Interactive Digital Intervention Research Articles

P651 A randomised controlled trial of IBD-BOOST, a digital cognitive behavioural self-management programme for fatigue, and/or pain, and/or faecal incontinence in inflammatory bowel disease

Abstract Background Many people with IBD experience fatigue, pain and faecal incontinence (FI), impacting quality of life (QoL). We developed an interactive digital online self-management intervention (IBD-BOOST) based on a theoretically informed logic model and cognitive behavioural techniques, to treat these symptoms. We aimed to assess if IBD-BOOST, alongside health care professional (HCP) support and care as usual (CAU), provides greater relief from symptoms and improvement of QoL compared with CAU alone. Methods We conducted a pragmatic multi-centre two-arm parallel group randomised controlled trial (RCT) recruiting patients from clinics and national registries who rated the impact of fatigue and/or pain and/or FI as ≥5/10. Those in the IBD-BOOST arm received 6 months access to the 12-session IBD-BOOST programme, a 30-minute telephone support call with a trained HCP after session 1 and weekly in-site email messages from the HCP for 3 months. The UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months were dual primary outcomes (alpha=0.025 was considered statistically significant as there were two primary outcomes). Other secondary outcomes, including individual symptoms, were measured at 6 and 12 months. Complier-averaged causal effects (CACE), sensitivity and pre-specified subgroup analyses were conducted. Results 780 participants were randomised (Figure 1), 432 with Crohn’s disease, 348 with ulcerative colitis or other IBD; 520 (66.7%) were female, mean age 49 years. At 6 months, both UK-IBDQ and GRSR were similar between the BOOST and CAU arms, p=0.19 for IBDQ and p=0.39 for GRSR (Table 1). Adverse events were similar between groups. FI score and EQ5D utility score (secondary outcomes) were significantly in favour of IBD-BOOST at 6 months, but pain and fatigue were no different. 57% of the intervention group completed a pre-defined minimum “dose” of 4 sessions (i.e. compliers). The CACE analysis suggested that compliers were more likely to report better QoL (p=0.03). Subgroup analysis of those meeting criteria for irritable bowel syndrome (IBS), showed that IBD-BOOST was more effective in improving IBDQ and GRSR at 6 months when compared with CAU for the IBD-IBS group (pinteraction=0.015 and 0.046, respectively). Conclusion This large RCT found that IBD-BOOST did not improve IBDQ and GRSR in patients with IBD and fatigue and/or pain and/or FI relative to CAU. Participants reported less FI at 6 and 12 months. Those who complied with the intervention showed a more pronounced IBDQ treatment effect. Those with IBD-IBS at baseline improved more than those without, suggesting a possible for further effectiveness research on IBD-BOOST. Trial registration: ISRCTN71618461

An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial.

Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed--a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654. DERR1-10.2196/43645.

A cluster randomised, 16-week, parallel-group multicentre trial to compare the effectiveness of a digital school-based cognitive behavioural resilience/wellbeing-building intervention targeting emotional and behavioural problems in vulnerable Year 4 primary school children in whole classes, to the usual school curriculum: a study protocol to the “CUES for Schools” trial

BackgroundAround 10% of school-aged children experience mental health difficulties. Many more are ‘vulnerable’: experiencing emotional and/or behavioural problems reaching clinical levels, and thus at greatest risk of future mental illness. The trial aim is to evaluate the effectiveness of the CUES for schools programme in reducing emotional and behavioural problems in vulnerable children.MethodsThe “CUES for Schools” study is a multicentre cluster randomised controlled trial in primary schools in south east England. Schools will be randomised to receive the usual school curriculum, or the CUES programme (1:1). We aim to enrol 74 schools (5550 children including 2220 vulnerable children). CUES is a whole-class teacher-facilitated interactive digital cognitive-behavioural intervention, delivered as 24 short (20-min) modules over 12 weeks, targeting emotional/behavioural regulation skills. Children self-report emotional/behavioural problems at baseline, 8, and 16 weeks, and wellbeing and cognitive vulnerability at 0 and 16 weeks. Adverse events are assessed at 8 and 16 weeks. Teachers rate classroom behaviour at baseline and 16 weeks. School senior leadership teams and individual teachers consent to involvement in the study; parents can opt their child out of CUES sessions, assessments, or research. Children can similarly opt out and assent to research participation. The primary objective of this trial is to evaluate the effectiveness of CUES for schools compared to the usual school curriculum in improving emotional/behavioural problems for vulnerable Year 4 (8–9 years old) children at 16 weeks post-randomisation, as measured using a standardised questionnaire designed for primary schools. The secondary objective is to investigate the impact of the CUES for schools programme on both vulnerable and non-vulnerable children on wellbeing and teacher-rated classroom behaviour.DiscussionThe study will show whether CUES for schools is more effective than the usual curriculum in reducing emotional and behavioural problems in vulnerable Year 4 children, and thus reducing the risk of mental health difficulties in later adolescent and adult life. As a digital, teacher-facilitated intervention, CUES for schools can be readily implemented, at minimal cost. If effective, CUES for schools therefore has the potential to reduce the impact of emotional/behavioural difficulties on children’s learning, behaviour, and relationships and the burden of future mental health morbidity.Trial registrationTrial Registration ISRCTN11445338. Registered on September 12, 2022.

