved with medication reviews. Restricted psychotropic drug use among PwD likely reflects more judicious prescribing practices in recent years. Nevertheless, medication reviews could be cultivated to optimize pharmacologic treatment for this complex population. TRIAL REGISTRATION: ClinicalTrials.gov : NCT04043364 ; registered 15/03/2019.

Freedom as Prevention: Mechanisms of Autonomy Support for Promoting HIV Pre-Exposure Prophylaxis Use and Condom Use among Black MSM in 3 US Cities-HPTN 073.

Healthcare providers who use controlling or coercive strategies may compel short-term enactment of HIV and sexually transmitted infection prevention behaviors but may inadvertently undermine their client's motivation to maintain those behaviors in the absence of external pressure. Autonomous motivation refers to the self-emanating and self-determined drive for engaging in health behaviors. It is associated with long-term maintenance of health behaviors. We used structural equation modeling to investigate whether autonomy support was associated with increased odds of therapeutic serum levels of pre-exposure prophylaxis, through a pathway that satisfies basic psychological needs for autonomous self-regulation and competence regarding pre-exposure prophylaxis use. We also investigated whether autonomy support was associated with decreased odds of condomless anal intercourse via the same psychological needs-satisfaction pathway of autonomous self-regulation and competence regarding condom use. We tested these two theorized pathways using secondary data from a longitudinal sample of Black men who have sex with men from across three cities in the US (N = 226). Data from the sample fit the theorized models regarding the pathways by which autonomy support leads to the presence of therapeutic PrEP levels in serum (χ2 = 0.56; RMSEA = 0.04; CFI = .99, TLI = 0.98) and how it also leads to decreased odds of condomless anal intercourse (χ2 = 0.58; RMSEA = 0.03; CFI = 0.99; TLI = 0.98). These findings provide scientific evidence for the utility of self-determination theory as a model to guide intervention approaches to optimize the implementation and impact of PrEP for Black men who have sex with men.

Building a country-wide Fistula Treatment Network in Kenya: results from the first six years (2014-2020).

It is estimated that one million women worldwide live with untreated fistula, a devastating injury primarily caused by prolonged obstructed labor when women do not have access to timely emergency obstetric care. Women with fistula are incontinent of urine and/or feces and often suffer severe social and psychological consequences, such as profound stigma and depression. Obstetric fistula affects economically vulnerable women and garners little attention on the global health stage. Exact figures on fistula incidence and prevalence are not known. In Kenya, results from a 2014 population-based survey suggest that 1% of reproductive-aged women have experienced fistula-like symptoms. In collaboration with key stakeholders, Fistula Foundation launched the Fistula Treatment Network (initially known as Action on Fistula) in 2014 to increase access to timely, quality fistula treatment and comprehensive post-operative care for women with fistula in Kenya. The integrated model built linkages between the community and the health system to support women through all parts of their treatment journey and to build capacity of healthcare providers and community leaders who care for these women. Fistula Foundation and its donors provided the program's funding. Seed funding, representing about 30% of the program budget, was provided by Astellas Pharma EMEA.Over the six-year period from 2014 to 2020, the network supported 6,223 surgeries at seven hospitals, established a fistula training center, trained eleven surgeons and 424 Community Health Volunteers, conducted extensive community outreach, and contributed to the National Strategic Framework to End Female Genital Fistula. At 12 months post fistula repair, 96% of women in a community setting reported that they were not experiencing any incontinence and the proportion of women reporting normal functioning increased from 18% at baseline to 85% at twelve-months.The Fistula Treatment Network facilitated collaboration across hospital and community actors to enhance long-term outcomes for women living with fistula. This model improved awareness and reduced stigma, increased access to surgery, strengthened the fistula workforce, and facilitated post-operative follow-up and reintegration support for women. This integrated approach is an effective and replicable model for building capacity to deliver comprehensive fistula care services in other countries where the burden of fistula is high.

A 6-week healthy eating intervention with family engagement improves food knowledge and preferences but not dietary diversity among urban preschool children in Sri Lanka.

