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.

Design and Development of a Film-based Intervention about Teenage Men and Unintended Pregnancy: Applying the Medical Research Council Framework in Practice

Following the UK Medical Research Council’s (MRC) guidelines for the development and evaluation of complex interventions, this study aimed to design, develop and optimise an educational intervention about young men and unintended teenage pregnancy based around an interactive film. The process involved identification of the relevant evidence base, development of a theoretical understanding of the phenomenon of unintended teenage pregnancy in relation to young men, and exploratory mixed methods research. The result was an evidence-based, theory-informed, user-endorsed intervention designed to meet the much neglected pregnancy education needs of teenage men and intended to increase both boys’ and girls’ intentions to avoid an unplanned pregnancy during adolescence. In prioritising the development phase, this paper addresses a gap in the literature on the processes of research-informed intervention design. It illustrates the application of the MRC guidelines in practice while offering a critique and additional guidance to programme developers on the MRC prescribed processes of developing interventions. Key lessons learned were: 1) know and engage the target population and engage gatekeepers in addressing contextual complexities; 2) know the targeted behaviours and model a process of change; and 3) look beyond development to evaluation and implementation.

Using a mixed design study to develop a breast screening intervention among Chinese women in the UK

Breast cancer is the most common cancer among Chinese women living in the UK. However the literature suggests that Chinese women are less likely to attend breast screening than white British women. No studies have been conducted to explore reasons for low attendance among this specific population. The purpose of this thesis was to understand the psycho-social factors related to breast cancer prevention and screening among Chinese women in the UK, and then to inform a breast screening intervention design. Three studies were conducted. The first was a systematic review of interventions to increase breast screening among Chinese women living in Western countries. The second and third studies used focus groups to explore Chinese women’s beliefs about breast cancer prevention and screening practices among older and younger generations. Finally, Intervention Mapping was used to synthesise the findings of the focus groups with those of the systematic review to design an empirical and theoretical evidence based breast screening intervention directed at Chinese women who are non-adherent to the NHS Breast Screening Programme. The qualitative findings revealed that older participants held a more holistic view of health maintenance, and had less knowledge about breast cancer and its causes than younger participants. They showed positive attitudes to breast screening and most had responded to receiving a mammography invitation. Language was a key barrier to older participants using medical care and obtaining health-related information. Younger participants expressed high dissatisfaction with health care in UK and showed a strong ‘neo-fatalistic’ view of breast cancer prevention, believing the main cause of breast cancer to be genetic predisposition. The synthesis of findings suggest that healthcare providers need to take Chinese cultural and language concerns, but also the differences between generations, into account when designing and implementing breast screening services and educational programmes which target Chinese women.

Barriers to the acceptance of road safety programmes among rural road users : developing a brief intervention

Motorised countries have more fatal road crashes in rural areas than in urban areas. In Australia, over two thirds of the population live in urban areas, yet approximately 55 percent of the road fatalities occur in rural areas (ABS, 2006; Tziotis, Mabbot, Edmonston, Sheehan & Dwyer, 2005). Road and environmental factors increase the challenges of rural driving, but do not fully account for the disparity. Rural drivers are less compliant with recommendations regarding the “fatal four” behaviours of speeding, drink driving, seatbelt non-use and fatigue, and the reasons for their lower apparent receptivity for road safety messages are not well understood. Countermeasures targeting driver behaviour that have been effective in reducing road crashes in urban areas have been less successful in rural areas (FORS, 1995). However, potential barriers to receptivity for road safety information among rural road users have not been systematically investigated. This thesis aims to develop a road safety countermeasure that addresses three areas that potentially affect receptivity to rural road safety information. The first is psychological barriers of road users’ attitudes, including risk evaluation, optimism bias, locus of control and readiness to change. A second area is the timing and method of intervention delivery, which includes the production of a brief intervention and the feasibility of delivering it at a “teachable moment”. The third area under investigation is the content of the brief intervention. This study describes the process of developing an intervention that includes content to address road safety attitudes and improve safety behaviours of rural road users regarding the “fatal four”. The research commences with a review of the literature on rural road crashes, brief interventions, intervention design and implementation, and potential psychological barriers to receptivity. This literature provides a rationale for the development of a brief intervention for rural road safety with a focus on driver attitudes and behaviour. The research is then divided into four studies. The primary aim of Study One and Study Two is to investigate the receptivity of rural drivers to road safety interventions, with a view to identifying barriers to the efficacy of these strategies.

