scholarly journals Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Judith Bek ◽  
Melanie R. Brown ◽  
Jagjeet Jutley-Neilson ◽  
Nicholas C. C. Russell ◽  
Pia A. J. Huber ◽  
...  
Keyword(s):  
Local Community ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Control Group ◽  
Stroke Survivors ◽  
Baseline Assessment ◽  
Timed Up And Go ◽  
Waiting Period ◽  
Randomised Controlled

Background.Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy.Methods.Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale.Results.Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs.) and were randomised. 70 commenced the intervention (n=37) or an equivalent waiting period (n=33). 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events.Discussion.Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review.Conclusion.A definitive trial is feasible. This trial is registered withISRCTN84064492.

scholarly journals Interprofessional medication assessment among home care patients: any impact on functioning? Results from a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
K. Auvinen ◽  
A. Voutilainen ◽  
J. Jyrkkä ◽  
E. Lönnroos ◽  
P. Mäntyselkä
Keyword(s):  
Home Care ◽  
Activities Of Daily Living ◽  
Usual Care ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Care Group ◽  
Timed Up And Go ◽  
Randomised Controlled

Abstract Background Multimorbidity and polypharmacy are related to the use of potentially inappropriate medicines and negative clinical outcomes including drug-related adverse events and functional declines. Home care clients are a vulnerable patient group often exposed to these risks. The aim of this study was to examine whether an interprofessional medication assessment can influence the functioning of home care patients. Methods The FIMA study was a randomised controlled intervention study comparing a general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up. We used linear mixed models (LMM) with a random subject effect to detect differences between the usual care and intervention groups in the following outcome measures; Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D. Results Home care patients (n = 512) had major disease burdens and functional limitations. Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 s worsening in the usual care group. However, the result was not statistically significant. The ADL revealed an interaction across time, treatment and sex (p = 0.026). The ADL score decreased in both groups; the decline being the steepest among women in the intervention group. Conclusions In general, medication assessments may have limited impact on functioning of older people. Nonetheless, the FIMA intervention may prevent worsening of mobility among older home care patients. Trial registration The Interprofessional Medication Assessment for Older Patients, Clinical Trials.gov. NCT02398812. First registration, 26 March 2015. Retrospectively registered.

scholarly journals Effectiveness of a Single Education and Counseling Intervention in Reducing Anxiety in Women Undergoing Hysterosalpingography: A Randomized Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Alfredo La Fianza ◽  
Carolina Dellafiore ◽  
Daniele Travaini ◽  
Davide Broglia ◽  
Francesca Gambini ◽  
...  
Keyword(s):  
Ad Hoc ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Control Group ◽  
Counseling Intervention ◽  
Self Rating ◽  
Before And After ◽  
Randomised Controlled ◽  
Infertility Patients

Hysterosalpingography (HSG) is generally considered a stressful and painful procedure; we aimed to evaluate whether a single education and counseling intervention could reduce women’s distress and pain after undergoing HSG for infertility. Patients were randomized into control group (n=108) and intervention group (n=109). All patients filled the following questionnaires before and after HSG: Zung self-rating anxiety scale (Z-SAS), Zung self-rating depression scale (Z-SDS), and an ad hoc questionnaire designed to evaluate HSG procedure knowledge. Pain was scored using a visual analog scale. The intervention consisted in a 45-minute individualised session 48 h before HSG. We observed a reduction of anxiety and depression scores in the intervention arm compared to the control group. After controlling for potential confounding variables, intervention was an independent predictor of the difference of Z-SAS score before and after HSG. This is the first randomised controlled trial to assess the potential effectiveness of a single education and counseling intervention to lower anxiety in a diagnostic setting.

scholarly journals Interprofessional medication assessment among home care patients: Any impact on functioning? Results from a randomised controlled trial

2020 ◽  
Author(s):  
Kati Johanna Auvinen ◽  
Ari Voutilainen ◽  
Johanna Jyrkkä ◽  
Eija Lönnroos ◽  
Pekka Mäntyselkä
Keyword(s):  
Home Care ◽  
Activities Of Daily Living ◽  
Usual Care ◽  
Daily Living ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Care Group ◽  
Timed Up And Go ◽  
Randomised Controlled

Abstract Background Multimorbidity and polypharmacy are related to the use of potentially inappropriate medicines and negative clinical outcomes including drug-related adverse events and functional declines. Home care clients are a vulnerable patient group often exposed to these risks. The aim of this study was to examine whether an interprofessional medication assessment can influence the functioning of home care patients.Methods The FIMA study was a randomised controlled intervention study comparing a general practitioner-led interprofessional medication assessment conducted at the baseline of the study with usual care with a six-month follow-up. We used linear mixed models (LMM) with a random subject effect to detect differences between the usual care and intervention groups in the following outcome measures; Katz index of Activities of Daily Living (ADL), Lawton and Brody scale of Instrumental Activities of Daily Living, Timed up and go-test (TUG), Mini-Mental State Examination, Geriatric Depression Scale and the 3-level version of EQ-5D. Results Home care patients (n= 512) had major disease burdens and functional limitations. Regarding TUG times, the LMM detected a one second improvement in the FIMA group and 2.4 seconds worsening in the usual care group. However, the result was not statistically significant. The ADL revealed an interaction across time, treatment and sex (p=0.026). The ADL score decreased in both groups; the decline being the steepest among women in the intervention group. Conclusions In general, medication assessments may have limited impact on functioning of older people. Nonetheless, the FIMA intervention may prevent worsening of mobility among older home care patients. Trial registration The Interprofessional Medication Assessment for Older Patients, Clinical Trials.gov. NCT02398812. First registration, 26 March 2015. Retrospectively registered. https://www.clinicaltrials.gov/ct2/show/NCT02398812

