scholarly journals Does self-initiated sit-to-stand training with an assistive device regain the independence of sit-to-stand in stroke patient? A single-blinded randomized controlled trial

2020 ◽  
Vol 7 ◽  
pp. 205566831986605
Author(s):  
Ng Chee Man Joey ◽  
Woo Ka Ho Marc
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Assistive Device ◽  
Control Group ◽  
Stroke Survivors ◽  
Stand Test ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Hemiparetic Stroke

Background It is unknown whether self-initiated sit-to-stand training with an assistive device is effective to regain the independence of sit-to-stand in stroke survivors. Objective To compare the effectiveness of self-initiated sit-to-stand training with an assistive device with manual sit-to-stand training. Design Parallel randomized controlled, assessor-blinded trial between January 2015 and May 2018. Randomization was performed by drawing lots to allocate treatment groups. Setting A rehabilitation hospital in Hong Kong. Participants 69 participants in medical wards with unilateral hemiparetic stroke. A total of 52 participants fulfilled the study requirements. Intervention Ten sessions of intervention with conventional physiotherapy program followed, by self-initiated sit-to-stand training with an assistive device, or by manual sit-to-stand training. Main outcome measure Number of participants regained the independence of sit-to-stand, sit-to-stand test from the Balance master® and Five-repetition sit-to-stand test. Results 69 participants (intervention, n = 36; control, n = 33) were randomized (mean age, 69.8 years (SD: 10.6), mean post-stroke days 18.6 (SD: 16.0)). Seventeen participants had not completed 10 sessions of training, leaving 52 ( n = 26; n = 26) participants for per protocol analysis. Eighteen participants in the intervention group and 10 participants in the control group had regained the independence of sit-to-stand (Phi and Cramer’s V: –0.31 and 0.31). The participants in the intervention group were faster to complete the Five-repetition sit-to-stand test than the control group (32.7 sec (SD: 1.93) versus 48.4 sec (SD, 6.8); 95% confidence interval, –30.8 to –0.7; p < 0.05). No adverse side effects occurred during and after the training across groups. Conclusions Self-initiated sit-to-stand training with an assistive device may have positive effects on speeding up regaining the independence of sit-to-stand on sub-acute stroke survivors.

scholarly journals Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Thomas Timmers ◽  
Loes Janssen ◽  
Yvette Pronk ◽  
Babette C van der Zwaard ◽  
Sander Koëter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Knowledge ◽  
Actual Knowledge ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

scholarly journals Effectiveness of a Two-Tier Family-Oriented Intervention in Enhancing Family Functioning and Care Capacity of Family Caregivers of Stoke Survivors: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Vivian Weiqun Lou ◽  
Jennifer Yee Man Tang ◽  
Gary Kui Kai Lau ◽  
Terry Yat Sang Lum ◽  
Kenneth Fong ◽  
...  
Keyword(s):  
Family Functioning ◽  
Family Caregivers ◽  
Controlled Trial ◽  
Management Strategies ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Stroke Survivors ◽  
Randomized Controlled ◽  
Care Capacity

BACKGROUND Stroke brings about abrupt and immense changes to stroke families’ dynamics and responsibilities. Adaptation to new family roles is challenging, as support for caregivers of stoke survivors is minimal, presenting a major obstacle towards restoring family functioning and maximizing care capacity. OBJECTIVE This study aims to implement and examine the effectiveness of a two-tier family- oriented intervention involving care managers and volunteers for enhancing family functioning and care capacity of family caregivers of stroke survivors. METHODS This is a multicenter, two-armed, randomized, controlled study (intervention group, n=150; control group, n=150). Following case referral from hospital, family caregivers of stroke survivors and stroke survivors provide informed consent and undergo initial screening. Caregivers report significant caregiver burden, and/or depressive mood, and/or family dysfunctioning are randomly assigned to undergo two-tier family-oriented intervention (intervention group) or psychoeducation (control group). The primary outcome is the change in i) family role performance, ii) family caregiver conflict, iii) care management strategies, and iv) general family functioning from baseline to 2 weeks and 2 months after completion of intervention. RESULTS This study began in January 2017 and is being conducted at three participating facilities in Hong Kong. CONCLUSIONS This study will examine the effectiveness of a two-tier family- oriented intervention in enhancing family functioning and care capacity of family caregivers of stroke survivors. Through this study, we expect that this intervention can fill the service gap in the current stroke care system and serves as an important basis on which future evidence-based programs supporting family caregivers of stroke survivors could develop. CLINICALTRIAL ClinicalTrials.gov NCT03034330; https://ichgcp.net/clinical-trials-registry/NCT03034330