Does metabolic compensation explain the majority of less-than-expected weight loss in obese adults during a short-term severe diet and exercise intervention?

Objective: We investigated to what extent changes in metabolic rate and composition of weight loss explained the less-than-expected weight loss in obese men and women during a diet-plus-exercise intervention. Design: 16 obese men and women (41 ± 9 years; BMI 39 ± 6 kg/m2) were investigated in energy balance before, after and twice during a 12-week VLED (565–650 kcal/day) plus exercise (aerobic plus resistance training) intervention. The relative energy deficit (EDef) from baseline requirements was severe (74-87%). Body composition was measured by deuterium dilution and DXA and resting metabolic rate (RMR) by indirect calorimetry. Fat mass (FM) and fat-free mass (FFM) were converted into energy equivalents using constants: 9.45 kcal/gFM and 1.13 kcal/gFFM. Predicted weight loss was calculated from the energy deficit using the '7700 kcal/kg rule'. Results: Changes in weight (-18.6 ± 5.0 kg), FM (-15.5 ± 4.3 kg), and FFM (-3.1 ± 1.9 kg) did not differ between genders. Measured weight loss was on average 67% of the predicted value, but ranged from 39 to 94%. Relative EDef was correlated with the decrease in RMR (R=0.70, P<0.01) and the decrease in RMR correlated with the difference between actual and expected weight loss (R=0.51, P<0.01). Changes in metabolic rate explained on average 67% of the less-than-expected weight loss, and variability in the proportion of weight lost as FM accounted for a further 5%. On average, after adjustment for changes in metabolic rate and body composition of weight lost, actual weight loss reached 90% of predicted values. Conclusion: Although weight loss was 33% lower than predicted at baseline from standard energy equivalents, the majority of this differential was explained by physiological variables. While lower-than-expected weight loss is often attributed to incomplete adherence to prescribed interventions, the influence of baseline calculation errors and metabolic down-regulation should not be discounted.

Clinical skin examination outcomes after a video-based behavioral intervention analysis from a randomized clinical trial

Importance Older men are at risk of dying of melanoma. Objective To assess attendance at and clinical outcomes of clinical skin examinations (CSEs) in older men exposed to a video-based behavioral intervention. Design, Setting, and Participants This was a behavioral randomized clinical trial of a video-based intervention in men aged at least 50 years. Between June 1 and August 31, 2008, men were recruited, completed baseline telephone interviews, and were than randomized to receive either a video-based intervention (n = 469) or brochures only (n = 461; overall response rate, 37.1%) and were again interviewed 7 months later (n = 870; 93.5% retention). Interventions Video on skin self-examination and skin awareness and written informational materials. The control group received written materials only. Main Outcomes and Measures Participants who reported a CSE were asked for the type of CSE (skin spot, partial body, or whole body), who initiated it, whether the physician noted any suspicious lesions, and, if so, how lesions were managed. Physicians completed a case report form that included the type of CSE, who initiated it, the number of suspicious lesions detected, how lesions were managed (excision, nonsurgical treatment, monitoring, or referral), and pathology reports after lesion excision or biopsy. Results Overall, 540 of 870 men (62.1%) self-reported a CSE since receiving intervention materials, and 321 of 540 (59.4%) consented for their physician to provide medical information (received for 266 of 321 [82.9%]). Attendance of any CSE was similar between groups (intervention group, 246 of 436 [56.4%]; control group, 229 of 434 [52.8%]), but men in the intervention group were more likely to self-report a whole-body CSE (154 of 436 [35.3%] vs 118 of 434 [27.2%] for control group; P = .01). Two melanomas, 29 squamous cell carcinomas, and 38 basal cell carcinomas were diagnosed, with a higher proportion of malignant lesions in the intervention group (60.0% vs 40.0% for controls; P = .03). Baseline attitudes, behaviors, and skin cancer history were associated with higher odds of CSE and skin cancer diagnosis. Conclusions and Relevance A video-based intervention may increase whole-body CSE and skin cancer diagnosis in older men. Trial Registration: anzctr.org.au Identifier: ACTRN12608000384358