A comic based interactive digital intervention to enhance facilitation skills of nurse mentors in public facilities – results of a pilot intervention in Bihar, India

ABSTRACT Background Various trainings are designed to educate nurses to become simulation educators. However, there are no good strategies to sustain their learnings and keep them engaged. We developed a series of 10 interactive digital storytelling comic episodes ‘ The Adventures of Super Divya (SD)’ to strengthen simulation educator’s facilitation knowledge, skills, confidence, and engagement. This endline evaluation presents results on the change in knowledge after watching the episodes and retention of that knowledge over 10 months. Objectives The objectives of this pilot study are to: 1) assess the change in knowledge between the baseline and post-episode surveys; and 2) understand the retention of knowledge between the post-episode and the endline survey. Methods A human-centred design was used to create the episodes grounded in the lived experience of nurse simulation educators. The heroine of the comic is Divya, a ‘Super Facilitator’ and her nemesis is Professor Agni who wants to derail simulation as an educational strategy inside obstetric facilities. Professor Agni’s schemes represent real-life challenges; and SD uses effective facilitation and communication to overcome them. The episodes were shared with a group of nurse mentors (NM) and nurse mentor supervisors (NMS) who were trained to be champion simulation educators in their own facilities. To assess change in knowledge, we conducted a baseline, nine post-episode surveys and an endline survey between May 2021 and February 2022. Results A total 110 NM and 50 NMS watched all 10 episodes and completed all of the surveys. On average, knowledge scores increased by 7–9 percentage points after watching the episodes. Comparison of survey responses obtained between 1 and 10 months suggest that the gain in knowledge was largely retained over time. Conclusions Findings suggest that this interactive comic series was successful in a resource limited setting at engaging simulation educators and helped to maintain their facilitation knowledge over time.

Interactive Digital Game for Improving Visual-Perceptual Defects in Children With a Developmental Disability: Randomized Controlled Trial.

BackgroundVisual–perceptual defects in children can negatively affect their ability to perform activities of daily living. Conventional rehabilitation training for correcting visual–perceptual defects has limited training patterns and limited interactivity, which makes motivation difficult to sustain.ObjectiveWe aimed to develop and evaluate an interactive digital game system for correcting visual–perceptual defects and evaluate its effectiveness.MethodsParticipants were children aged 5 to 10 years with a diagnosis of visual–perceptual defect associated with a developmental disability. The children were randomized into a digital game group who received the traditional course of rehabilitation combined with an interactive digital game intervention (n=12) and a standard rehabilitation group (n=11) who only received the traditional course of rehabilitation. Each group underwent rehabilitation once a week for 4 weeks. Overall improvement in Test of Visual Perceptual Skills 3rd edition (TVPS-3) score and overall improvement in performance in the interactive digital game were evaluated. Parents and therapists were asked to complete a satisfaction questionnaire.ResultsAfter 4 weeks, the TVPS-3 score had significantly increased (P=.002) in the digital game group (pre: mean 41.67, SD 13.88; post: 61.50, SD 21.64). In the standard rehabilitation group, the TVPS-3 score also increased, but the increase was not statistically significant (P=.58). Additionally, TVPS-3 score increases were significantly larger for the digital game group compared with those for the standard rehabilitation group (P=.005). Moreover, both parents and therapists were highly satisfied with the system. All 5 themes of satisfaction had mean scores higher than 4 in a 5-point scale questionnaire (mean 4.30, SD 0.56).ConclusionsThe system has potential applications for improving visual–perceptual function in children undergoing medical rehabilitation for developmental disability.Trial RegistrationClinicalTrials.gov NCT05016492; http://clinicaltrials.gov/ct2/show/NCT05016492