scholarly journals Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040108
Author(s):  
Rowan W Johnson ◽  
Sian A Williams ◽  
Daniel F Gucciardi ◽  
Natasha Bear ◽  
Noula Gibson
Keyword(s):  
Exercise Prescription ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Programme ◽  
Home Exercise ◽  
Control Group ◽  
Neurodevelopmental Disabilities ◽  
Home Exercise Programme ◽  
Exercise Programmes ◽  
Randomised Controlled

ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.

scholarly journals A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. A. Greidanus ◽  
A. E. de Rijk ◽  
A. G. E. M. de Boer ◽  
M. E. M. M. Bos ◽  
P. W. Plaisier ◽  
...  
Keyword(s):  
Return To Work ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Work Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Secondary Effect ◽  
Quality Of Working Life ◽  
Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

scholarly journals Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e026086
Author(s):  
Yasutake Tomata ◽  
Fumiya Tanji ◽  
Dieta Nurrika ◽  
Yingxu Liu ◽  
Saho Abe ◽  
...  
Keyword(s):  
Financial Incentives ◽  
Primary Outcome ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Intervention Group ◽  
Sample Size Calculation ◽  
Community Dwelling ◽  
Control Group ◽  
Modifiable Factors ◽  
Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

Effect of Communication Skills Training Program for Oncologists Based on Patient Preferences for Communication When Receiving Bad News: A Randomized Controlled Trial

2014 ◽  
Vol 32 (20) ◽  
pp. 2166-2172 ◽  
Author(s):  
Maiko Fujimori ◽  
Yuki Shirai ◽  
Mariko Asai ◽  
Kaoru Kubota ◽  
Noriyuki Katsumata ◽  
...  
Keyword(s):  
Communication Skills ◽  
Patient Preferences ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Skills Training ◽  
Control Group ◽  
Communication Skills Training ◽  
Communication Performance

Purpose The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists' communication. Participants and Methods Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation. Results At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists' style of communication. Conclusion A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills.

scholarly journals Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Charlotte Loumann Krogh ◽  
Charlotte Ringsted ◽  
Charles B. Kromann ◽  
Maria Birkvad Rasmussen ◽  
Tobias Todsen ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Global Rating ◽  
Training Performance ◽  
Significant Difference ◽  
Training Format ◽  
Peer Performance ◽  
And Performance ◽  
Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Hatem Hussein El-Gamal ◽  
Walid El-Basuony Mohammad ◽  
Ahmed Samir Mohamed Zeerban
Keyword(s):  
Quality Of Life ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Expectant Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Caesarean Scar Defect ◽  
Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

Effectiveness of balance training programme in reducing the frequency of falling in established osteoporotic women: a randomized controlled trial

2016 ◽  
Vol 31 (2) ◽  
pp. 217-224 ◽  
Author(s):  
Ibolya Mikó ◽  
Imre Szerb ◽  
Anna Szerb ◽  
Gyula Poor
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Balance Training ◽  
Training Programme ◽  
Exercise Programme ◽  
Berg Balance Scale ◽  
Control Group ◽  
Timed Up And Go ◽  
Randomized Controlled

Objective: To investigate the effect of a 12-month sensomotor balance exercise programme on postural control and the frequency of falling in women with established osteoporosis. Design: Randomized controlled trial where the intervention group was assigned the 12-month Balance Training Programme and the control group did not undertake any intervention beyond regular osteoporosis treatment. Subjects: A total of 100 osteoporotic women – at least with one osteoporotic fracture – aged 65 years old and above. Main measures: Balance was assessed in static and dynamic posture both with performance-based measures of balance, such as the Berg Balance Scale and the Timed Up and Go Test, and with a stabilometric computerized platform. Interventions: Patients in the intervention group completed the 12-month sensomotor Balance Training Programme in an outpatient setting, guided by physical therapists, three times a week, for 30 minutes. Results: The Berg Balance Scale and the Timed Up and Go Test showed a statistically significant improvement of balance in the intervention group ( p = 0.001 and p = 0.005, respectively). Balance tests using the stabilometer also showed a statistically significant improvement in static and dynamic postural balance for osteoporotic women after the completion of the Balance Training Programme. As a consequence, the one-year exercise programme significantly decreased the number of falls in the exercise group compared with the control group. Conclusion: The Balance Training Programme significantly improved the balance parameters and reduced the number of falls in postmenopausal women who have already had at least one fracture in the past.

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