Evaluation of a community-based intervention to promote physical activity in youth : lessons from active winners

Purpose To test the effects of a community-based physical activity intervention designed to increase physical activity and to conduct an extensive process evaluation of the intervention. Design Quasi-experimental. Setting Two rural communities in South Carolina. One community received the intervention, and the other served as the comparison. Subjects Public school students who were in fifth grade at the start of the study (558 at baseline) were eligible to participate. A total of 436 students participated over the course of the study. Intervention The intervention included after-school and summer physical activity programs and home, school, and community components designed to increase physical activity in youth. The intervention took place over an 18-month period. Measures. Students reported after-school physical activity at three data collection points (prior to, during, and following the intervention) using the Previous Day Physical Activity Recall (PDPAR). They also completed a questionnaire designed to measure hypothesized psychosocial and environmental determinants of physical activity behavior The process evaluation used meeting records, documentation of program activities, interviews, focus groups, and heart rate monitoring to evaluate the planning and implementation of the intervention. Results There were no significant differences in the physical activity variables and few significant differences in the psychosocial variables between the intervention and comparison groups. The process evaluation indicated that the after-school and summer physical activity component of the intervention was implemented as planned, but because of resource and time limitations, the home, school, and community components were not implemented as planned. Conclusions The intervention did not have a significant effect on physical activity in the target population of children in the intervention community. This outcome is similar to that reported in other studies of community-based physical activity intervention.

Improving appropriate polypharmacy for older people in primary care: selecting components of an evidence-based intervention to target prescribing and dispensing.

Background
The use of multiple medicines (polypharmacy) is increasingly common in older people. Ensuring that patients receive the most appropriate combinations of medications (appropriate polypharmacy) is a significant challenge. The quality of evidence to support the effectiveness of interventions to improve appropriate polypharmacy is low. Systematic identification of mediators of behaviour change, using the Theoretical Domains Framework (TDF), provides a theoretically robust evidence base to inform intervention design. This study aimed to (1) identify key theoretical domains that were perceived to influence the prescribing and dispensing of appropriate polypharmacy to older patients by general practitioners (GPs) and community pharmacists, and (2) map domains to associated behaviour change techniques (BCTs) to include as components of an intervention to improve appropriate polypharmacy in older people in primary care.

Methods
Semi-structured interviews were conducted with members of each healthcare professional (HCP) group using tailored topic guides based on TDF version 1 (12 domains). Questions covering each domain explored HCPs’ perceptions of barriers and facilitators to ensuring the prescribing and dispensing of appropriate polypharmacy to older people. Interviews were audio-recorded and transcribed verbatim. Data analysis involved the framework method and content analysis. Key domains were identified and mapped to BCTs based on established methods and discussion within the research team.

Results
Thirty HCPs were interviewed (15 GPs, 15 pharmacists). Eight key domains were identified, perceived to influence prescribing and dispensing of appropriate polypharmacy: ‘Skills’, ‘Beliefs about capabilities’, ‘Beliefs about consequences’, ‘Environmental context and resources’, ‘Memory, attention and decision processes’, ‘Social/professional role and identity’, ‘Social influences’ and ‘Behavioural regulation’. Following mapping, four BCTs were selected for inclusion in an intervention for GPs or pharmacists: ‘Action planning’, ‘Prompts/cues’, ‘Modelling or demonstrating of behaviour’ and ‘Salience of consequences’. An additional BCT (‘Social support or encouragement’) was selected for inclusion in a community pharmacy-based intervention in order to address barriers relating to interprofessional working that were encountered by pharmacists.

Conclusions
Selected BCTs will be operationalised in a theory-based intervention to improve appropriate polypharmacy for older people, to be delivered in GP practice and community pharmacy settings. Future research will involve development and feasibility testing of this intervention.

