scholarly journals Implementation, mechanisms of impact and key contextual factors involved in outcomes of the Modification of Diet, Exercise and Lifestyle (MODEL) randomised controlled trial in Australian adults: protocol for a mixed-method process evaluation

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e036395
Author(s):  
Reindolf Anokye ◽  
Simone Radavelli-Bagatini ◽  
Catherine P Bondonno ◽  
Marc Sim ◽  
Lauren C Blekkenhorst ◽  
...  
Keyword(s):  
Process Evaluation ◽  
Mixed Method ◽  
Controlled Trial ◽  
Behavioural Change ◽  
Implementation Strategies ◽  
Pictorial Representation ◽  
Model Study ◽  
Study Results ◽  
Qualitative Component ◽  
The Impact

IntroductionThe Modification of Diet, Exercise and Lifestyle (MODEL) study aims to examine the impact of providing visualisation and pictorial representation of advanced structural vascular disease (abdominal aortic calcification), on ‘healthful’ improvements to diet and lifestyle. This paper reports the protocol for the process evaluation for the MODEL study.Methods and analysisThe overall aim of the process evaluation is to understand the processes that took place during participation in the MODEL study trial and which elements were effective or ineffective for influencing ‘healthful’ behavioural change, and possible ways of improvement to inform wider implementation strategies. A mixed-method approach will be employed with the use of structured questionnaires and semistructured in-depth interviews. All 200 participants enrolled in the trial will undertake the quantitative component of the study and maximum variation sampling will be used to select a subsample for the qualitative component. The sample size for the qualitative component will be determined based on analytical saturation. Interviews will be digitally recorded and transcribed verbatim. Qualitative data will be analysed thematically and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.Ethics and disseminationThe MODEL study process evaluation has received approval from Edith Cowan University Human Research Ethics Committee (Project Number: 20513 HODGSON). Written informed consent will be obtained from all participants before they are included in the study. The study results will be shared with the individuals and institutions associated with this study as well as academic audiences through peer-reviewed publication and probable presentation at conferences.Trial registration numberACTRN12618001087246.

scholarly journals A cluster RCT and process evaluation evaluating the effectiveness of an optimisation intervention to promote parental engagement in a childhood obesity prevention programme: Results of the Optimising Family Engagement in HENRY (OFTEN) trial

2021 ◽  
Author(s):  
Maria Bryant ◽  
Wendy Burton ◽  
Michelle Collinson ◽  
Amanda Farrin ◽  
Jane Nixon ◽  
...  
Keyword(s):  
Childhood Obesity ◽  
Process Evaluation ◽  
Obesity Prevention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Parental Engagement ◽  
Childhood Obesity Prevention ◽  
Prevention Intervention ◽  
The Impact ◽  
Children’S Centres

Abstract Background Low parental participation reduces the impact and sustainability of public health childhood obesity prevention programmes. Using data from a focused ethnography, we developed a multi-level, theory-based implementation optimisation intervention. The optimisation intervention aimed to support local authorities and children’s centres to adopt behaviours to promote engagement in ‘HENRY (Health Exercise Nutrition for the Really Young)’, a UK community obesity prevention intervention. Methods We evaluated the effectiveness of the optimisation intervention on programme enrolment and completion over a 12 implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children’s centres) to HENRY plus the optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interview data and routine monitoring to explain trial results. Results Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference -1.2%; 95%CI: -19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95%CI: -15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced implementation of both HENRY and the optimisation intervention due to competing demands. Thus, at follow up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n=433 vs. 881). Conclusions During a period in which services were reduced by policies outside the realm of this research, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent engagement in an obesity prevention intervention. Trial registration: ClinicalTrials.gov Identifier: NCT02675699 registered 4th February 2016. https://clinicaltrials.gov/ct2/show/NCT02675699

scholarly journals Why do general practitioners not refer patients to behaviour-change programmes after preventive health checks? A mixed-method study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Nina Kamstrup-Larsen ◽  
Marie Broholm-Jørgensen ◽  
Susanne O. Dalton ◽  
Lars B. Larsen ◽  
Janus L. Thomsen ◽  
...  
Keyword(s):  
General Practitioners ◽  
Behaviour Change ◽  
Mixed Method ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Behavioural Change ◽  
Preventive Health ◽  
Health Checks ◽  
Randomised Controlled ◽  
The Right