OBJECTIVE: To evaluate the effectiveness of a multicomponent intervention (MCI) on children's dietary diversity and its impact pathway components of children's food knowledge and healthy food preferences. DESIGN: A 6-week cluster randomised controlled trial with a MCI consisting of child nutrition education plus family engagement through parental nutrition education, meal preparation and tasting was compared with two groups: single component intervention (SCI) of child nutrition education, and control, conducted during February to July 2018. Preschool centres were randomly assigned to one of the three arms. Children's food knowledge, healthy food preferences and dietary diversity scores were collected. Intervention effects were analysed using a pre-post analysis and a difference-in-difference model. SETTING: Fourteen preschool centres in an urban area of Kurunegala, Sri Lanka. PARTICIPANTS: Child-parent dyads of children aged 4-6 years. Final analyses included 306 (for food knowledge and preferences) and 258 (for dietary diversity) dyads. RESULTS: MCI significantly influenced the impact pathways to children's dietary diversity by increasing children's food knowledge and healthy food preferences scores by 3·76 and 2·79 (P < 0·001), respectively, but not the dietary diversity score (P = 0·603), compared with the control arm. Relative to SCI, MCI significantly improved children's food knowledge score by 1·10 (P < 0·001), but no significant effects were noted for other outcome variables. CONCLUSIONS: Improved food knowledge and preferences require a positive food environment and time to develop into healthy eating behaviours. Research into dietary diversity should broaden to incorporate the contextual roles of the home and general food environments to more completely understand food choices of children.

The PREvention Program for Alzheimer's RElated Delirium (PREPARED) cluster randomized trial: a study protocol.

BACKGROUND: Delirium is a significant cause of morbidity and mortality among older people admitted to both acute and long-term care facilities (LTCFs). Multicomponent interventions have been shown to reduce delirium incidence in the acute care setting (30-73%) by acting on modifiable risk factors. Little work, however, has focused on using this approach to reduce delirium incidence in LTCFs. METHODS: The objective is to assess the effectiveness of the multicomponent PREPARED Trial intervention in reducing the following primary outcomes: incidence, severity, duration, and frequency of delirium episodes in cognitively impaired residents. This 4-year, parallel-design, cluster randomized study will involve nursing staff and residents in 45-50 LTCFs in Montreal, Canada. Participating public and private LTCFs (clusters) that provide 24-h nursing care will be assigned to either the PREPARED Trial intervention or the control (usual care) arm of the study using a covariate constrained randomization procedure. Approximately 400-600 LTC residents aged 65 and older with dementia and/or cognitive impairment will be enrolled in the study and followed for 18 weeks. Residents must be at risk of delirium, delirium-free at baseline and have resided at the facility for at least 2 weeks. Residents who are unable to communicate verbally, have a history of specific psychiatric conditions, or are receiving end-of-life care will be excluded. The PREPARED Trial intervention consists of four main components: a decision tree, an instruction manual, a training package, and a toolkit. Primary study outcomes will be assessed weekly. Functional autonomy and cognitive levels will be assessed at the beginning and end of follow-up, while information pertaining to modifiable delirium risk factors, medical consultations, and facility transfers will be collected retrospectively for the duration of the follow-up period. Primary outcomes will be reported at the level of intervention assignment. All researchers analyzing the data will be blinded to group allocation. DISCUSSION: This large-scale intervention study will contribute significantly to the development of evidence-based clinical guidelines for delirium prevention in this frail elderly population, as it will be the first to evaluate the efficacy of a multicomponent delirium prevention program translated into LTC clinical practice on a large scale. TRIAL REGISTRATION: NCT03718156 , ClinicalTrials.gov .

Development of a salutogenic intervention for healthy eating among Dutch type 2 diabetes mellitus patients.

Healthy eating can be challenging for type 2 diabetes mellitus (T2DM) patients. The theory of salutogenesis, which focuses on the resources required to organize behavioural changes in everyday life, was used to develop an intervention for healthy eating. The aim was to describe the development, structure and content of this salutogenic intervention. The development consisted of two phases that were based on the operationalization of important key principles of salutogenesis. In Phase 1 (Exploration and synthesis), a systematic review and three qualitative studies were performed to explore important characteristics to enable healthy eating in everyday life. The results were used to develop the draft intervention. In Phase 2 (Validation and adjustment), interviews and workshops were conducted with T2DM patients, healthcare providers and scientists. Based on this, the draft intervention was modified into its final form. The developmental process resulted in a 12-week, group-based intervention that aimed to enable important resources for healthy eating via self-examination, reflection, setting goals and sharing experiences. Attention was also paid to disease information, disease acceptance, food literacy, stress management, self-identity and social support. The group sessions began following an individual intake session, with a booster session held 3 months after the intervention. The researcher's translation of the stakeholders' priorities into an intervention was corrected for and approved by the stakeholders concerned. This comprehensive salutogenic intervention was developed based on practical and scientific evidence. Providing transparency in developmental processes and content is important because it determines the scientific integrity and credibility of an intervention.