Coconstruction des composantes d'un programme d'intervention en soutien à la résilience de familles dont un adolescent est atteint d'un traumatisme craniocérébral

La vie de famille avec un adolescent comporte son lot de défis. Les émotions de l’adolescent qui se présentent parfois comme des montagnes russes peuvent rendre les relations tendues et difficiles au sein de la cellule familiale, voire même au-delà de celle-ci. Par son caractère inattendu, l’avènement d’un traumatisme craniocérébral (TCC) chez l’adolescent vient fragiliser encore davantage la dynamique familiale. En outre, la myriade d’impacts engendrés par le TCC contraint la famille à modifier son projet de vie en s’investissant ensemble pour le reconstruire. La résilience devant une situation de traumatisme ne se manifeste pas de la même façon pour toutes les familles qui y sont confrontées. Certaines d’entre elles réussissent à se transformer positivement, tandis que d’autres n’y parviennent pas ou manifestent plus de difficultés. Il convient alors d’actualiser des approches de soins interdisciplinaires centrées sur la famille qui favoriseraient la reconnaissance des éléments pouvant soutenir son processus de résilience à travers cette épreuve et, enfin, aider à transformer son projet de vie. Avec comme perspective disciplinaire le modèle humaniste des soins infirmiers (Cara, 2012; Cara & Girard, 2013; Girard & Cara, 2011), cette étude qualitative et inductive (LoBiondo-Wood, Haber, Cameron, & Singh, 2009), soutenue par une approche collaborative de recherche (Desgagné, 1997), a permis la coconstruction des composantes d’un programme d’intervention en soutien à la résilience familiale, avec des familles dont un adolescent est atteint d’un TCC modéré ou sévère et des professionnels de la réadaptation. Le modèle de développement et de validation d’interventions complexes (Van Meijel, Gamel, Van Swieten-Duijfjes, & Grypdonck, 2004) a structuré la collecte des données en trois volets. Le premier volet consistait à identifier les composantes du programme d’intervention selon les familles (n=6) et les professionnels de la réadaptation (n=5). La priorisation et la validation des composantes du programme d’intervention, soit respectivement le deuxième et troisième volets, se sont réalisées auprès de ces mêmes familles (n=6 au volet 2 et n=4 au volet 3) et professionnels de la réadaptation (n=5 aux volets 2 et 3). Le processus d’analyse des données (Miles & Huberman, 2003) a repéré cinq thèmes intégrateurs, considérés comme les composantes du programme d’intervention en soutien à la résilience familiale à la suite du TCC modéré ou sévère d’un adolescent. Ce sont : 1) les caractéristiques de la famille et ses influences; 2) les stratégies familiales positives; 3) le soutien familial et social; 4) la prise en charge de l’aspect occupationnel et; 5) l’apport de la communauté et des professionnels de la santé. Les résultats issus de ce processus de coconstruction ont produit une matrice solide, suffisamment flexible pour pouvoir s’adapter aux différents contextes dans lesquels évoluent les familles et les professionnels de la réadaptation. Cette étude offre en outre des avenues intéressantes tant pour les praticiens que pour les gestionnaires et les chercheurs en sciences infirmières et dans d’autres disciplines quant à la mise en place de stratégies concrètes visant à soutenir le processus de résilience des familles dans des situations particulièrement difficiles de leur vie.

Perceptions et réactions des soignants et membres de famille à l’égard d’une intervention de réminiscence auprès de personnes atteintes de démence légère à modérée en soins de longue durée

La majorité des personnes atteintes de démence en soins de longue durée (SLD) souffre d’une détérioration de la cognition, des interactions sociales, de la santé mentale et de la qualité de vie (QdV). Par conséquent, les proches aidants et les soignants de cette population peuvent éprouver des difficultés, tel que le stress, en raison de la complexité du syndrome. Il s’avère essentiel de valider des interventions psychosociales adaptées à la population atteinte de démence et à ses aidants. La réminiscence, une intervention psychosociale misant sur les capacités résiduelles des personnes atteintes de démence, se fonde sur la remémoration des souvenirs anciens agréables. L’objectif général du mémoire était de valider la mise en œuvre d’une intervention de réminiscence menée par le personnel soignant auprès des personnes atteintes de démence et leurs familles dans un centre de SLD, en faisant appel aux avis experts des soignants et des familles des personnes atteintes de démence dans le contexte d’entrevues. Une évaluation pré-post intervention a permis de mesurer la santé mentale et la QdV des personnes atteintes de démence avant l’intervention, une semaine après et trois mois après l’intervention. Les résultats indiquent que la réminiscence a été bien appréciée par les soignants, les personnes atteintes de démence et leurs familles, et valident sa mise en œuvre en SLD. Des améliorations significatives (Wilcoxon p < 0,025) à court et à long terme ont été observées au niveau de la santé mentale et la QdV des personnes atteintes de démence.