Abstract Background This study was embedded in the Check-In randomised controlled trial that investigated the effectiveness of general practice-based preventive health checks on adverse health behaviour and early detection of non-communicable diseases offered to individuals with low socioeconomic positions. Despite successful recruitment of patients, the intervention had no effect. One reason for the lack of effectiveness could be low rates of referral to behaviour-change programmes in the municipality, resulting in a low dose of the intervention delivered. The aim of this study is to examine the referral pattern of the general practitioners and potential barriers to referring eligible patients to these behaviour-change programmes. Methods A mixed-method design was used, including patients’ questionnaires, recording sheet from the health checks and semi-structured qualitative interviews with general practitioners. All data used in the study were collected during the time of the intervention. Logistic regressions were used to estimate odds ratios for being eligible and for receiving referrals. The qualitative empirical material was analysed thematically. Emerging themes were grouped, discussed and the material was re-read. The themes were reviewed alongside the analysis of the quantitative material to refine and discuss the themes. Results Of the 364 patients, who attended the health check, 165 (45%) were marked as eligible for a referral to behaviour-change programme by their general practitioner and of these, 90 (55%) received referrals. Daily smoking (OR = 3.22; 95% CI:2.01–5.17), high-risk alcohol consumption (OR = 2.66; 95% CI:1.38–5.12), obesity (OR = 2.89; 95% CI:1.61–5.16) and poor lung function (OR = 2.05; 95% CI:1.14–3.70) were all significantly associated with being eligible, but not with receiving referral. Four themes emerged as the main barriers to referring patients to behaviour-change programmes: 1) general practitioners’ responsibility and ownership for their patients, 2) balancing information and accepting a rejection, 3) assessment of the right time for behavioural change and 4) general practitioners’ attitudes towards behaviour-change programmes in the municipality. Conclusion We identified important barriers among the general practitioners which influenced whether the patients received referrals to behaviour-change programmes in the municipality and thereby influenced the dose of intervention delivered in Check-In. The findings suggest that an effort is needed to assist the collaboration between general practices and the municipalities’ primary preventive services. Trial registration Clinical Trials NCT01979107; October 25, 2013.

scholarly journals Impact of a demand-side integrated WASH and nutrition community-based care group intervention on behavioural change: a randomised controlled trial in western Kenya

2020 ◽  
Vol 5 (11) ◽  
pp. e002806
Author(s):  
Matthew C Freeman ◽  
Anna S Ellis ◽  
Emily Awino Ogutu ◽  
Bethany A Caruso ◽  
Molly Linabarger ◽  
...  
Keyword(s):  
Low Income ◽  
Controlled Trial ◽  
Behavioural Change ◽  
Randomised Trial ◽  
Nutrition Intervention ◽  
Double Difference ◽  
Cluster Randomised Trial ◽  
Care Group ◽  
Western Kenya ◽  
The Impact

IntroductionGrowth shortfalls and diarrhoeal diseases remain a major cause of morbidity and mortality in low-income settings. Due to the multifaceted causes of undernutrition and the identified limitations of siloed nutrition programmes, improving the delivery of integrated water, sanitation, hygiene (WASH) and nutrition programming could improve child health.MethodsWe conducted a cluster randomised trial in western Kenya to assess the impact on household behaviours of a novel, theory-informed and integrated WASH and nutrition intervention delivered through care groups as compared with the standard care group approach. We developed an intervention targeting practices relating to food hygiene, mealtime and feeding, and compound cleanliness, each using various behavioural change techniques to influence the uptake of targeted behaviours. Prespecified behavioural outcomes were verified through direct observation, 24 hours recall, and self-reported picture-based methods.ResultsCompared with control households, a greater proportion of intervention households had a hygienic food preparation area (Risk double difference (RDD) 0.81, 95% CI 0.68 to 0.96), had stored food hygienically (RDD 0.76, 95% CI 0.58 to 1.00), had a functional handwashing station (RDD 0.64, 95% CI 0.56 to 0.74), provided a safe space for their child to play (RDD 0.73, 95% CI 0.56 to 0.96), and who fed their children thickened porridge (RDD 0.56, 95% CI 0.51 to 0.63) at endline. The proportion of children 6–24 months in intervention households consuming a sufficient diversity of foods (RDD 0.81, 95% CI 0.64 to 1.04) was higher than in control households; however, there was a non-significant increase in the percentage of pregnant and lactating women receiving an adequate diversity of foods in their diets (RDD 0.86, 95% CI 0.70 to 1.05) among intervention compared with control households at endline.ConclusionOur integrated WASH and nutrition intervention resulted in important changes in behaviours. This theory-informed intervention could be added to existing care group programmes to considerable advantage.

scholarly journals KAJIAN KERENTANAN MASYARAKAT TERHADAP PERUBAHAN IKLIM BERBASIS DAERAH ALIRAN SUNGAI (STUDI KASUS SUB DAS GARANG HULU)