Healthy eating can be difficult for people with the disease type 2 diabetes. This article describes how a programme aimed at helping type 2 diabetes patients to eat healthily was developed. The draft version of the programme was based on a theoretical framework that aims to understand what creates health in everyday life, and on conversations with type 2 diabetes patients and healthcare providers. The draft programme was adjusted based on the feedback of type 2 diabetes patients, healthcare providers and scientists. This resulted in a 12-week, group-based programme that enables people to think about who they are and what they want by setting health goals and sharing experiences. Attention was also paid to disease knowledge, disease acceptance, nutritional skills, dealing with stress, self-identity and social support. The group sessions began following an individual intake session, with a booster session held 3 months after the intervention. By involving everybody, we were able to develop a programme that takes into account the preferences, needs and priorities of all stakeholders. It is important to describe the development and the content of programmes encouraging healthy eating to determine their quality and effectivity.

Do Combinations of Behavior Change Techniques That Occur Frequently in Interventions Reflect Underlying Theory?

BACKGROUND: Behavioral interventions typically include multiple behavior change techniques (BCTs). The theory informing the selection of BCTs for an intervention may be stated explicitly or remain unreported, thus impeding the identification of links between theory and behavior change outcomes. PURPOSE: This study aimed to identify groups of BCTs commonly occurring together in behavior change interventions and examine whether behavior change theories underlying these groups could be identified. METHODS: The study involved three phases: (a) a factor analysis to identify groups of co-occurring BCTs from 277 behavior change intervention reports; (b) examining expert consensus (n = 25) about links between BCT groups and behavioral theories; (c) a comparison of the expert-linked theories with theories explicitly mentioned by authors of the 277 intervention reports. RESULTS: Five groups of co-occurring BCTs (range: 3-13 BCTs per group) were identified through factor analysis. Experts agreed on five links (≥80% of experts), comprising three BCT groups and five behavior change theories. Four of the five BCT group-theory links agreed by experts were also stated by study authors in intervention reports using similar groups of BCTs. CONCLUSIONS: It is possible to identify groups of BCTs frequently used together in interventions. Experts made shared inferences about behavior change theory underlying these BCT groups, suggesting that it may be possible to propose a theoretical basis for interventions where authors do not explicitly put forward a theory. These results advance our understanding of theory use in multicomponent interventions and build the evidence base for further understanding theory-based intervention development and evaluation.

The physical activity at work (PAW) study protocol: a cluster randomised trial of a multicomponent short-break intervention to reduce sitting time and increase physical activity among office workers in Thailand.

BACKGROUND: High levels of sedentary behaviour (SB) are associated with non-communicable diseases. In 2016, the estimated total healthcare expenditure from physical activity (PA) in Thailand added up to $190 million in international dollars. The challenge to reduce SB and increase PA among office workers is more urgent now than ever as Thailand is transforming itself from a predominantly rural country to an increasingly urban one. This study will investigate the effectiveness of a multicomponent short break intervention on the reduction of SB during office hours. METHODS/DESIGN: This two-armed Physical Activity at Work (PAW) cluster randomised controlled trial will recruit 360 office workers from 18 offices in the Thailand's Ministry of Public Health (MOPH). Offices will be randomised to either the intervention group or the control group. The multicomponent intervention is informed by the Social Ecological Model and Behaviour Change Techniques (BCTs) and contains four components: (i) organisational, including heads of the participating divisions leading exercises, sending encouragement text messages and acknowledging efforts; (ii) social, including team movement breaks and team-based incentives; (iii) environmental, including posters to encourage exercise; and (iv) individual components including real-time PA feedback via an individual device. The main intervention component will be a short break intervention. The primary outcome of this study is the sedentary time of office workers. Secondary outcomes include time spent on PA, cardiometabolic outcomes, work productivity, musculoskeletal pain, and quality of life. The study also includes process and economic evaluations from the individual and societal perspective. DISCUSSION: The study will be the first experimental study in Thailand to investigate the effect of a short-break intervention at the workplace on SBs of office workers and health outcomes. The study will also include a cost-effectiveness analysis to inform investments on short break interventions under the Universal Healthcare Coverage in Thailand, which includes health promotion and disease prevention component. TRIAL REGISTRATION: The PAW study has been registered at the Thai Clinical Trials Registry (TCTR) under the study ID TCTR20200604007 . Registered 02 June 2020,.