A multi-media digital intervention to improve the sexual and reproductive health of female adolescent emergency department patients.

Adolescent females presenting to emergency departments (EDs) inconsistently use contraceptives. We aimed to assess implementation outcomes and potential efficacy of a user-informed, theory-based digital health intervention developed to improve sexual and reproductive health for adolescent females in the ED. We conducted a pilot-randomized controlled trial of sexually active female ED patients age 14-19years. Participants were randomized to the intervention Dr. Erica (Emergency Room Interventions to improve the Care of Adolescents) or usual care. Dr. Erica consists of an ED-based digital intervention along with 3months of personalized and interactive multimedia messaging. We assessed the feasibility, adoption, and fidelity of Dr. Erica among adolescent female users. Initiation of highly effective contraception was the primary efficacy outcome. We enrolled 146 patients; mean (±SD) age was 17.7 (±1.27) years and 87% were Hispanic. Dr. Erica demonstrated feasibility, with high rates of consent (84.4%) and follow-up (82.9%). Intervention participants found Dr. Erica acceptable, liking (98.0%, on Likert scale) and recommending (83.7%) the program. A total of 87.5% adopted the program, responding to at least one text; a total of 289 weblinks were clicked. Dr. Erica demonstrated fidelity; few participants opted out (6.9%) and failed to receive texts (1.4%). Contraception was initiated by 24.6% (14/57) in the intervention and 21.9% (14/64) in the control arms (absolute risk difference [ARD]=2.7%, 95% confidence interval [CI]= -12.4% to 17.8%). Participants receiving Dr. Erica were more likely to choose a method to start in the future (65.9% [27/41]) than controls (30.0% [15/50]); ARD=35.9%, 95% CI= 16.6% to 55.1%). A personalized, interactive digital intervention was feasible to implement, acceptable to female ED patients and demonstrated high fidelity and adoption. This ED-based intervention shows potential to improve contraception decision making.

A Personalized, Interactive, Cognitive Behavioral Therapy-Based Digital Therapeutic (MODIA) for Adjunctive Treatment of Opioid Use Disorder: Development Study.

BackgroundOpioid use disorder (OUD) is characterized by the inability to control opioid use despite attempts to stop use and negative consequences to oneself and others. The burden of opioid misuse and OUD is a national crisis in the United States with substantial public health, social, and economic implications. Although medication-assisted treatment (MAT) has demonstrated efficacy in the management of OUD, access to effective counseling and psychosocial support is a limiting factor and a significant problem for many patients and physicians. Digital therapeutics are an innovative class of interventions that help prevent, manage, or treat diseases by delivering therapy using software programs. These applications can circumvent barriers to uptake, improve treatment adherence, and enable broad delivery of evidence-based management strategies to meet service gaps. However, few digital therapeutics specifically targeting OUD are available, and additional options are needed.ObjectiveTo this end, we describe the development of the novel digital therapeutic MODIA.MethodsMODIA was developed by an international, multidisciplinary team that aims to provide effective, accessible, and sustainable management for patients with OUD. Although MODIA is aligned with principles of cognitive behavioral therapy, it was not designed to present any 1 specific treatment and uses a broad range of evidence-based behavior change techniques drawn from cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing.ResultsMODIA uses proprietary software that dynamically tailors content to the users’ responses. The MODIA program comprises 24 modules or “chats” that patients are instructed to work through independently. Patient responses dictate subsequent content, creating a “simulated dialogue” experience between the patient and program. MODIA also includes brief motivational text messages that are sent regularly to prompt patients to use the program and help them transfer therapeutic techniques into their daily routines. Thus, MODIA offers individuals with OUD a custom-tailored, interactive digital psychotherapy intervention that maximizes the personal relevance and emotional impact of the interaction.ConclusionsAs part of a clinician-supervised MAT program, MODIA will allow more patients to begin psychotherapy concurrently with opioid maintenance treatment. We expect access to MODIA will improve the OUD management experience and provide sustainable positive outcomes for patients.

