Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

BACKGROUND/AIMS: The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. METHODS: Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. RESULTS: The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over 2 years to promote and sustain engagement. The personal coaching intervention, alternatively, was primarily personal coaching with trained coaches based on a proven intervention, enhanced with a mobile application, but where all interactions with the technology were participant-initiated. CONCLUSION: The complexity and length of the technology-based randomized clinical trial created challenges in engagement and technology adaptation, which were generally discovered using novel remote monitoring technology and addressed using the adaptive intervention design. Investigators should plan to develop tools and procedures that explicitly support continuous remote monitoring of interventions to support adaptive intervention design in long-term, technology-based studies, as well as developing the interventions themselves.

Parent education and home-based behaviour analytic intervention: an examination of parents' perceptions of outcome

There is convincing evidence that applied behaviour analysis (ABA) offers a highly effective form of intervention for children with autistic spectrum disorder (ASD). There is less evidence, however, about how parents perceive and evaluate ABA programmes. In this paper an examination of parents’ perceptions of outcome is reported. Twenty-two questionnaires were completed by two groups of parents. The first group had just completed an introductory course in ABA and were in the early stages of implementing ABA programmes with their children. The second group had been involved in ABA education for more than 2 years. Overall, both groups of parents reported a positive impact of ABA on the lives of their children, their family life, and themselves. The long- term group reported that they had achieved complex goals with their children, whilst the short-term group reported an immediate positive impact on child and family functioning and parental self-esteem. Conclusions are drawn in the context of evidence-based practice.

The contribution of qualitative research in designing a complex intervention for secondary prevention of coronary heart disease in two different healthcare systems

Background: Developing complex interventions for testing in randomised controlled trials is of increasing importance in healthcare planning. There is a need for careful design of interventions for secondary prevention of coronary heart disease (CHD). It has been suggested that integrating qualitative research in the development of a complex intervention may contribute to optimising its design but there is limited evidence of this in practice. This study aims to examine the contribution of qualitative research in developing a complex intervention to improve the provision and uptake of secondary prevention of CHD within primary care in two different healthcare systems.

Methods: In four general practices, one rural and one urban, in Northern Ireland and the Republic of Ireland, patients with CHD were purposively selected. Four focus groups with patients (N = 23) and four with staff (N = 29) informed the development of the intervention by exploring how it could be tailored and integrated with current secondary prevention activities for CHD in the two healthcare settings. Following an exploratory trial the acceptability and feasibility of the intervention were discussed in four focus groups (17 patients) and 10 interviews (staff). The data were analysed using thematic analysis.

Results: Integrating qualitative research into the development of the intervention provided depth of information about the varying impact, between the two healthcare systems, of different funding and administrative arrangements, on their provision of secondary prevention and identified similar barriers of time constraints, training needs and poor patient motivation. The findings also highlighted the importance to patients of stress management, the need for which had been underestimated by the researchers. The qualitative evaluation provided depth of detail not found in evaluation questionnaires. It highlighted how the intervention needed to be more practical by minimising administration, integrating role plays into behaviour change training, providing more practical information about stress management and removing self-monitoring of lifestyle change.

Conclusion: Qualitative research is integral to developing the design detail of a complex intervention and tailoring its components to address individuals' needs in different healthcare systems. The findings highlight how qualitative research may be a valuable component of the preparation for complex interventions and their evaluation.

The SPHERE Study: Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411]

Background: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland.CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines.

Methods: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients. General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD. Patients are invited to attend regular four-monthly consultations over two years, during which targets and goals for secondary prevention are set and reviewed. The analysis will be strengthened by economic, policy and qualitative components.

Economic modelling of antenatal screening and ultrasound scanning programmes for identification of fetal abnormalities

Objective Within the framework of a health technology assessment and using an economic model, to determine the most clinically and cost effective policy of scanning and screening for fetal abnormalities in early pregnancy. Design A discrete event simulation model of 50,000 singleton pregnancies. Setting Maternity services in Scotland. Population Women during the first 24 weeks of their pregnancy. Methods The mathematical model was populated with data on uptake of screening, prevalence, detection and false positive rates for eight fetal abnormalities and with costs for ultrasound scanning and serum screening. Inclusion of abnormalities was based on the relative prevalence and clinical importance of conditions and the availability of data. Six strategies for the identification of abnormalities prenatally including combinations of first and second trimester ultrasound scanning and first and second trimester screening for chromosomal abnormalities were compared. Main outcome measures The number of abnormalities detected and missed, the number of iatrogenic losses resulting from invasive tests, the total cost of strategies and the cost per abnormality detected were compared between strategies. Results First trimester screening for chromosomal abnormalities costs more than second trimester screening but results in fewer iatrogenic losses. Strategies which include a second trimester ultrasound scan result in more abnormalities being detected and have lower costs per anomaly detected. Conclusions The preferred strategy includes both first and second trimester ultrasound scans and a first trimester screening test for chromosomal abnormalities. It has been recommended that this policy is offered to all women in Scotland.