Reducing falls through the implementation of a multicomponent intervention on a rural mixed rehabilitation ward.

PROBLEM: There is an absence of literature to guide staff in how falls can be reduced in a diverse patient population on a mixed acute/subacute rehabilitation unit, especially one with daily fluctuations in acuity that occurs due to frequent changes in its acute/rehabilitation patient ratio. DESIGN: Pre-intervention and post-intervention audits. SETTING: The Rehabilitation Unit at Tamworth Rural Referral Hospital in Tamworth, NSW. KEY MEASURES FOR IMPROVEMENT: Improvement in the number of falls and repeat fallers. STRATEGIES FOR CHANGE: A multicomponent intervention involving: (a) in-service education sessions for nursing staff about falls risk-increasing drugs, (b) patient and family education regarding falls risks and prevention strategies, (c) improving documentation of incident reports by using a set template, (d) ensuring that the correct patient mobility status information is handed over between nursing shifts and physiotherapists providing timely and regular updates, (e) the introduction of the 'traffic light mobility system' and (f) enhancing the use of existing falls prevention strategies. EFFECTS OF CHANGE: The total falls reduced in number from 36 falls to 19 with a decrease in the number of repeat fallers from 8 to 4. There was also increased compliance with existing falls risk tools and improved documentation of each falls incident which provided insight into activities and times with higher falls risk. LESSONS LEARNT: A multicomponent approach remained effective even when applied to a mixed acute/subacute rehabilitation ward setting.

Effectiveness of individual and group multicomponent interventions for smoking cessation in primary care: a quasi-experimental study.

BACKGROUND: The efficacy of smoking cessation interventions can be quite diverse in day-to-day clinical practice. OBJECTIVE: To analyse the effectiveness in smoking cessation of multicomponent interventions carried out in groups or individually in primary care practices. METHODS: A quasi-experimental, multicentre study of 12-month follow-up of patients treated in multicomponent smoking cessation interventions was carried out in Urban health care centres in Sevilla, Spain. Two hundred and twenty smoking patients, ≥18 years of age, participated either in a multicomponent intervention group (n = 145; mean age 51.7 years; 53.1% women) or in individual interventions (n = 77; mean age 50.5 years; 61.0% women). The abstinence or relapse status was computed from patient self-reports, confirmed by relatives or companions when possible and supplemented by CO-oxymetry tests in 89 patients. RESULTS: The overall percentage of smoking cessation was 36.9% (37.9% with group and 35.1% with individual intervention, P = 0.398). Patients who quit smoking were younger (48.7 versus 52.9 years old, P < 0.01), with fewer years of smoking (32.9 versus 36.8 years, P < 0.05), with higher education (39.0% versus 25.0%, P < 0.05) and had received pharmacological treatment (91.5% versus 67.9%, P < 0.001). In the multivariate analysis, level of education [odds ratio (OR): 1.995; 95% confidence interval (CI): 1.065-3.735, P < 0.01], group intervention (OR: 1.743; 95% CI: 1.006-3.287, P < 0.05) and drug prescription (OR: 2.368; 95% CI: 1.126-4.980, P < 0.05) were significantly associated with smoking cessation. CONCLUSIONS: Our study found that multicomponent group and individual interventions in primary care were associated with an overall quit rate of smoking of 36.9% at 12-month follow-up, with higher probability of success among patients with higher education and those who received the group intervention and drug treatment.

Effectiveness and cost-effectiveness of a multicomponent intervention to implement a clinical practice guideline for systemic lupus erythematosus: protocol for a cluster-randomized controlled trial.

BACKGROUND: Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE). METHODS: The study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned. DISCUSSION: Impact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting. TRIAL REGISTRATION: ClinicalTrial.gov NCT03537638 . Registered on 25 May 2018.