Leveraging Interdisciplinary Teams to Develop and Implement Secure Websites for Behavioral Research: Applied Tutorial.

Behavioral researchers are increasingly using interactive digital platforms, either as standalone or supplementary intervention tools, to facilitate positive changes in research participants’ health habits. Research-oriented interactive websites optimally offer a variety of participatory mediums, such as blogs, user-driven content, or health activities. Owing to the multidirectional features of interactive websites, and a corresponding need to protect research participants’ identity and data, it is paramount that researchers design ethical platforms that ensure privacy and minimize loss of anonymity and confidentiality. Authentication (ie, digital verification of one’s identity) of interactive sites is one viable solution to these concerns. Although previous publications have addressed ethical requirements related to authenticated platforms, few applied guidelines in the literature facilitate adherence to ethical principles and legally compliant study protocols during all phases of research website creation (feasibility, design, implementation, and maintenance). Notably, to remain compliant with ethical standards and study protocols, behavioral researchers must collaborate with interdisciplinary teams to ensure that the authenticated site remains secure and usable in all stages of the project. In this tutorial, we present a case study conducted at a large research university. Through iterative and practical recommendations, we detail lessons learned from collaborations with the Institutional Review Board, legal experts, and information technology teams. Although the intricacies of our applied tutorial may require adaptations based on each institution’s technological capacity, we are confident that the core takeaways are universal and thus useful to behavioral researchers creating ethically responsible and compliant interactive websites.

Evaluating an Interactive Digital Intervention for College Weight Gain Prevention

ObjectivePilot a digital interactive intervention for weight gain prevention among college students. MethodsOne sample pre-post study reporting on initial usability and changes in theoretical constructs (ie, self-efficacy, behavioral capability, elaboration) and program acceptability. Twenty college freshmen (mean age, 18.25 ± 0.72 years) reviewed a digital program providing self-assessment and brief tailored feedback on 8 behaviors that relate to a healthy weight: physical activity, sedentary behavior, and consumption of sugary beverages, high fat snacks, breakfast, fried foods, fruits and vegetables, and pizza. ResultsAt posttest, improvements in self-efficacy were found for 5 behaviors (ie, physical activity, high fat snacks, breakfast, fried foods, fruits and vegetables); improvements in behavioral capability were found for 3 behaviors (ie, high fat snacks, fried foods, and fruits and vegetables). Acceptability benchmarks included: positive impression (60%), relevance (95%), and ease of comprehension (75%). Conclusions and ImplicationsThis program demonstrates acceptability for a digital weight gain prevention intervention, with improvements in behavioral mediators of change. Suggestions to simplify messaging and allowing for user control may enhance acceptability and comprehension. There is a need for further testing with larger more diverse populations before broader implementation by universities to address student health.

The Sextherapylondon interactive website for sexual difficulties: content, design and rationale

Sexual difficulties are common, but there is limited access to specialist services. People concerned about their sexual functioning may not seek help, and patients and health professionals can find it difficult to raise the topic. This intervention description paper details the aims, design and therapeutic rationale underpinning an interactive website which provides stand-alone, tailored advice and self-help for sexual difficulties. Sextherapylondon (STL) is an interactive digital intervention (IDI) offering evidence-based sex therapy including psychoeducation, cognitive-behavioural and systemic therapy techniques within a social constructionist framework. An online triage module identifies those who need clinical assessment before proceeding with online sex therapy, generating a referral letter. STL offers online self-help for getting or keeping erections, early ejaculation, sexual pain, difficulties with orgasm, and lack or loss of sexual desire. In this paper we describe the content and design of the STL web-based sex therapy programs, including the theoretical and therapeutic rationale which underpins the website structure and content. Sextherapylondon replicates key aspects of therapist-delivered sex therapy from a range of theoretical approaches, to provide tailored, personalised feedback. By offering private, convenient online access, interactive digital interventions can address the needs of people with sexual difficulties who may not otherwise receive help.

