scholarly journals The effect of the Continuous Care Model on treatment adherence in patients with myocardial infarction: a randomised controlled trial

2020 ◽  
Vol 25 (1) ◽  
pp. 54-65
Author(s):  
Mohammad Ali Zakeri ◽  
Zohreh Khoshnood ◽  
Mahlagha Dehghan ◽  
Farokh Abazari
Keyword(s):  
Myocardial Infarction ◽  
Randomised Controlled Trial ◽  
Treatment Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Care Model ◽  
Continuous Care ◽  
Randomised Controlled

Background Adherence to treatment is one of the behaviours associated with successful outcomes following a myocardial infarction, which leads to successful treatment in the disease. Aims This study aimed to investigate the effect of the Continuous Care Model (CCM) on treatment adherence in patients with myocardial infarction. Methods This was a randomised controlled trial performed on 82 patients with myocardial infarction. Convenience sampling was used to select the participants, and then they were allocated into two groups by the stratified random method. In the intervention group, a CCM was implemented. In the intervention group, 4–6 educational sessions (1–2 h) were conducted during one month in the form of spoken questions and answers about the presented subjects. The control group received routine care. A questionnaire of demographic information and treatment adherence was completed by samples in the two groups, intervention and control, before and immediately after training and after follow-up. Results The results of this study showed that treatment adherence was significantly higher in the intervention group than in the control group immediately after training and after the follow-up phase (three months) ( p < 0.001). Also, diet, drug and physical activity adherence were significantly higher in the intervention group than in the control group immediately after training and after follow-up ( p < 0.001). Conclusions Implementation of CCM led to an increase in adherence to the treatment in patients with myocardial infarction. Therefore, it is suggested that this model could be used as a nursing intervention to increase treatment adherence in cardiac-rehabilitation programmes.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

scholarly journals Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037303
Author(s):  
Fumiya Tanji ◽  
Yasutake Tomata ◽  
Saho Abe ◽  
Sanae Matsuyama ◽  
Yumika Kotaki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Control Group ◽  
Intervention Period ◽  
The Mean ◽  
Randomised Controlled

ObjectiveThe aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.Study designTwo-arm, parallel-group randomised controlled trial.Setting/participantsWe recruited physically inactive community-dwelling adults from Sendai city, Japan. Eligible participants were randomly allocated to an intervention or a wait list control group. Pedometers were used to assess the mean number of daily steps in three periods: baseline (weeks 1–3), intervention (weeks 4–6) and follow-up (weeks 7–9).InterventionThe intervention group was offered a financial incentive (shopping points) to meet the target number of increased daily steps in the intervention period.Main outcome measuresThe primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.ResultsSeventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804) were randomised to the intervention (n=36) and control groups (n=36). During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311). In addition, compared with controls, a significantly higher proportion of participants in the intervention group showed an increase in mean daily steps of ≥1000 (69.4% vs 30.6%, respectively; OR=5.17, 95% CI=1.89 to 14.08). There were no adverse effects from the intervention.ConclusionsThe present results suggest that financial incentives are effective in promoting short-term increases in physical activity.Trial registration numberUMIN000033276.

scholarly journals Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated OA care model: Secondary analyses from a cluster-randomised controlled trial

2019 ◽  
Author(s):  
Tuva Moseng ◽  
Hanne Dagfinrud ◽  
Leti van Bodegom-Vos ◽  
Krysia Dziedzic ◽  
Kåre Birger Hagen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Structured Model ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract Background: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. Methods: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. Results: 284 intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR adjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. Conclusions: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.

Comparing audiometric parameters between crushed and intact cartilage tympanoplasty: a double-blinded, randomised, controlled trial study

2020 ◽  
pp. 1-5
Author(s):  
A Tajdini ◽  
N Hatami ◽  
B Rahmaty ◽  
A Kouhi ◽  
S Dabiri ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Hearing Results ◽  
Cartilage Tympanoplasty ◽  
One Year ◽  
Randomised Controlled ◽  
Double Blinded

Abstract Objective To investigate hearing and the take rate of crushed cartilage grafts in tympanoplasty. Methods In this double-blinded, randomised, controlled trial, 46 patients with tympanic membrane perforation were enrolled. A conchal cartilage graft was used for reconstruction in both intervention and control groups. In the intervention group, crushed cartilage was used. The success rate and hearing results were ascertained every four months over a one-year follow-up period. Results A total of 36 patients – 20 in the intervention group and 16 in the control group – completed one year of follow up. There were no statistically significant differences between the two groups in mean air–bone gap, bone conduction threshold, speech discrimination score or speech reception threshold. Conclusion The reduction in living cells after crushed cartilage tympanoplasty may decrease the rigidity and the volume of the graft, but may not necessarily improve the hearing results.

scholarly journals Evaluation of an Ultrasound-Guided Palpation Intervention for Palpation Skill Training: A Single-Blind, Parallel Group, Randomised Controlled Trial

2021 ◽  
Author(s):  
Takashi Kitagawa ◽  
Yuma Aoki ◽  
Hotaka Sugimoto ◽  
Natsumi Ozaki
Keyword(s):  
Medical Students ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Single Blind

