scholarly journals One year later: Highlighting the challenges and opportunities in disseminating a breathing-retraining digital behaviour change intervention

2020 ◽  
Vol 6 ◽  
pp. 205520762093644
Author(s):  
Ben Ainsworth ◽  
Anne Bruton ◽  
Mike Thomas ◽  
Lucy Yardley
Keyword(s):  
Behaviour Change ◽  
Large Scale ◽  
Digital Health ◽  
Low Cost ◽  
Controlled Trial ◽  
Cost Effective ◽  
Challenges And Opportunities ◽  
Breathing Retraining ◽  
One Year ◽  
Randomised Controlled

Digital behaviour change interventions can provide effective and cost-effective treatments for a range of health conditions. However, after rigorous evaluation, there still remain challenges to disseminating and implementing evidence-based interventions that can hinder their effectiveness ‘in the real world’. We conducted a large-scale randomised controlled trial of self-guided breathing retraining, which we then disseminated freely as a digital intervention. Here we share our experience of this process after one year, highlighting the opportunities that digital health interventions can offer alongside the challenges that must be addressed in order to harness their effectiveness. Whilst such treatments can support many individuals at extremely low cost, careful dissemination strategies should be proactively planned in order to ensure such opportunities are maximised and interventions remain up to date in a fast-moving digital landscape.

scholarly journals The Feasibility of a Strategy for the Remote Recruitment, Consenting and Assessment of Recent Referrals: A Protocol for Phase 1 of the on-line Parent Training for the Initial Management of ADHD Referrals (OPTIMA).

2021 ◽  
Author(s):  
Katarzyna Kostyrka-Allchorne ◽  
Claire Ballard ◽  
Sarah Byford ◽  
Samuele Cortese ◽  
David Daley ◽  
...  
Keyword(s):  
Data Collection ◽  
Parent Training ◽  
Large Scale ◽  
Low Cost ◽  
Controlled Trial ◽  
Phase 1 ◽  
Online Data ◽  
Parenting Support ◽  
Disruptive Behaviours ◽  
Randomised Controlled

Abstract Background: In the UK, children with high levels of hyperactivity, impulsivity and inattention referred to clinical services with possible attention-deficit/hyperactivity disorder (ADHD) often wait a long time for specialist diagnostic assessment. Parent training (PT) has the potential to support parents during this difficult period, especially regarding the management of challenging and disruptive behaviours that often accompany ADHD. However, traditional face-to-face PT is costly and difficult to organise in a timely way. We have created a low-cost, easily accessible PT programme delivered via a phone app, Structured E-Parenting Support (STEPS), to address this problem. The overall OPTIMA programme will evaluate the efficacy and cost-effectiveness of STEPS as a way of helping parents manage their children behaviour while on the waiting list. To ensure the timely and efficient evaluation of STEPS in OPTIMA, we have worked with children’s health services to implement a remote strategy for recruitment, screening, and assessment of recently referred families. Part of this strategy is incorporated into routine clinical practice and part is OPTIMA specific. Here we present the protocol for Phase 1 of OPTIMA – a study of the feasibility of this remote strategy, as a basis for a large-scale STEPS randomised controlled trial (RCT). Methods: This is a single arm observational feasibility study. Parents of up to 100 children aged 5-11 years with high levels of hyperactivity/impulsivity, inattention and challenging behaviour who are waiting for assessment in one of five UK child and adolescent mental health or behavioural services. Recruitment, consenting and data collection will occur remotely. The primary outcome will be the rate at which the families, who meet inclusion criteria, agree in principle to take part in a full STEPS RCT. Secondary outcomes include acceptability of remote consenting and online data collection procedures; the feasibility of collecting teacher data remotely within the required timeframe, and technical difficulties with completing online questionnaires. All parents in the study will receive access to STEPS. Discussion: Establishing the feasibility of our remote recruitment, consenting and assessment strategy is a pre-requisite for the full trial of OPTIMA. It can also provide a model for future trials conducted remotely. Trial registration: N/A

scholarly journals The Feasibility of Health Trainer Improved Patient Self-Management in Patients with Low Health Literacy and Poorly Controlled Diabetes: A Pilot Randomised Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-11 ◽  
Author(s):  
Joanne Protheroe ◽  
Trishna Rathod ◽  
Bernadette Bartlam ◽  
Gillian Rowlands ◽  
Gerry Richardson ◽  
...  
Keyword(s):  
Health Literacy ◽  
Usual Care ◽  
Low Cost ◽  
Controlled Trial ◽  
Illness Perception ◽  
Cost Effective ◽  
Outcome Data ◽  
Disadvantaged Population ◽  
Low Health Literacy ◽  
Randomised Controlled

