Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU)

IntroductionCompression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise.Methods and analysisThe Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective.Ethics and disseminationThe Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page.Trial registration numbersAustralia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).</jats:sec

Recruiting equal numbers of indigenous and non-indigenous participants to a ‘polypill’ randomized trial

Introduction. Māori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Māori and non-Māori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a "polypill") improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Māori as non-Māori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this. Methods. Experienced Māori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Māori researchers and was committed to equal recruitment of Māori and non-Māori. Additional funding and Māori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Māori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Māori were targeted, with over-sampling of potentially eligible Māori patients, lower thresholds for screening of Māori and 6 months continued Māori recruitment after non-Māori recruitment had finished. Results: A total of 257 Māori and 256 non-Māori participants were randomized. Four Māori and eight non-Māori participants were randomized per research nurse per month. Potentially eligible Māori were more likely than non-Māori to proceed to subsequent stages of recruitment. Differences between randomized Māori and non-Māori were evident (e.g. Maori were less likely to have established coronary artery disease). Conclusions: Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported. Trial registration. The trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572. © 2013 Selak et al.; licensee BioMed Central Ltd

Evaluation of MyTeen – a SMS-based mobile intervention for parents of adolescents: a randomised controlled trial protocol

Abstract Background Parents play an important role in the lives of adolescents and efforts aimed at strengthening parenting skills and increasing knowledge on adolescent development hold much promise to prevent and mitigate adolescent mental health problems. Innovative interventions that make use of technology-based platforms might be an effective and efficient way to deliver such support to parents. This protocol presents the design of a randomised controlled trial to investigate the effectiveness of a SMS-based mobile intervention (MyTeen) for parents of adolescents on promoting parental competence and mental health literacy. Methods A parallel two-arm randomised controlled trial will be conducted in New Zealand, aiming to recruit 214 parents or primary caregivers of adolescents aged 10–15 years via community outreach and social media. Eligible participants will be allocated 1:1 into the control or the intervention group, stratified by ethnicity. The intervention group will receive a tailored programme of text messages aimed at improving their parental competence and mental health literacy, over 4 weeks. The control group (care-as-usual) will receive no intervention from the research team, but can access alternative services if they wish, and will be offered the intervention programme upon completion of a 3-month post-randomisation follow-up assessment. Data will be obtained at baseline, post intervention (1-month), and 3-month follow up. The primary outcome is parental competence assessed by the Parental Sense of Competence Scale at 1-month follow up. Secondary outcomes include: mental health literacy; knowledge of help-seeking; parental distress; parent-adolescent communication; and programme satisfaction. Discussion To our knowledge this is the first randomised controlled trial on the effectiveness of delivering a parenting support intervention for parents of adolescents solely via a SMS-based mobile intervention. If effective, it could have great potential to reach and support parents of adolescents. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN12618000117213) Registered on 29/01/2018

See How They Grow: Testing the feasibility of a mobile app to support parents' understanding of child growth charts.

BackgroundMobile devices provide new opportunities for the prevention of overweight and obesity in children. We aimed to co-create and test an app that offered comprehensible feedback to parents on their child's growth and delivered a suite of age-specific information about nutrition and activity.MethodsA two-phased approach was used to co-create the digital growth tool-See How They Grow-and test its feasibility. Phase one used focus groups (parents and professionals such as paediatricians and midwives) and a national on-line survey to gather requirements and build the app. Phase two involved testing the app over 12-weeks, with parents or carers of children aged ≤ 2-years. All research activities were undertaken exclusively through the app, and participants were recruited using social media and hard copy materials given to patents at a child health visit.FindingsFour focus groups and 101 responses to the national survey informed the features and functions to include in the final app. Two hundred and twenty-five participants downloaded the app, resulting in 208 eligible participants. Non-Māori/Non-Pacific (78%) and Māori (14%) had the highest downloads. Fifty-four per cent of participants were parents of children under 6-months. These participants were more likely to regularly use the app than those with children older than 6-months (64% vs 36%, P = 0.011). Over half of the participants entered three measures (n = 101, 48%). Of those that completed the follow-up survey (n = 101, 48%), 72 reported that the app helped them better understand how to interpret growth charts.ConclusionThe app was acceptable and with minor modifications, has the potential to be an effective tool to support parents understanding of growth trajectories for their children. A larger trial is needed to evaluate if the app can have a measurable impact on increasing knowledge and behaviour, and therefore on preventing childhood overweight and obesity

The impact of a point-of-care testing device on CVD risk assessment completion in New Zealand primary-care practice: A cluster randomised controlled trial and qualitative investigation

<div><p>Objectives</p><p>To assess the effect of a point of care (POC) device for testing lipids and HbA_1c in addition to testing by community laboratory facilities (usual practice) on the completion of cardiovascular disease (CVD) risk assessments in general practice.</p><p>Methods</p><p>We conducted a pragmatic, cluster randomised controlled trial in 20 New Zealand general practices stratified by size and rurality and randomised to POC device plus usual practice or usual practice alone (controls). Patients aged 35–79 years were eligible if they met national guideline criteria for CVD risk assessment. Data on CVD risk assessments were aggregated using a web-based decision support programme common to each practice. Data entered into the on-line CVD risk assessment form could be saved pending blood test results. The primary outcome was the proportion of completed CVD risk assessments. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and questionnaire. The POC testing was supported by a comprehensive quality assurance programme.</p><p>Results</p><p>A CVD risk assessment entry was recorded for 7421 patients in 10 POC practices and 6217 patients in 10 control practices; 99.5% of CVD risk assessments had complete data in both groups (adjusted odds ratio 1.02 [95%CI 0.61–1.69]). There were major external influences that affected the trial: including a national performance target for CVD risk assessment and changes to CVD guidelines. All practices had invested in systems and dedicated staff time to identify and follow up patients to completion. However, the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussions. Shortly after commencement, the trial was halted due to a change in the HbA_1c test assay performance. The trial restarted after the manufacturing issue was rectified but this affected the end use of the device.</p><p>Conclusions</p><p>Performance incentives and external influences were more powerful modifiers of practice behaviours than the POC device in relation to CVD risk assessment completion. The promise of combining risk assessment, communication and management within one consultation was not realised. With shifts in policy focus, the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting.</p><p>Trial registration</p><p>Australian New Zealand Clinical Trials Registry <a target="_blank">ACTRN12613000607774</a></p></div

Consort diagram of participation.

<p>Consort diagram of participation.</p

Data completion in CVD risk assessments in the 12 months post randomisation.

<p>Data completion in CVD risk assessments in the 12 months post randomisation.</p

Characteristics of patients who had an on-line CVD risk assessment form opened in the 8 months before and after 12 months commencement of the trial.

<p>Characteristics of patients who had an on-line CVD risk assessment form opened in the 8 months before and after 12 months commencement of the trial.</p