An interactive website for informed contraception choice: randomised evaluation of Contraception Choices.

ObjectiveImproving use of effective contraception to prevent unintended pregnancy is a global priority, but misperceptions and concerns about contraception are common. Our objective was to evaluate an interactive website to aid informed choice of contraception.MethodsThe Contraception Choices website is an interactive digital intervention which offers tailored advice to aid contraception decision-making (www.contraceptionchoices.org). In a parallel single-blind trial, we randomised 927 women aged 15–30 years from six clinic settings to access the intervention website (n = 464) or to a waiting-list control group (n = 463). The study was initially a feasibility trial, evolving into an evaluation of efficacy, with two primary outcomes at six months: long-acting reversible contraception (LARC) use, and satisfaction with contraceptive method. Secondary outcomes included self-reported pregnancy and sexually transmitted infection diagnoses. Free-text comments on the 3 and 6 month outcome surveys were analysed thematically.FindingsThere was no significant difference between intervention and control groups in the proportion of women using LARC [30.4% intervention versus 31.0% control; adjusted odds ratio 0.87 (95% confidence interval 0.60 to 1.28)]; satisfaction with contraceptive method [82.6% versus 82.1%; adjusted ordinal odds ratio 0.93 (95% CI 0.69 to 1.25)]; self-reported pregnancy [3.3% versus 4.1%; adjusted odds ratio 0.90 (95% CI 0.45 to 1.79)] nor sexually transmitted infection [5.3% versus 4.7%; adjusted odds ratio 0.72 (95% CI 0.55 to 2.36)]. Highly positive free-text comments from intervention participants indicated that the website facilitates contraception choice and can help women feel better prepared before consultation with healthcare providers.InterpretationThe Contraception Choices website was popular for its design, trustworthy information and decision aids but it was not associated with significant differences in use of LARC or satisfaction with contraceptive method. An interactive website can aid contraception choice, but interventions that address factors beyond women’s control, such as access to services, and partner, family or community influences are needed to complement this approach.Research in contextPreventing unintended pregnancy through effective use of contraception is essential for women’s health, but choosing between different contraceptive methods can be challenging, and the opportunity for adequate discussion during routine consultations is often constrained.Evidence before this studyWe conducted two systematic literature reviews: 1) Factors influencing contraception choice, uptake and use: a meta-synthesis of systematic reviews; and 2) Effectiveness of interactive digital interventions (IDI) for contraception choice, uptake and use. For the first review we searched PubMed, CDSR, Epistemonikos, DoPHER, DARE, NHS Economic Evaluation Database, Campbell Library, NIHR Health Technology Assessment, and Health Evidence Canada databases for systematic reviews which addressed contraceptive choice, uptake or use, from 2000 to 2017. PROSPERO registration number: CRD42017081521 https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81521. We synthesised the findings of 18 systematic reviews of mostly moderate or high quality. They highlighted the importance of women’s knowledge, beliefs, perceptions of side effects and health risks, as well as relationship status, social network, economic and healthcare factors on contraception choice and use. For the second review, we searched 23 electronic databases, trials registers and reference lists for randomised controlled trials of IDI for contraception, including CENTRAL, MEDLINE, EMBASE, CINAHL, ERIC, ASSIA and PsycINFO, from start date to June 2017. PROSPERO registration number: CRD42017081636. We found only five randomised trials of IDI, all from the USA. Risk of bias prevented synthesis of results. www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=81636.Added value of this study Women’s common concerns about contraception – fear of hormones, weight gain, cancer, infertility, mood changes, breaks from contraception and changes in bleeding patterns – underpinned development of a new interactive website (www.contraceptionchoices.org). Contraception Choices addresses women’s concerns through succinct text; Q and A format (Frequently Asked Questions, Did you Know?; videos of women and health professionals); an effectiveness infographic, and an interactive decision aid (What’s right for me?).In an online randomised trial with 927 women attending clinics, we found no association of the Contraception Choices intervention with the primary outcomes – satisfaction with contraceptive method and uptake of long-acting reversible methods at 6 months. Nor did we find an association with secondary adverse outcomes – sexually transmitted infections or pregnancy. Comments from women indicated that the website can meet young women’s need for information on the benefits and drawbacks of contraception, help them to make informed decisions, and feel better prepared before healthcare consultations. Contraception Choices is now available on the NHS website: www.nhs.uk/conditions/contraception/which-method-suits-meImplications of all the available evidenceInteractive digital interventions (websites) can aid contraception choice, but other intervention research is needed to address wider influences on unintended pregnancy, including partner views, friends, family, the media, wider society and experiences with healthcare professionals. Future research could examine the impact of the website in different settings, e.g. schools or different countries. We hypothesise that use of the website during contraceptive consultations might improve the efficiency or quality of consultation, for both patients and healthcare providers. Appropriate methodology and time-scale for evaluating digital health interventions remains a key question.