An argument for using participatory approaches for the design of online health interventions targeted at young women

The Internet is becoming an increasingly important portal to health information and means for promoting health in user populations. As the most frequent users of online health information, young women are an important target population for e-health promotion interventions. Health-related websites have traditionally been generic in design, resulting in poor user engagement and affecting limited impacts on health behaviour change. Mounting evidence suggests that the most effective health promotion communication strategies are collaborative in nature, fully engaging target users throughout the development process. Participatory design approaches to interface development enable researchers to better identify the needs and expectations of users, thus increasing user engagement in, and promoting behaviour change via, online health interventions. This article introduces participatory design methods applicable to online health intervention design and presents an argument for the use of such methods in the development of e-Health applications targeted at young women.

A theory-informed approach to developing visually mediated interventions to change behaviour using an asthma and physical activity intervention exemplar

Funding for this study was received from the Chief Scientist Office for Scotland. We would like to thank Asthma UK and Asthma UK Scotland for facilitating the advertisement of the study pilot and consultative user group. Thanks to Dr Mark Grindle for his helpful discussions concerning narrative. Thanks also to Mr Mark Haldane who designed the characters, backgrounds, and user interface used within the 3D computer animation. Particular thanks to the participants of the consultative user group for their enthusiasm, comments, and suggestions at all stages of the intervention design.

A short-term evaluation of a school-based early adolescent injury prevention program

This paper reports on the development of a school-based intervention to reduce risk-taking and associated injuries. There is limited but important evidence that intervention design should ensure participation does not lead to an increase in target risk behaviors with some studies in alcohol and drug prevention finding unexpected negative effects. The short-term evaluation of Skills for Preventing Injury in Youth (SPIY) examined change in interpersonal violence, alcohol and transport-related risks. Intervention (n = 360) and comparison (n = 180) students were surveyed pre/post-intervention. A qualitative analysis based on focus groups (70 students) explored experiences of change. Findings indicate significant positive changes reinforced by students’ reports. A decrease in reported risk-taking for the intervention group and an increase in the comparison group were observed. These findings endorse SPIY as a useful curriculum approach to reducing injuries and lend support to the future conduct of a long-term outcome evaluation.

Infant wrapping as an evidence-based strategy to encourage settling and the utilisation of the supine sleep position

Objective: To identify knowledge, attitudes and practices of child health nurses relating to infant wrapping as an effective settling/sleep strategy. Methods: A pre-test/post-test intervention design was used to explore knowledge, attitudes and practices relating to wrapping in a sample of child health nurses (n=182): a) pre-test survey; b) educational intervention incorporating evidence relating to infant wrapping; SIDS&KIDS endorsed infant wrapping pamphlet; Safe Sleeping recommendations. Emphasis was placed on infant wrapping as an effective settling strategy for parents to use as an alternative to prone positioning; c) post-test survey to evaluate intervention effectiveness. Results: Pretest results identified wide variation in nurses’ knowledge, attitudes and practices of infant wrapping as a settling/sleep strategy. The intervention increased awareness of wrapping guidelines and self-reported practices relating to parent advice. Significant positive changes in nurses’ awareness of wrapping guidelines (p<0.001); to wrap in supine position only (p<0.001); and parental advice to use wrapping as an alternative strategy to prone positioning to assist settling/sleep (p<0.01), were achieved post-test. Conclusions: Managing unsettled infants and promoting safe sleeping practices are issues routinely addressed by child health nurses working with parents of young infants. Queensland has a high incidence of prone sleeping. Infant wrapping is an evidence-based strategy to improve settling and promote supine sleep consistent with public health recommendations. Infant wrapping guidelines are now included in Queensland Health’s state policy and Australian SIDSandKids information relating to safe infant sleeping. In communicating complex health messages to parents, health professionals have a key role in reinforcing safe sleeping recommendations and offering safe, effective settling/sleep strategies to address the non-recommended use of prone positioning for unsettled infants.