scholarly journals Talking about premature ejaculation in primary care: the GET UP cluster randomised controlled trial

BJGP Open ◽  
2021 ◽  
pp. BJGPO.2021.0168
Author(s):  
Marie Barais ◽  
Marine Costa ◽  
Camille Montalvo ◽  
Vincent Rannou ◽  
Hélène Vaillant-Roussel ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Premature Ejaculation ◽  
Controlled Trial ◽  
Communication Strategies ◽  
Training Session ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

BackgroundPremature ejaculation is the most common sexual dysfunction in men. A previous qualitative study identified six communication strategies described by general practitioners (GP) to tackle this topic during consultations.AimTo determine whether these six strategies are more effective than usual care for promoting discussion about premature ejaculation by patients with their GP.Design and SettingCluster randomised controlled trial, stratified in four French regions, with an intervention group (GPs who received a training session on the six communication strategies) and a control group (routine medical care). Participants were 18-80-year-old men consulting for a sexual, urogenital or psychological reason.MethodThe efficacy of the training session in communication skills, compared with usual care, was evaluated by determining the percentage of patients who discussed premature ejaculation with their GP (primary outcome). The percentage of enrolled patients with premature ejaculation was calculated using as cut-off a score >9 of the Premature Ejaculation Diagnostic Tool filled in by the enrolled patients at week four after the consultation. The quality-of-life changes were evaluated as the SF-12 scale score difference between baseline and week four post-consultation.Results130 patients were included by 32 GPs (n=16 in the intervention and n=16 in the control group). The percentage of patients who discussed about premature ejaculation was higher in the intervention than in the control group (42% vs. 4.9%, absolute difference = 37% 95%CI [24% to 50%], p <0.001).ConclusionsTraining GPs in communication strategies about premature ejaculation improves its detection.ClinicalTrials.govNCT02378779, date of registration: 03/02/2015.

scholarly journals An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Audrey Rankin ◽  
◽  
Cathal A. Cadogan ◽  
Heather E. Barry ◽  
Evie Gardner ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Older People ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Video ◽  
Link Type ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background The use of multiple medications (polypharmacy) is a concern in older people (≥65 years) and is associated with negative health outcomes. For older populations with multimorbidity, polypharmacy is the reality and the key challenge is ensuring appropriate polypharmacy (as opposed to inappropriate polypharmacy). This external pilot cluster randomised controlled trial (cRCT) aims to further test a theory-based intervention to improve appropriate polypharmacy in older people in primary care in two jurisdictions, Northern Ireland (NI) and the Republic of Ireland (ROI). Methods Twelve GP practices across NI (n=6) and the six counties in the ROI that border NI will be randomised to either the intervention or usual care group. Members of the research team have developed an intervention to improve appropriate polypharmacy in older people in primary care using the Theoretical Domains Framework of behaviour change. The intervention consists of two components: (1) an online video which demonstrates how a GP may prescribe appropriate polypharmacy during a consultation with an older patient and (2) a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. Ten older patients receiving polypharmacy (≥4 medications) will be recruited per GP practice (n=120). GP practices allocated to the intervention arm will be asked to watch the online video and schedule medication reviews with patients on two occasions; an initial and a 6-month follow-up appointment. GP practices allocated to the control arm will continue to provide usual care to patients. The study will assess the feasibility of recruitment, retention and study procedures including collecting data on medication appropriateness (from GP records), quality of life and health service use (i.e. hospitalisations). An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention and potential mechanisms of action. Discussion This pilot cRCT will provide evidence of the feasibility of a range of study parameters such as recruitment and retention, data collection procedures and the acceptability of the intervention. Pre-specified progression criteria will also be used to determine whether or not to proceed to a definitive cRCT. Trial registration ISRCTN, ISRCTN41009897. Registered 19 November 2019. ClinicalTrials.gov, NCT04181879. Registered 02 December 2019.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Severin Haug ◽  
Raquel Paz Castro ◽  
Andreas Wenger ◽  
Michael P. Schaub
Keyword(s):  
Randomised Controlled Trial ◽  
Cigarette Smoking ◽  
Internet Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Addiction Prevention ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

scholarly journals Interdisciplinary COPD intervention in primary care: a cluster randomised controlled trial

