A Randomised Controlled Trial Comparing the Effect of E-learning, with a Taught Workshop, on the Knowledge and Search Skills of Health Professionals

Objective - The aim of the trial was to establish whether there is a significant difference in terms of knowledge and skills, between self-directed learning using a web-based resource, compared with a classroom based interactive workshop, for teaching health professionals how to search. The outcomes measured were knowledge of databases and study designs, and search skills. Methods - The study design was a randomised controlled trial (RCT). 17 health professionals were randomised into one of two groups – one group (EG) received access to a search-skills web resource, and the other group received a search workshop (WG) taught by a librarian. Participants completed pre- and post-intervention tests involving multiple choice questions and practical searching using clinical scenarios.. Results - 9 WG and 6 EG participants completed both pre-and post-intervention tests. The test results were blindly marked using a score chart developed with two other librarians. For question formulation and devising a search strategy, all participants obtained a score that was the same or better after receiving the intervention (both WG and EG), but statistical analysis showed that the only significant outcomes were for the WG devising a search strategy (p=0.01) and preferring to search using MeSH after receiving the taught workshop (p=0.02). The Mann-Whitney test showed there were no significant differences in any of the outcomes (p>0.05), between the WG and the EG. The statistical analyses must be viewed with caution due to the small sample size. Conclusions - There were no significant differences in knowledge of databases and study design, or search skills, when the WG and the EG were compared. Although many participants obtained a score that was higher post-intervention, only devising a search strategy and preferring to search using MeSH were significant for the WG. The question of whether a taught workshop and an e-learning module are of equal effectiveness in teaching search skills, is an important one for health librarians involved in user education, and was a justifiable topic to propose and conduct research. The fact that the results are mainly inconclusive due to the small sample size is disappointing, but does not diminish the importance of conducting the study.

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Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

ERJ Open Research ◽

10.1183/23120541.00460-2020 ◽

2020 ◽

Vol 6 (4) ◽

pp. 00460-2020

Author(s):

Michael G. Crooks ◽

Jack Elkes ◽

William Storrar ◽

Kay Roy ◽

Mal North ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Small Sample Size ◽

Controlled Trial ◽

Small Sample ◽

Self Management ◽

Open Label ◽

Management Interventions ◽

Randomised Controlled ◽

The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

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Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol

BMJ Open ◽

10.1136/bmjopen-2020-039852 ◽

2020 ◽

Vol 10 (12) ◽

pp. e039852

Author(s):

Ingunn Mundal ◽

Rolf W Gråwe ◽

Hege Hafstad ◽

Carlos De las Cuevas ◽

Mariela Loreto Lara-Cabrera

Keyword(s):

Randomised Controlled Trial ◽

Sample Size ◽

Controlled Trial ◽

Well Being ◽

Educational Programme ◽

Parental Engagement ◽

Control Group ◽

Post Intervention ◽

Randomised Controlled ◽

Parent Activation

IntroductionSignificant numbers of children with attention deficit hyperactivity disorder (ADHD) display problems that cause multiple disabilities, deficits and handicaps that interfere with social relationships, development and school achievement. They may have multiple problems, which strain family dynamics and influence the child’s treatment. Parent activation, described as parents’ knowledge, skills and confidence in dealing with their child’s health and healthcare, has been shown to be an important factor in improving health outcomes. Research suggests that parents need edification to learn skills crucial to the treatment and management of their children’s healthcare. Promoting positive parenting techniques may reduce negative parenting factors in families. This study aims to assess the acceptability, feasibility and estimated sample size of a randomised controlled trial (RCT) comparing an ADHD peer co-led educational programme added to treatment as usual (TAU).Methods and analysisUsing a randomised waitlist controlled trial, parents of children aged 6–12 years newly diagnosed with ADHD, and referred to a child mental health outpatient clinic in Mid-Norway, will receive TAU concomitant with a peer co-facilitated parental engagement educational programme (n=25). Parents in the control group will receive TAU, and the educational programme treatment within a waitlist period of 3–6 months (n=25). Parent activation, satisfaction, well-being, quality of life and treatment adherence, will be assessed at baseline (T0), 2 weeks (T1) pre–post intervention (T2, T3) and at 3 months follow-up (T4). Shared decision making, parents preferred role in health-related decisions and involvement, parent-reported symptoms of ADHD and child’s overall level of functioning will be assessed at T0 and T4. Such data will be used to calculate the required sample size for a full-scale RCT.Ethics and disseminationApproval was obtained from the Regional Committee for Medicine and Health Research Ethics in Mid-Norway (ref: 2018/1196). The findings of this study are expected to provide valuable knowledge about how to optimise family education and management of ADHD and will be disseminated through presentations at conferences and publication in peer-reviewed journals.Trial registration numberNCT04010851.

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Health professionals� attitudes towards and experiences with a culture-sensitive smartphone application for women with gestational diabetes mellitus in a randomised controlled trial: a qualitative study.

10.2196/preprints.9686.a ◽

2017 ◽

Author(s):

Lisa Garnweidner-Holme ◽

Therese Hoel Andersen ◽

Mari Wastvedt Sando ◽

Josef Noll ◽

Mirjam Lukasse

Keyword(s):

Diabetes Mellitus ◽

Randomised Controlled Trial ◽

Qualitative Study ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Health Professionals ◽

Controlled Trial ◽

Smartphone Application ◽

Randomised Controlled

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A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-050661 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050661

Author(s):

Håvard Kallestad ◽

Simen Saksvik ◽

Øystein Vedaa ◽

Knut Langsrud ◽

Gunnar Morken ◽

...