2012 ◽  
Vol 10 (1) ◽  
pp. 8 ◽  
Author(s):  
Muchtar Efendi ◽  
Henna Rya Sunoko ◽  
Widada Sulistya
Keyword(s):  
Climate Change ◽  
Mixed Method ◽  
Public Perception ◽  
Quantitative Methods ◽  
Secondary Data ◽  
Study Data ◽  
Primary Data ◽  
Purposive Sampling ◽  
Study Results ◽  
The Impact

ABSTRAK Dampak terhadap pemanasan global adalah terjadinya perubahan iklim yang berpengaruh terhadap kondisi ekosistem Daerah Aliran Sungai (DAS). Kondisi ini menyebabkan penurunan tingkat kesejahteraan masyarakat dan meningkatkan tingkat kerentanan masyarakat. Penelitian ini bertujuan melakukan analisis tingkat kerentanan masyarakat terhadap perubahan iklim di Sub DAS Garang Hulu. Penelitian ini merupakan penelitian deskriptif-eksploratif dengan menggunakan pendekatan metode kombinasi kualititatif dan kuantitatif (mixed method). Data sekunder dikumpulkan melalui kegiatan studi literatur dan desk study. Data primer berupa persepsi masyarakat dengan wawancara mendalam dengan metode purposive sampling. Penilaian kerentanan masyarakat terhadap perubahan iklim menggunakan fungsi dari tiga komponen, yaitu paparan, kepekaan, dan kemampuan adaptasi. Hasil analisis kerentanan masyarakat ditampilkan dalam bentuk peta-peta dengan bantuan Sistem Informasi Geografi (SIG). Hasil kajian menunjukkan bahwa tingkat kerentanan masyarakat terhadap perubahan iklim didominasi dalam kategori rendah sampai dengan sedang dengan persentase 73.83%. Daerah yang memiliki kerentanan tinggi adalah daerah Kecamatan Ungaran Timur dan kelurahan Sukorejo di Kota Semarang. Kata Kunci : DAS, Kerentanan, Paparan, Kepekaan, Kemampuan Adaptasi ABSTRACT The impact of global warming is climate change affecting the condition of Watershed Ecosystem. This condition causes the decreasing in the level of social welfare and the increasing  level of vulnerability of  living community. This study was aimed  to analyze the level of vulnerability of living communities due to climate change in Garang Hulu sub-watersheds . This research was a descriptive-explorative approach by using a combination of qualititative and quantitative methods (mixed method). Secondary data were collected through the study of literature and desk study. Primary data were taken in the form of public perception along with  indepth interviews. Respondents were chosen through purposive sampling method. Assessment of the  social vulnerability to climate change was using a function of three components, namely the exposure, sensitivity, and adaptability. The results of the vulnerability analysis were presented in the form of maps using the GIS. The study results showed that the level of vulnerability of communities to climate change was dominated by low category to moderate with the percentage of 73.83%. Areas that had a high vulnerability were East Ungaran local district and Sukorejo village in Semarang. Key Words : watershed, vulnerability, exposure, sensitivity, adaptability.

scholarly journals Evaluating Anti-infective Drugs in the Resistant Pathogen Setting: Can We Use External Controls?

2017 ◽  
Vol 9 (1) ◽  
Author(s):  
Scott R Evans ◽  
John Powers
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
Patient Characteristics ◽  
Controlled Trials ◽  
Advantages And Disadvantages ◽  
Lack Of Information ◽  
Study Results ◽  
New Treatments ◽  
The Impact

AbstractDecreased efficacy of antibiotics due to resistant pathogens has created a need for the development of more effective medical interventions. Despite the increasing prevalence of pathogens resistant to one or more drugs, identifying and enrolling participants into clinical trials that evaluate new interventions for the treatment of some diseases can be challenging given the low prevalence of disease in which there are no effective treatments. Thus researchers might be tempted to consider externally-controlled trials that may allow for a reduction of the necessary number of prospectively-identified trial participants, thus easing recruitment burden and resulting in more timely trial completion relative to randomized controlled trials. We discuss advantages and disadvantages in externally controlled trials and review requirements for a valid externally-controlled trial. As ECTs are subject to the bias of observational studies, the criteria for a valid ECT should be carefully evaluated before these designs are implemented. Given considerable variation in study results in the resistant pathogen setting, the lack of information on important patient characteristics that may confound estimates of treatment effects, as well as the improvements in medical practice and evolving antibiotic resistance, the use of ECTs in the resistant pathogen setting, is not recommended. ECTs should be should be limited to specific situations where superiority of the effect of the new intervention is dramatic, the usual course of the disease highly predictable, the endpoints are objective (e. g., all-cause mortality) and the impact of baseline and treatment variables on outcomes is well characterized. Given that the resistant pathogen setting does not satisfy these criteria, we conclude that that randomized clinical trials are needed to evaluate new treatments for resistant pathogens. Innovative approaches to trial design that may ease recruitment burden while evaluating the benefits and harms of new treatments are being developed and utilized.