2019 ◽  
Vol 53 (4) ◽  
pp. 1801530 ◽  
Author(s):  
Jenifer Liang ◽  
Michael J. Abramson ◽  
Grant Russell ◽  
Anne E. Holland ◽  
Nicholas A. Zwar ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Lung Function ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Smoking Abstinence ◽  
Model Of Care ◽  
Cluster Randomised ◽  
Randomised Controlled

We evaluated the effectiveness of an interdisciplinary, primary care-based model of care for chronic obstructive pulmonary disease (COPD).A cluster randomised controlled trial was conducted in 43 general practices in Australia. Adults with a history of smoking and/or COPD, aged ≥40 years with two or more clinic visits in the previous year were enrolled following spirometric confirmation of COPD. The model of care comprised smoking cessation support, home medicines review (HMR) and home-based pulmonary rehabilitation (HomeBase). Main outcomes included changes in St George's Respiratory Questionnaire (SGRQ) score, COPD Assessment Test (CAT), dyspnoea, smoking abstinence and lung function at 6 and 12 months.We identified 272 participants with COPD (157 intervention, 115 usual care); 49 (31%) out of 157 completed both HMR and HomeBase. Intention-to-treat analysis showed no statistically significant difference in change in SGRQ at 6 months (adjusted between-group difference 2.45 favouring intervention, 95% CI –0.89–5.79). Per protocol analyses showed clinically and statistically significant improvements in SGRQ in those receiving the full intervention compared to usual care (difference 5.22, 95% CI 0.19–10.25). No statistically significant differences were observed in change in CAT, dyspnoea, smoking abstinence or lung function.No significant evidence was found for the effectiveness of this interdisciplinary model of care for COPD in primary care over usual care. Low uptake was a limitation.

scholarly journals Effects of a kindergarten intervention on vegetables served and staff’s food-related practices: results of a cluster randomised controlled trial – the BRA study

2020 ◽  
Vol 23 (6) ◽  
pp. 1117-1126
Author(s):  
Anne Himberg-Sundet ◽  
Anne Lene Kristiansen ◽  
Lene Frost Andersen ◽  
Mona Bjelland ◽  
Nanna Lien
Keyword(s):  
Randomised Controlled Trial ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Public And Private ◽  
Cluster Randomised ◽  
Block Randomisation ◽  
Randomised Controlled

AbstractObjective:The aim of the current study was to evaluate the effect on frequency, variety and amount of vegetables served and staff’s food-related practices in the multicomponent BRA intervention.Design:Cluster randomised controlled trial, conducted between Spring 2015 and Spring 2016. For allocation of the kindergartens, a stratified block randomisation was used. Data were collected in three ways: (i) a questionnaire for pedagogical leaders assessing the variety and frequency of vegetables served, including staff’s food-related practices assumed to be related to vegetable intake; (ii) a questionnaire for kindergarten assistants assessing staff’s food-related practices; (iii) a 5-d weighted vegetable diary assessing amount of vegetables served in a department.Setting:The target group for this study was public and private kindergartens in the counties of Vestfold and Buskerud, Norway.Participants:A total of seventy-three kindergartens participated.Results:At follow-up I, the amount of vegetables served increased by approximately 20 g per person per day (P = 0·002), and the variety in served vegetables increased by one-and-a-half kind per month (P = 0·014) in the intervention group compared to the control group. No effects on the frequency of vegetables served or on staff’s food-related practices were found.Conclusions:The BRA intervention was successful in increasing the amount and variety of vegetables served within intervention kindergartens. Further research is needed to understand the mechanisms that can affect the staff’s food-related practices.

scholarly journals Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028427 ◽  
Author(s):  
Charilaos Lygidakis ◽  
Jean Paul Uwizihiwe ◽  
Per Kallestrup ◽  
Michela Bia ◽  
Jeanine Condo ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Integrated Management ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Chronic Patients ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionIn Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients’ health behaviours and HBCPs’ work satisfaction.Methods and analysisThis is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs’ programme; (2) HBCPs’ programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs’ programme. Under each hospital, administrative areas implementing the HBCPs’ programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs’ programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.Ethics and disseminationEthics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT03376607; Pre-results.

scholarly journals Cluster randomised controlled trial of an online intervention to prevent ecstasy and new psychoactive substance use among adolescents: final results and implications for implementation