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Patient Education ◽

Cognitive Behavioural Therapy ◽

Controlled Trial ◽

Behavioural Therapy ◽

Group Differences ◽

Post Intervention ◽

Cognitive Behavioural ◽

Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial.

10.21203/rs.3.rs-47586/v2 ◽

2021 ◽

Author(s):

Parvati Rose Perman-Howe ◽

Emma L Davies ◽

David R Foxcroft

Keyword(s):

Randomised Controlled Trial ◽

Alcohol Consumption ◽

Sample Size ◽

Study Protocol ◽

Controlled Trial ◽

Pilot Trial ◽

Recruitment Rate ◽

Participant Recruitment ◽

Licensed Premises ◽

Randomised Controlled

Abstract Background Reducing the alcohol content of drinks has the potential to reduce alcohol consumption. Aims: (1) test the feasibility of a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption within licensed premises in the United Kingdom (UK), (2) provide data to estimate key parameters for a RCT. Methods Double-blind randomised controlled cross-over pilot trial based within four licensed premises in the UK. Participants (n=36) purchased and consumed ad libitum a 3.5% lager and a 4.8% lager during two separate study sessions. Descriptive statistics reported the efficacy and efficiency of the study processes, and the rates of licensed premises recruitment, and participant recruitment and attrition. Mean and the 95% confidence interval (CI) compared alcohol consumption between conditions. The mean, standard deviation (SD) and CI of UK units of alcohol consumed were used to calculate a sample size for a RCT. Responses to participant questionnaires and duration of participation in study sessions between conditions were analysed.Results Components of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated. The participant recruitment rate was greater than anticipated. The rate of attrition was 23% and varied by less than 1% according to the arm of the trial. There was a reduction of alcohol consumed under the intervention conditions. Estimated mean difference, and 95% CI (UK units): -3.76 (-5.01 to -2.52).The sample size required for a RCT is 53. Participants did not find one lager more pleasant in taste: (on a scale of one to 10) -0.95 (-2.11 to 0.21). Participants found the reduced-strength lager less enjoyable: (on a scale of one to 10) -1.44 (-2.64 to -0.24) and they perceived themselves to be less intoxicated after consuming it: (on a scale of one to 10) -1.00 (-1.61 to -0.40).Conclusion A RCT is feasible with minor alterations to the study protocol and scoping work to establish different brands of alcohol that are more alike and more enjoyable than the products used in the pilot trial. Trial registration Registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017: https://www.socialscienceregistry.org/trials/2266. Unique identifying number: AEARCTR-0002266.

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A randomised controlled trial to investigate the effectiveness of sustained photoprotective behaviour in xeroderma pigmentosum after intervention

BJPsych Open ◽

10.1192/bjo.2021.764 ◽

2021 ◽

Vol 7 (S1) ◽

pp. S287-S287

Author(s):

Tamara Searle ◽

Jessica Walburn ◽

Sam Norton

Keyword(s):

Randomised Controlled Trial ◽

Self Efficacy ◽

Xeroderma Pigmentosum ◽

Controlled Trial ◽

Premalignant Lesions ◽

Mental Wellbeing ◽

Group Effect ◽

Post Intervention ◽

Randomised Controlled

AimsThis study aimed to investigate whether an intervention designed to improve photoprotective behaviours is effective at changing behaviour and whether any change could be maintained.BackgroundXeroderma Pigmentosum (XP) is a rare condition in which patients are at risk of malignancies when exposed to ultra-violet radiation (UVR). Sufferers must take extra precautions to protect themselves from UVR. They must apply sunscreen to exposed skin, wear thick clothing, gloves, and a UVR-protective visor. Treatments include preventative photoprotective measures; the use of sunscreen and protective clothing. Additionally, frequent eye and skin examinations are required and swift removal of any premalignant lesions.MethodIn this randomised controlled trial, 16 participants with XP were given questionnaires at 4 time points; baseline, post-intervention, 5 months and 9 months post-intervention. The intervention involved 7 one-on-one counselling sessions, as well as telephone consultations. Counselling sessions encouraged photoprotection adherence, self-efficacy and discussions of any barriers to improving photoprotective behaviour. This study focused on psychosocial variables, attitudes and photoprotection. Questionnaires included the photoprotection self-efficacy questionnaire, Self-Reported Behavioural Automaticity Index, Short Warwick-Edinburgh Mental Wellbeing Scale, Quality of Life and Brief Photoprotection Adherence Questionnaire.ResultThe intervention was shown to have no significant effect on participants’ questionnaires scores. Univariate ANCOVA revealed a group effect between follow-up 1 (FU1) and follow-up 2 (FU2); η2 = 0.422 for self-efficacy in wearing photoprotective clothing. A group effect was identified from BL to FU1 and FU1 to FU2; η2 = 0.343 and η2 = 0.378 respectively in how often participants reapplied sunscreen to their face when outside for longer periods. Univariate ANCOVA revealed no group or time effect for the other outcome variables; for example, sunscreen self-efficacy.ConclusionThe intervention had no significant effect on photoprotective behaviour questionnaire scores. Future research could focus on recruiting more participants globally to generate more statistically powered results. Research should focus on producing a maintainable intervention so that any positive change would produce better long-term health outcomes. This study lays the foundations for future XP research, which will be vital to improve understanding and enhance photo protective behaviour.

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