Effectiveness of a multicomponent self-management intervention for adults with epilepsy (ZMILE study): A randomized controlled trial.

BACKGROUND: The objective of the ZMILE study was to compare the effectiveness of a multicomponent self-management intervention (MCI) with care as usual (CAU) in adult patients with epilepsy (PWE) over a six-month period. METHODS: Participants (PWE & relative) were randomized into intervention or CAU groups. Self-report questionnaires were used to measure disease-specific self-efficacy as the primary outcome measure and general self-efficacy, adherence, seizure severity, emotional functioning, quality of life, proactive coping, and side-effects of antiepileptic drugs (AED) as secondary outcome measures. Instruments used at baseline and during a six-month follow-up period were the following: disease-specific self-efficacy (Epilepsy Self-Efficacy Scale [ESES], General Self-Efficacy Scale [GSES]); adherence (Medication Adherence Scale [MARS] and Medication Event Monitoring System [MEMS]); seizure severity (National Hospital Seizure Severity Scale [NHS3]); emotional well-being (Hospital Anxiety and Depression Scale [HADS]); quality of life (Quality of Life in Epilepsy [QOLIE-31P]); proactive coping (Utrecht Proactive Coping Competence [UPCC]); and side-effects of antiepileptic drugs [SIDAED]. Multilevel analyses were performed, and baseline differences were corrected by inclusion of covariates in the analyses. RESULTS: In total, 102 PWE were included in the study, 52 of whom were in the intervention group. On the SIDAED and on three of the quality of life subscales QOLIE-31P, a significant difference was found (p<0.05) in the intervention group. Self-efficacy, however, showed no significant differences between the MCI and the CAU groups. None of the other outcome measures showed any significant difference between the two groups. SIGNIFICANCE: Although we found no statistically significant difference in the primary outcome measure, disease-specific self-efficacy, this MCI could prove promising, since we found improvement in some domains of quality of life in epilepsy scale and a decrease in AED side-effects in the MCI group compared with the CAU group.

The BeHealthyR Study: a randomized trial of a multicomponent intervention to reduce stress, smoking and improve financial health of low-income residents in Rotterdam.

BACKGROUND: Compared to higher socioeconomic status (SES) groups, those in lower SES groups are financially strained, experience higher rates of smoking-related morbidity, are in poorer health and have reduced life expectancy. This is especially true for the city of Rotterdam, where a large inequality in health is observed between low and high SES groups. The BeHealthyR study (Dutch: Grip en Gezondheid) is a randomized controlled trial (RCT) which will evaluate the impact of a theory-based multicomponent behavior intervention aiming to reduce stress, smoking, and improve financial health by means of a group-based stress management program combining cognitive and behavioral techniques, and nudges in low-SES residents living in Rotterdam. METHODS: The BeHealthyR study is a three-arm RCT. Between February 2018 and July 2019, low-SES participants who perceive stress, smoke, are financially strained and reside in Rotterdam (one of the four largest cities in The Netherlands) are recruited. Subsequently, participants are randomly assigned to either a stress management condition (SM), stress management with a buddy condition (SM-B) or a control condition (CC). Participants in the SM and SM-B conditions will attend four weekly group sessions (1.5 h/session) and a follow-up session eight weeks later. The SM condition includes psychoeducation and exercises, and cognitive and behavioral intervention techniques. Demographic data and objective measures will be collected at baseline (T0), four weeks post-baseline (T1), and twelve weeks post-baseline (T2). Primary outcome measures are to reduce stress, smoking and improve financial health. We hypothesize that low-SES participants in the intervention conditions, compared with those in the control condition, will experience less stress, smoke less and have improved financial health. DISCUSSION: This study is a group-based intervention which aims to investigate the effects of a theory-based behavioral change intervention employing several components on reducing stress, smoking, and improving financial health in low-SES residents living in Rotterdam. If effective, the findings from the present study will serve to inform future directions of research and clinical practice with regard to behavioral change interventions for low-SES groups. TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT03553979 ). Registered on January 1 2018.

Randomized controlled trial on the effectiveness of a multicomponent intervention on migraine: A study protocol.

AIM: To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. BACKGROUND: Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). DESIGN: The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. METHODS: The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. DISCUSSION: Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. TRIAL REGISTRATION: The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in, ). CTRI reference ID: CTRI/2015/10/006282.