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e020433 ◽  
Author(s):  
Katrina E Champion ◽  
Nicola Clare Newton ◽  
Lexine Stapinski ◽  
Maree Teesson
Keyword(s):  
Randomised Controlled Trial ◽  
Health Education ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Online Intervention ◽  
Control Group ◽  
Full Dose ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

ObjectivesTo evaluate the effectiveness of the onlineClimate Schools: Ecstasy and Emerging Drugs moduleover 2 years, and examine the impact of intervention dose on outcomes.DesignCluster randomised controlled trial.SettingSecondary schools in Australia.Participants1126 students (aged 14.9 years) from 11 schools.InterventionFive schools were randomly allocated to the four-lesson internet-basedClimate Schools: Ecstasy and Emerging Drugsmodule. This universal intervention uses cartoon storylines to deliver harm-minimisation information about ecstasy and new psychoactive substances (NPS). It was delivered during health education classes over 4 weeks. Six schools were randomised to the control group (health education as usual). Participants were not blinded to intervention allocation.Outcomes measuresStudents completed self-report surveys at baseline, post-test, 6, 12 and 24 months post-baseline. Intentions to use ecstasy and NPS (including synthetic cannabis and synthetic stimulants), knowledge about ecstasy and NPS and lifetime use of ecstasy and NPS were assessed. This paper reports the results at 24 months post-baseline.AnalysisMixed effects regressions were conducted to analyse intervention effects from baseline to 24 months. Post hoc analyses using Inverse Probability of Treatment Weighting compared controls with students who: i) completed all four lessons (‘full dose’) and ii) partially completed the intervention (≤three lessons, ‘incomplete dose’).ResultsPrimary analyses found that controls were significantly more likely to intend on using synthetic cannabis compared with intervention group students (OR=3.56, p=0.01). Results from the weighted analyses indicated that controls reported significantly lower knowledge about ecstasy (p=0.001) and NPS (p=0.04) compared with the full-dose group. No significant differences were observed between the incomplete dose and control groups.ConclusionsThe online intervention was effective in modifying students’ intentions to use synthetic cannabis up to 24 months; however, this study highlights the importance of delivering prevention programmes in full to maximise student outcomes.Trial registration numberACTRN12613000708752.

A Smartphone App in Promoting Mental Wellbeing and Awareness of Anxiety Disorders for Adolescents: A Pilot Cluster Randomised Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Yuying Sun ◽  
Man Ping Wang ◽  
Sai Yin Ho ◽  
Christian S. Chan ◽  
Patrick K.W. Man ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Anxiety Disorders ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Mental Wellbeing ◽  
Smartphone App ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

BACKGROUND Mental health problems in adolescents are prevalent while population-based interventions for improving mental wellbeing of adolescents are limited. OBJECTIVE To design a smartphone app and evaluate its effect on promoting mental wellbeing of adolescents and awareness of anxiety disorders. METHODS A pilot cluster randomised controlled trial was conducted with 2 secondary schools (390 students, mean age 13.1 years) randomised to the intervention and control groups. A smartphone app was designed for one month’s use to promote mental wellbeing through “Sharing, Mind and Enjoyment (SME)” related interactions between students and their parents (e.g., express gratitude to family in words or actions), with assistance of App designers in releasing SME tasks daily. The waitlist control group was offered the app after completing all assessments. The primary outcomes were SME behaviours measured at 3-month after baseline. Secondary outcomes included subjective happiness, wellbeing, personal health and happiness, family health, happiness and harmony, self-perceived knowledge and understanding of anxiety disorders. Two focus groups of students and three individual in-depth interviews of service providers were conducted. RESULTS In the intervention students, 11.2% used the app together with parents and 45.4% used it without involving parents. The intervention group did not show significant difference in the change of SME behaviours at 1-month or 3-month compared with the control group. The intervention group showed greater increase in the awareness of anxiety disorders at follow-ups than the control group (Cohen’s d=0.52 at 1-month and 0.43 at 3-month, both P<0.001). Post-hoc analysis showed significantly greater increase in SME-related behaviours in the adherent subgroup than the control group at 3-month (d=0.46, P=0.04). The interviews found favourable changes in app users, but motivation of using the app was low in general. Both students and community partners suggested primary school students would be more receptive users. CONCLUSIONS The app did not show effectiveness in increasing SME behaviours of students but was effective in increasing awareness of anxiety disorders. Further improvements and tests among younger children and their parents are warranted. CLINICALTRIAL ClinicalTrials.gov NCT03361475

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