Friendship and money: A qualitative study of service users’ experiences of participating in a supported socialisation programme

2018 ◽  
Vol 64 (4) ◽  
pp. 326-334 ◽  
Author(s):  
Ann Sheridan ◽  
Donal O’Keeffe ◽  
Barbara Coughlan ◽  
Kate Frazer ◽  
Johnathan Drennan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Leisure Activities ◽  
Trial Participation ◽  
Service Users ◽  
Employment Barriers ◽  
Social Leisure ◽  
Social Opportunities ◽  
Qualitative Component ◽  
Randomised Controlled ◽  
The Impact

Background: Social opportunities can be limited in the lives of people with enduring mental illness (EMI) due to psychiatric stigma, restricted home environments and employment barriers. Supported socialisation programmes have the potential to redress the impact of social isolation. Aim: To explore the experiences of service users with EMI taking part in a supported socialisation programme, using written diary entries. Methods: This article reports on the qualitative component of a randomised controlled trial of supported socialisation for people with EMI (published previously in this journal). Trial participation involved (1) being matched with a volunteer partner and engaging in social/leisure activities while receiving a stipend of €20 or (2) receiving this stipend only and engaging in self-driven socialisation. Participants completed written diaries documenting their perspectives on their experiences of supported socialisation. Data were analysed using Thematic Analysis. Results: Experiences of participation were characterised by involvement ‘normalising’ life, fostering a sense of connectedness, improving physical health, and facilitating engagement with culture. Taking part helped participants integrate socialising into their identity, enhanced their perceived capacity to be social, and cemented/expanded social networks. Participants also experienced significant obstacles to socialisation. Conclusion: Supported socialisation can increase confidence, social competence and self-agency; buffer against psychiatric stigma; build social capital; and afford opportunities to enhance social integration, inclusion and belonging.

scholarly journals Effectiveness of the ABCDEF bundle on delirium, functional outcomes and quality of life in intensive care patients: a study protocol for a randomised controlled trial with embedded process evaluation

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044814
Author(s):  
Kellie Sosnowski ◽  
Marion Mitchell ◽  
Marie Cooke ◽  
Hayden White ◽  
Lynette Morrison ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intensive Care ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Study Results ◽  
Abcdef Bundle ◽  
Randomised Controlled

IntroductionHospital mortality for critically ill patients has decreased significantly throughout the developed world over the past two decades, attributable to improvements in the quality of intensive care, advances in critical care medicine and technologies that provide long-term multiorgan support. However, the long-term outcomes of intensive care unit (ICU) survivors is emerging as a real issue. Cognitive and physical impairments suffered by ICU survivors are common including profound weakness, pain and delirium which are inextricably linked. This study aims to determine the effectiveness of the Assess, prevent and manage pain; Both spontaneous awakening and spontaneous breathing trials; Choice of sedation and analgesia; Delirium: assess, prevent and manage; Early mobility and exercise; Family engagement and empowerment (ABCDEF) bundle in reducing ICU-related short-term and long-term consequences of critical illness through a randomised controlled trial (RCT).Methods and analysisThe study will be a single-centre, prospective RCT. A total of 150 participants will be recruited and randomised to either receive the ABCDEF bundle protocol or non-protocolised standard care for the duration of the participant’s admission in the ICU. The primary outcome is delirium status measured using the Confusion Assessment Measure for ICU (CAM-ICU). Secondary outcomes include physical function measured by the Functional Independence Measure and quality of life measured by the European Quality of Life five dimensions, five-level questionnaire. A mixed-method process evaluation will contribute to understanding the experience of health teams who implement the ABCDEF bundle into practice.Ethics and disseminationEthics approval was provided by the Metro South Health Human Research Ethics Committee (HREC) (EC00167) and the Griffith University’s HREC prior to study commencement.Study results will be disseminated by presentations at conferences and via publications to peer-review journals.Trial registration numberACTRN12620000736943; Pre-results.

scholarly journals A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog Trial

2019 ◽  
Author(s):  
Iracema Leroi ◽  
Christopher J. Armitage ◽  
Fidéline Collin ◽  
Eric Frison ◽  
Mark Hann ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Process Data ◽  
Causal Mechanisms ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
The Uk ◽  
The Impact ◽  
Insight Into

Abstract Background: Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT. Methods and analysis: We will use a mixed method approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered, which will be important to scale the intervention in real world populations; (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries; and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes. Discussion: This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received, across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment. Trial registration number: ISRCTN17056211. Registered on 19 February 2018. http://www.isrctn.com/ISRCTN17056211

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