Co-development of an interactive digital intervention to promote the well-being of people with intellectual disabilities

Digital technologies have great potential in offering interventions for people with intellectual disabilities. In this study, we aimed to co-develop a digital psycho-educational intervention, using a positive resource-oriented approach, to improve the mental well-being of people with intellectual disabilities. Using a two-phase design process, we first used a theory-guided approach to develop the content. Next, iterative consultations with an advisory group of people with and without intellectual disabilities were conducted to proceed with the digital design of the intervention. Feedback from the advisory group addressed issues regarding the intervention’s accessibility, interactivity, design and content. Changes were either implemented during the meetings or presented at consecutive meetings until the design and content were deemed satisfactory by the advisory group. This approach demonstrates that people with intellectual disabilities can be included in the development of a novel digital intervention. A future intervention study should determine the practicality and acceptability of this co-developed intervention in routine practice.

The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

This report details the development of the Men's Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation. (1) Develop the Men's Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men's views of online research methodology. (1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men's Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires. (1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men's Safer Sex website and technical problems were frustrating. Men's views of the Men's Safer Sex website and research procedures were largely positive. It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS. Current Controlled Trials ISRCTN18649610. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.

Digital health promotion in sexual health clinics: results of a feasibility trial of the Men’s Safer Sex website

Digital health promotion in sexual health clinics: results of a feasibility trial of the Men’s Safer Sex website

The Men's Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

ObjectivesWe aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men’s Safer Sex website, measuring condom use and sexually transmitted infection (STI).MethodsFor this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care (n = 84), or usual clinic care only (n = 75). Online outcome data were solicited at 3, 6, and 12 months.ResultsMen were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website (n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90).ConclusionIt is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings.Trial registration number: ISRCTN18649610

Digital Interventions to Promote Self-Management in Adults With Hypertension: Protocol for Systematic Review and Meta-Analysis.

BackgroundDigital interventions, defined as any intervention accessed and taking input from patients in the form of a computer/Web-based program or mobile phoned-based app, can potentially help empower patients to self-manage long-term conditions such as hypertension. Importantly, digital interventions have the potential to provide patients with personalized information and support for active involvement in treatment as well as cost saving.ObjectiveThe purpose of this systematic review is to synthesize the evidence for using digital interventions to support patient self-management of hypertension, and determine their impact on control and reduction of blood pressure, other clinical outcomes, quality of life, medication adherence, health service utilization, and economic benefits.MethodsA systematic search of bibliographic databases including Medline, Embase, CINAHL, and PsycINFO will be undertaken. s and citations will be independently screened by 2 researchers against predetermined inclusion criteria. Any disagreements will be resolved by discussion and further consideration of the inclusion criteria. Only randomized controlled trials which have been published in peer peer-reviewed journals with a diagnosis of hypertension will be considered. Inclusion criteria will be (1) adults (age ≥ 18 years) with hypertension (as defined by the primary authors); (2) an interactive digital intervention compared with usual care; and (3) outcomes of objectively measured change in blood pressure. Data extraction from identified articles will be undertaken by 2 independent reviewers using a uniform template. The main outcomes are systolic blood pressure (SBP) and diastolic blood pressure (DBP), and quality of life indicators. Secondary outcomes include cost- effectiveness, medication adherence, emotional well-being, and physical activity. Risk of bias of included studies will be assessed using the Cochrane tool.ResultsOur research is currently ongoing. Data will be summarized narratively, and if possible, meta-analyses will be performed to assess the impact of the interventions on outcomes.ConclusionsBy summarizing and synthesizing available data, this review will help inform policy on the use of digital interventions for self-management of hypertension and will clarify areas for further research.Trial RegistrationProspero 2014: CRD42014010268; http://www.crd.york.ac.uk/PROSPERO/display_record.asp? ID=CRD42014010268 (Archived by WebCite at http://www.webcitation.org/6c5alQQJL)

Increasing condom use in heterosexual men: development of a theory-based interactive digital intervention.