Instrumental and interpretive methods in evaluating urban programmes

The turn within urban policy to address increasingly complex social, economic and environmental problems has exposed some of the fragility of traditional measurement models and their reliance on the rational paradigm. This article looks at the experiences of the European Union (EU) Programme for Peace and Reconciliation in Northern Ireland and its particular attempt to construct new District Partnerships to deliver area-based regeneration programmes. It highlights the need to combine instrumental and interpretative evaluation methods in an attempt to explain the wider contribution of governance to conflict resolution and participatory practice in local development. It concludes by highlighting the value of conceptual approaches that deal with the politics of evaluation and the distributional effects of policy interventions designed to create new relationships within and between multiple stakeholders.

Impact of Government Intervention on Employment Change and Plant Closure in Northern Ireland, 1983-97

Harris R. and Trainor M. (2007) Impact of government intervention on employment change and plant closure in Northern Ireland, 1983-97, Regional Studies 41, 51-63. Financial assistance to manufacturing industry is an important element of the industrial development policy in Northern Ireland. This paper uses the individual plant-level records of the Annual Respondents Database (ARD) for the Northern Ireland manufacturing sector (1983-97) matched to the plant-level details of financial support provided by the Industrial Development Board to examine the effect of selective financial assistance (SFA) on employment change and plant closure. It is found that SFA concentrated on protecting existing, rather than new, enterprises in terms of employment change. Using a hazard model, it is found that the receipt of SFA significantly reduced the probability of plant closure by, on average, between 15 and 24%.

The general and specific effects of educational programmes aimed at promoting awareness of and respect for diversity among young children

This article reports the findings of a mixed-method evaluation of a pilot educational programme undertaken with 6-7 year olds in a sample of primary schools in England with the aim of increasing their awareness of and respect for diversity through theatre, workshops and related teacher-led classroom activities. The qualitative feedback from the teachers involved was extremely positive and encouraging and an analysis of the actual impact of the pilot programme on the children’s attitudes and awareness, using an experimental design, demonstrated some positive effects. In particular, the programme was found to increase the children’s general awareness of diversity and their ability to recognise instances of exclusion. While not a planned objective of the pilot programme, the evaluation also examined whether it had any effects on the children’s attitudes to specific differences, in this particular case racial differences. Interestingly, however, no evidence was found of any change in the children’s racial attitudes. With this in mind the article suggests that there is a need to distinguish between the general and specific effects of such educational programmes. The article considers the implications of this for future work in the area and also stresses the need to undertake more thorough and rigorous evaluations of such initiatives.

Public Participation in Area-based Urban Regeneration Programmes

This paper reports the findings of research into the representation of local interests in area-based urban regeneration programmes in Northern Ireland and the Republic of Ireland. The two case studies are contextualised by a review of the promotion of public participation in urban regeneration in both parts of Ireland and theorised as a site of interaction between state agencies and civil society. It is argued that the practice of public participation is a hegemonic project, which, within urban regeneration, is operationalised through partnership structures. The paper concludes that many factors from within and outside the case study programmes affected their consultation processes. Therefore the design and implementation of regeneration programmes should be undertaken in the context of an understanding of the relationship between the state and civil society in the empirical case.

The University Programmes for Senior Citizens and their contribution of lifelong learning

The study addresses the essential features of University Programmes for senior citizens (PUM). It committed to the lifelong education through the integration of the elderly in the University. Part of the base that is learned during the entire life cycle, there is no age, no specific space for education. Learning is constructed from knowledge, abilities, skills and aptitudes that are enriched continuously. It is necessary to ensure the elderly to age in a healthy way. It calls for active ageing, effective tool against isolation and social exclusion. The aim is to discover aspects of the UNED Senior training programme that contribute to lifelong learning and satisfaction produced. The PUM are ways for the promotion of aging along with other activities aimed to enhance a creative leisure, access to culture, facilitate training on topics of interest and create a means of participation in all spheres of society. In this research has resorted to a mixed methodology. Their wealth combines the methods of quantitative and qualitative allowing us to obtain information and contrast from different perspectives. The purpose is to verify the results of the investigation. The sample consists of 639 students, 57 teachers and 15 coordinators. The results indicate that the PUM of the UNED Senior is highly satisfactory for those involved, by the adequacy between interests and expectations. Fruit of this research are the conclusions and suggestions for improvement.