Abstract Although there are increasing reports on the usefulness of sonopalpation with ultrasound imaging, many previous studies have reported interventions without a control group. This single-blind, parallel group randomised controlled trial aimed to determine whether educational instruction with sonopalpation for medical students has a superior effect on skill improvement than traditional instruction without ultrasonography. Twenty-nine medical students participated in the study and were randomised using block randomisation into an ultrasound imaging group (n = 15) and a control group (n = 14). Then, they underwent three training sessions focusing on the shoulder joint. Participants underwent a scoring assessment of their palpation skills at pre-intervention, post-intervention, and follow-up 3 months after training. The raters were blinded to the subjects’ group. The Friedman and Mann–Whitney U tests were used for data analysis. The intervention group showed a significant increase in scores at post-intervention and at the 3-month follow-up when compared with the pre-intervention group (p < 0.05); the effect sizes were large (0.849 and 0.849, respectively). A comparison of the scores at different time points after the intervention at the 3-month follow-up revealed that there was no significant difference between the groups. Education using ultrasound images may improve the sonopalpation skills of medical students.

scholarly journals Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial

2019 ◽  
Vol 217 (3) ◽  
pp. 477-483 ◽  
Author(s):  
Stefan Priebe ◽  
Agnes Chevalier ◽  
Thomas Hamborg ◽  
Eoin Golden ◽  
Michael King ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Social Isolation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Social Contacts ◽  
Significant Difference ◽  
Randomised Controlled

BackgroundBefriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.MethodPatients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.ResultsA total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI −40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.ConclusionsAlthough no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.

scholarly journals A Randomised Controlled Trial to Evaluate the Administration of the Health Improvement Card as a Health Promotion Tool: A Physiotherapist-Led Community-Based Initiative

2020 ◽  
Vol 17 (21) ◽  
pp. 8065
Author(s):  
Yiwen Bai ◽  
Xubo Wu ◽  
Raymond CC Tsang ◽  
Ruisheng Yun ◽  
Yan Lu ◽  
...  
Keyword(s):  
Health Promotion ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Health Improvement ◽  
Control Group ◽  
Lifestyle Practices ◽  
Randomised Controlled

A randomised controlled trial was conducted to evaluate the administration of the Health Improvement Card (HIC) on lifestyle practices and biometric variables in community-dwelling Chinese participants. Adults living in Shanghai were randomly assigned to either the HIC-intervention or control group. Measurements/assessments were conducted at baseline and three-month follow-up. Supervised physiotherapy students administered the HIC and four standardised questionnaires related to health and wellbeing. Both groups received a health promotion education pamphlet. Based on participants’ HIC biometric and lifestyle scores, students prescribed lifestyle, and exercise advice to the HIC-intervention group. 171 individuals (39 men, 132 women) (mean age 68.4 ± 9.7 y) participated. At follow-up, body mass index (BMI) and waist circumference decreased significantly in the HIC-intervention group. Furthermore, the number of participants in the HIC-intervention group categorised as low risk regarding their physical activity and dietary practices, increased by 32.2% and 20%, respectively. Changes in standardised questionnaire scores did not meet minimum clinically importance differences in either group. This is the first study to demonstrate that HIC-informed health promotion education can improve people’s lifestyle practices, thereby, objective biometric variables. Evaluation of the effect of HIC-informed lifestyle education on some biometric parameters (blood pressure and BMI) may warrant a longer timeframe.

scholarly journals A randomised controlled trial to reduce highest priority critically important antimicrobial prescription in companion animals

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
David A. Singleton ◽  
Angela Rayner ◽  
Bethaney Brant ◽  
Steven Smyth ◽  
Peter-John M. Noble ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Companion Animals ◽  
Intervention Group ◽  
Control Group ◽  
Prescription Data ◽  
Post Intervention ◽  
Electronic Prescription ◽  
Randomised Controlled

AbstractRobust evidence supporting strategies for companion animal antimicrobial stewardship is limited, despite frequent prescription of highest priority critically important antimicrobials (HPCIA). Here we describe a randomised controlled trial where electronic prescription data were utilised (August 2018–January 2019) to identify above average HPCIA-prescribing practices (n = 60), which were randomly assigned into a control group (CG) and two intervention groups. In March 2019, the light intervention group (LIG) and heavy intervention group (HIG) were notified of their above average status, and were provided with educational material (LIG, HIG), in-depth benchmarking (HIG), and follow-up meetings (HIG). Following notification, follow-up monitoring lasted for eight months (April–November 2019; post-intervention period) for all intervention groups, though HIG practices were able to access further support (i.e., follow-up meetings) for the first six of these months if requested. Post-intervention, in the HIG a 23.5% and 39.0% reduction in canine (0.5% of total consultations, 95% confidence interval, 0.4-0.6, P = 0.04) and feline (4.4%, 3.4-5.3, P < 0.001) HPCIA-prescribing consultations was observed, compared to the CG (dogs: 0.6%, 0.5-0.8; cats: 7.4%, 6.0-8.7). The LIG was associated with a 16.7% reduction in feline HPCIA prescription (6.1% of total consultations, 5.3-7.0, P = 0.03). Therefore, in this trial we have demonstrated effective strategies for reducing veterinary HPCIA prescription.

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals 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 ◽  
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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