Type 2 diabetes mellitus is most prevalent in deprived communities and patients with low health literacy have worse glycaemic control and higher rates of diabetic complications. However, recruitment from this patient population into intervention trials is highly challenging. We conducted a study to explore the feasibility of recruitment and to assess the effect of a lay health trainer intervention, in patients with low health literacy and poorly controlled diabetes from a socioeconomically disadvantaged population, compared with usual care. Methods. A pilot RCT comparing the LHT intervention with usual care. Patients with HbA1c > 7.5 (58 mmol/mol) were recruited. Baseline and 7-month outcome data were entered directly onto a laptop to reduce patient burden. Results. 76 patients were recruited; 60.5% had low health literacy and 75% were from the most deprived areas of England. Participants in the LHT arm had significantly improved mental health (p=0.049) and illness perception (p=0.040). The intervention was associated with lower resource use, better patient self-care management, and better QALY profile at 7-month follow-up. Conclusion. This study describes successful recruitment strategies for hard-to-reach populations. Further research is warranted for this cost-effective, relatively low-cost intervention for a population currently suffering a disproportionate burden of diabetes, to demonstrate its sustained impact on treatment effects, health, and health inequalities.

scholarly journals The feasibility of a strategy for the remote recruitment, consenting and assessment of recent referrals: a protocol for phase 1 of the On-Line Parent Training for the Initial Management of ADHD referrals (OPTIMA)

2022 ◽  
Vol 8 (1) ◽  
Author(s):  
Katarzyna Kostyrka-Allchorne ◽  
Claire Ballard ◽  
Sarah Byford ◽  
Samuele Cortese ◽  
David Daley ◽  
...  
Keyword(s):  
Data Collection ◽  
Parent Training ◽  
Large Scale ◽  
Low Cost ◽  
Controlled Trial ◽  
Phase 1 ◽  
Online Data ◽  
Parenting Support ◽  
Disruptive Behaviours ◽  
Randomised Controlled

Abstract Background In the UK, children with high levels of hyperactivity, impulsivity and inattention referred to clinical services with possible attention-deficit/hyperactivity disorder (ADHD) often wait a long time for specialist diagnostic assessment. Parent training (PT) has the potential to support parents during this difficult period, especially regarding the management of challenging and disruptive behaviours that often accompany ADHD. However, traditional face-to-face PT is costly and difficult to organise in a timely way. We have created a low-cost, easily accessible PT programme delivered via a phone app, Structured E-Parenting Support (STEPS), to address this problem. The overall OPTIMA programme will evaluate the efficacy and cost-effectiveness of STEPS as a way of helping parents manage their children behaviour while on the waitlist. To ensure the timely and efficient evaluation of STEPS in OPTIMA, we have worked with children’s health services to implement a remote strategy for recruitment, screening and assessment of recently referred families. Part of this strategy is incorporated into routine clinical practice and part is OPTIMA specific. Here, we present the protocol for Phase 1 of OPTIMA—a study of the feasibility of this remote strategy, as a basis for a large-scale STEPS randomised controlled trial (RCT). Methods This is a single arm observational feasibility study. Participants will be parents of up to 100 children aged 5-11 years with high levels of hyperactivity/impulsivity, inattention and challenging behaviour who are waiting for assessment in one of five UK child and adolescent mental health or behavioural services. Recruitment, consenting and data collection will occur remotely. The primary outcome will be the rate at which the families, who meet inclusion criteria, agree in principle to take part in a full STEPS RCT. Secondary outcomes include acceptability of remote consenting and online data collection procedures; the feasibility of collecting teacher data remotely within the required timeframe, and technical difficulties with completing online questionnaires. All parents in the study will receive access to STEPS. Discussion Establishing the feasibility of our remote recruitment, consenting and assessment strategy is a pre-requisite for the full trial of OPTIMA. It can also provide a model for future trials conducted remotely.

scholarly journals Metformin reduces 12-month change in body weight among people newly commenced on clozapine: a retrospective naturalistic cohort study

2021 ◽  
Vol 11 ◽  
pp. 204512532110006
Author(s):  
Jessica Spokes ◽  
Samantha Hollingworth ◽  
Karl Winckel ◽  
Steve Kisely ◽  
Andrea Baker ◽  
...  
Keyword(s):  
Cohort Study ◽  
Weight Gain ◽  
Tobacco Smoking ◽  
Digital Health ◽  
Controlled Trial ◽  
Bodyweight Gain ◽  
Metabolic Effects ◽  
Secondary Outcome ◽  
Standard Clinical Practice ◽  
Randomised Controlled