Recapitulation of embryological programmes in renal fibrosis - The importance of epithelial cell plasticity and developmental genes

Chronic fibrosis represents the final common pathway in progressive renal disease. Myofibroblasts deposit the constituents of renal scar, thus crippling renal function. It has recently emerged that an important source of these pivotal effector cells is the injured renal epithelium. This review concentrates on the process of epithelial-mesenchymal transition (EMT) and its regulation. The role of the developmental gene, gremlin, which is reactivated in adult renal disease, is the subject of particular focus. This member of the cysteine knot protein superfamily is critical to the process of nephrogenesis but quiescent in normal adult kidney. There is increasing evidence that gremlin expression reactivates in diabetic nephropathy, and in the diseased fibrotic kidney per se. Known to antagonize members of the bone morphogenic protein (BMP) family, gremlin may also act downstream of TGF-beta in induction of EMT. An increased understanding of the extracellular modulation of EMT and, in particular, of the gremlin-BMP axis may result in strategies that can halt or reverse the devastating progression of chronic renal fibrosis. Copyright (c) 2006 S. Karger AG, Basel.

Overcoming health inequalities: A participative evaluation framework fit for the task

Aims: Healthcare providers are confronted with the claim that the distribution of health and healthcare provision is inherently unfair. There is also a growing awareness that the tools and methodologies applied in tackling health inequalities require further development. Evaluations as well as interventions usually focus on population-based indicators, but do not always provide guidance for frontline service evaluation and delivery. That is why the evaluation framework presented here focuses on facilitating local service development, service provider and user involvement, and the adequate representation of different population groups. Methods: A participative evaluation framework was constructed by drawing on six common success characteristics extrapolated from the published literature and policies on health inequalities. This framework was then applied to an intervention addressing women’s psychosocial health needs in order to demonstrate its utility in practice. Results: The framework provides healthcare professionals with an evidence-based tool for evaluating projects or programmes targeting health inequalities in ways that are responsive to local contexts and stakeholders. Conclusion: This participative evaluation framework supports the identification of meaningful psychosocial and contextual indicators for assessing the diverse health and social needs of service users. It uses multi-dimensional indicators to assess health and social care needs, to inform local service development, and to facilitate the exchange of knowledge between researchers, service providers, and service users. The inherent responsiveness enables rigorous yet flexible action on local health inequalities.

Are rural development programmes socially inclusive? Social inclusion, civic engagement, participation, and social capital: Exploring the differences

Considerable importance is attached to social exclusion/inclusion in recent EU rural development programmes. At the national/regional operation of these programmes groups of people who are not participating are often identified as ‘socially excluded groups’. This article contends that rural development programmes are misinterpreting the social processes of participation and consequently labelling some groups as socially excluded when they are not. This is partly because of the interchangeable and confused use of the concepts social inclusion, social capital and civic engagement, and partly because of the presumption that to participate is the default position. Three groups identified as socially excluded groups in Northern Ireland are considered. It is argued that a more careful analysis of what social inclusion means, what civic engagement means, and why participation is presumed to be the norm, leads to a different conclusion about who is excluded. This has both theoretical and policy relevance for the much used concept of social inclusion.

Government intervention in a dynamic economy

From the late 1970s onwards, the view that government intervention could provide a means of overcoming market failure in advanced was increasingly questioned. For some, intervention was to be discouraged because it interfered with individual liberty. For others, what was problematic was the welfare economist's assumption of an autonomous state acting in the public interest. Finally, there was the issue of the state's ability to achieve what it set out to do. Government failure it was argued was just as pervasive as market failure and no antidote to it. This paper critically evaluates such arguments in relation to competition, industrial change, innovation, and competitive advantage in production.

Can they go it alone? Addressing criticisms of coteaching.

This paper responds to Wassell and LaVan’s paper on the transition from a preservice coteaching experience to independent teaching as a beginning inservice teacher. Wassell and LaVan describe coteaching as an alternative to traditional teaching. In our response, we argue that coteaching can also be applied alongside independent teaching in preservice courses, as opposed to an alternative to independent teaching, which has been shown to alleviate some of the transition issues described by Wassell and LaVan. We then present a critical discussion of different models and vocabularies of coteaching which apply in different sociocultural settings to expand the concept of coteaching. We attempt to extend Wassell and LaVan’s use of Guba and Lincoln’s (Fourth generation evaluation, 1989) authenticity criteria from the research methodology towards considering the criteria also as a framework for coteaching as practice for preservice and cooperating teachers. Finally, we reflect on the role of critical ethnography in Wassell and LaVan’s study in terms of the researchers’ intervention and whether improvements in the transition can be effectively introduced which do not require such intervention. We conclude our discussion with some suggestions to take forward this important work.