Increasing condom use to prevent sexually transmitted infections is a key public health goal. Interventions are more likely to be effective if they are theory- and evidence-based. The Behaviour Change Wheel (BCW) provides a framework for intervention development. To provide an example of how the BCW was used to develop an intervention to increase condom use in heterosexual men (the MenSS website), the steps of the BCW intervention development process were followed, incorporating evidence from the research literature and views of experts and the target population. Capability (e.g. knowledge) and motivation (e.g. beliefs about pleasure) were identified as important targets of the intervention. We devised ways to address each intervention target, including selecting interactive features and behaviour change techniques. The BCW provides a useful framework for integrating sources of evidence to inform intervention content and deciding which influences on behaviour to target.

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men

IntroductionSexually transmitted infections (STI) are a major public health problem. Condoms provide effective protection but there are many barriers to use. Face-to-face health promotion interventions are resource-intensive and show mixed...

Development of a theory-based interactive digital intervention to improve condom use in men in sexual health clinics: an application of qualitative methods using the behaviour change wheel

BackgroundEffective interventions for sexually transmitted infections (STIs) are more likely to have made extensive use of behaviour change theory and techniques and to have involved users in intervention design than those that are not effective; however, how to include theory in the design of behaviour change interventions is not clear. Recently, a framework for intervention has been developed that is a synthesis of the theoretical ideas depicted in 19 other frameworks (the behaviour change wheel [BCW]). The BCW defines behaviour change as requiring capability, opportunity, and motivation. These factors form the hub of the BCW around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these factors. We are developing a digital intervention to increase condom use in men in sexual health clinics, drawing on published work on barriers to condom use, behaviour change theory, and the views of men attending clinics to design the content and interactive features of the intervention. We present our experience of use of the BCW to incorporate these three sources of information into the design of a behaviour change intervention. MethodsInformation from three sources was combined: a review of the published work on barriers and facilitators to condom use; workshops with clinical and academic experts in sexual health; and semi-structured interviews with men attending sexual health clinics. This information was combined with use of the BCW framework to identify what theoretical domains needed to be targeted to change behaviour (eg, condom use skills, beliefs about consequences of behaviour) and how these should be targeted (eg, interactive features and behaviour change techniques). FindingsFindings from the review of publications and interviews with men affected the intervention content. Reduced pleasure was the most prominent barrier to condom use. Other barriers included absence of accurate knowledge about risk (eg, believing that one can make judgments about risk), and difficulty using condoms in “the heat of the moment”. The intervention was therefore designed to target these factors. Furthermore, published work suggests that many people make errors when using condoms, and so an activity training people in condom use was included. Men who were interviewed wanted information about STI symptoms and consequences, and so this was also included. Combining information from different sources is essential in designing a complex intervention; however, managing such a wealth of data can prove challenging. BCW helped to provide structure for this process, by sorting the findings into the categories set out by it. It was helpful in perceiving how each intervention target maps onto a theoretical domain and to guide decisions about how to prompt behaviour change. For example, inaccurate beliefs about ability to judge the risk of STIs is a psychological capability that we targeted by developing an interactive activity that depicts scenarios for asymptomatic chlamydia acquisition within a sexual network. This activity draws on the behaviour change techniques, including giving information about health consequences, comparative imagining of future outcomes, and vicarious consequences. InterpretationThe BCW provides a good starting point for intervention development and is a good framework for integration of information. The BCW integrates theoretical principles from multiple models of health behaviour, providing a systematic way of considering several influences on behaviour and planning the ways that an intervention may seek to change behaviour. Getting consensus between experts about which dimensions were most important was sometimes difficult. To overcome this limitation, we used data from the review of published work and the interviews to make informed decisions within the research team. FundingThis research was part of a wider project, which was funded by a NIHR Health Technology Assessment grant.