Background: People with schizophrenia have a 15–20-year reduction in life expectancy, driven in part by the metabolic effects of antipsychotics. Clozapine is associated with the highest rates of weight gain. As clozapine remains the most effective antipsychotic for treatment-resistant schizophrenia (TRS), identifying treatments to ameliorate clozapine-induced weight gain (CIWG) is urgently needed to reduce this morality gap. Methods: We retrospectively analysed digital health records of patients with TRS aged 18–65 newly initiated on clozapine at four tertiary hospitals in south-east Queensland from 1 March 2017 to 30 June 2019. Our primary outcome was the effect of metformin on change in percentage bodyweight at 12 months after clozapine initiation, with secondary outcome being proportion with >5% or >7% bodyweight change. We also explored impact on bodyweight change of other variables including sex, tobacco smoking, type 2 diabetes (T2DM), age, clozapine level and dose and clozapine/norclozapine ratio. Results: Among 90 patients initiated on clozapine, metformin use ( n = 48) was associated with a smaller increase in percentage bodyweight (1.32% versus 5.95%, p = 0.031), lower rates of >7% gain in bodyweight (37.8% versus 63.0%, p = 0.025) but not >5% gain in bodyweight. Age below the median (32.0 years) was associated with greater bodyweight gain (5.55% versus 1.22%, p = 0.046). Sex, tobacco smoking, T2DM, clozapine dose and level and clozapine/norclozapine ratio were not associated with differences in change in bodyweight. Conclusion: In this small retrospective cohort study, use of metformin within 12-months of clozapine initiation was associated with a statistically and clinically significant reduction in CIWG. Although there is increasing evidence for the role of metformin to ameliorate bodyweight gain at time of clozapine initiation, our findings need replication and testing in a randomised controlled trial before recommending metformin co-commencement with clozapine as standard clinical practice.

Low‐cost local food supplements could improve maternal and birth outcomes in Indonesia: A pilot randomised controlled trial

2021 ◽  
Vol 46 (3) ◽  
pp. 321-331
Author(s):  
Kun A. Susiloretni ◽  
Dyah Nur Subandriani ◽  
Elisa Ulfiana ◽  
Sunarto Sunarto ◽  
Trina Astuti ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Birth Outcomes ◽  
Local Food ◽  
Low Cost ◽  
Controlled Trial ◽  
Food Supplements ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

scholarly journals Can we rely on non-randomised studies? Findings from a meta-epidemiological review

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
J C Rejon-Parrilla ◽  
M Salcher-Konrad ◽  
M Nguyen ◽  
K Davis ◽  
P Jonsson ◽  
...  
Keyword(s):  
Health Economic ◽  
Analytical Methods ◽  
Large Scale ◽  
Treatment Effects ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Risk Of Bias ◽  
Economic Decision Making ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background Increasingly, health technology assessment (HTA) agencies must decide whether new medicines should be used routinely in the absence of randomised controlled trial (RCT) data, relying solely on non-randomised studies (NRS), which are at high risk of bias due to confounding. Against the background of increased availability and improved methods to analyse non-randomised data (e.g., propensity score methods and instrumental variables), it is important for decision-makers to have guidance on the analysis and interpretation of NRS to inform health economic evaluation. We therefore aimed to systematically and empirically assess the performance of NRS using different analytical methods as compared to RCTs and develop recommendations on the basis of our findings. Methods We conducted a large-scale meta-epidemiological review to obtain estimates of the discrepancy in treatment effects in matched RCTs and NRS of pharmacologic interventions from published meta-analyses indexed in MEDLINE and the Cochrane Database of Systematic Reviews. We also consulted with HTA bodies, regulators and academics from five European countries to learn from their experience with using non-randomised evidence. Results We compiled the largest dataset of clinical topics with matching RCTs and NRS using various analytical methods to date, covering >100 unique clinical questions. Incorporating information on direction of effect and effect size from >700 unique studies, the dataset can be used to evaluate discrepancies in treatment effects between study designs across a wide range of therapeutic areas. Conclusions An empirically based understanding of the risk of bias in NRS is required in order to promote the adequate use of non-randomised evidence as input for health economic decision-making.

scholarly journals Effects of a workplace prevention programme for problem gambling: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015963 ◽  
Author(s):  
Jonas Rafi ◽  
Ekaterina Ivanova ◽  
Alexander Rozental ◽  
Per Carlbring
Keyword(s):  
Problem Gambling ◽  
Large Scale ◽  
Controlled Trial ◽  
Public Health Problem ◽  
Cluster Randomised Controlled Trial ◽  
Severity Index ◽  
The Body ◽  
Prevention Programme ◽  
Open Access Journals ◽  
Randomised Controlled

IntroductionDespite being considered a public health problem, no prevention programme for problem gambling in workplace settings has been scientifically evaluated. This study aims to fill a critical gap in the field of problem gambling by implementing and evaluating a large-scale prevention programme in organisations.Methods and analysisTen organisations, with a total of n=549 managers and n=8572 employees, will be randomised to either receiving a prevention programme or to a waitlist control condition. Measurements will be collected at the baseline and 3, 12 and 24 months after intervention. The primary outcome of interest is the managers’ inclination to act when worried or suspicious about an employee’s problem gambling or other harmful use. Additional outcomes of interest include the Problem Gambling Severity Index and gambling habits in both managers and employees. Furthermore, qualitative analyses of the responses from semistructured interviews with managers will be performed.Ethics and disseminationThis study has been approved by the regional ethics board of Stockholm, Sweden, and it will contribute to the body of knowledge concerning prevention of problem gambling. The findings will be published in peer-reviewed, open-access journals.Trial registration numberNCT02925286; Pre-results.

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