Impact of the WHO depression guideline on patient care by psychiatrists: A randomized controlled trial

2008 ◽  
Vol 23 (6) ◽  
pp. 403-408 ◽  
Author(s):  
Michel Linden ◽  
Anja Westram ◽  
Lutz G. Schmidt ◽  
Clemenz Haag
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Training Group ◽  
Control Group ◽  
Negative Effects ◽  
Course Of Illness ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Information Group

AbstractBackgroundScientific literature reviews aim to summarize the state of knowledge and published empirical evidence. In contrast, medical guidelines are intervention tools that aim to improve physician behaviour and patient outcome. They can have positive effects, but they can also have negative effects. Their effects must be tested by research.MethodsIn a randomized controlled trial, 103 psychiatrists in private practice were either provided with the WHO depression guideline only (information group), or provided with the WHO depression guideline and trained for one day in this guideline (intervention group), or left uninformed (control group). They then treated a total of 497 patients according to individual clinical considerations and the needs of the patients. Observation of routine treatment lasted 12 weeks. Physicians and patients documented the course of illness and treatment, including the patient–physician interaction.ResultsPsychiatrists in the intervention group saw more psychosocial stressors in their patients, prescribed higher dosages of medication, had fewer drop-outs, and rated treatment outcome as better. The ratings of patient–physician interactions indicated more strain in their relationships.ConclusionsThe results show both positive and negative effects of guideline exposure, but only in the training group and not in the information group. Guidelines should be empirically tested before being called “evidence based”. Every guideline should also explain how it can or must be implemented in order to become effective.

scholarly journals Safer cycling in older age (SiFAr): a protocol of a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hanna Maria Siebentritt ◽  
Veronika Keppner ◽  
Sabine Britting ◽  
Robert Kob ◽  
Anja Rappl ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Dwelling ◽  
Older Age ◽  
Control Group ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Cycling has positive effects on health and the proportion of older cyclists is rising. However, the risk for older adults to be injured or killed by a bicycle accident increases. The aim of the ongoing project “Safer Cycling in Older Age (SiFAr)” is to promote safer cycling in community-dwelling older adults with a structured, multi-component exercise training. Methods SiFAr is a randomized, controlled trial with a duration of 3 months for the intervention and a 6–9 months follow-up. We address community-dwelling persons aged 65 years and older living in the area Nürnberg-Fürth-Erlangen (Germany) who are either 1) beginners with the e-bike or 2) feeling self-reported unsteadiness when cycling or 3) uptaking cycling after a longer break. Long-term, experienced cyclists without subjectively reported limitations or worries when cycling are excluded. Participants are either randomized 1:1 to an intervention group (IG; receiving multi-component exercise program related to cycling, MEPC) or an active control group (aCG; receiving health and bicycle-related presentations, HRP). The purpose of this study is to investigate if the cycling competence of the IG will improve compared to the aCG. The cycling competence as primary outcome is tested not blinded in a standardized cycle course prior and after the intervention period, which consists of variant tasks requiring motor and cognitive skills related to traffic situations in daily life. Additional assessments such as physical functioning, quality of life, fear of falling, questionnaires regarding cycling behavior are obtained. To investigate the primary objective, regression analyses with difference of errors in the cycling course as independent variable and group as dichotomous dependent variable adjusted for covariates (sex, bicycle type) will be performed. The trial design is described in the present manuscript, using the extended CONSORT checklist for reporting pragmatic trials. Discussion Since there is a lack of cycling-related interventions for older people, SiFAr aims to evaluate a standardized intervention to enhance cycling safety. The results of the SiFAr trial could contribute to the implementation of an evaluated cycling course concept promoting mobility and independence of older adults. Trial registration This study was registered with clinicaltrials.gov: NCT04362514 on April 27, 2020

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Effectiveness of Text Messaging as an Incentive to Maintain Physical Activity after Cardiac Rehabilitation: A Randomized Controlled Pilot Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6645
Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cardiac Rehabilitation ◽  
Exercise Testing ◽  
Text Messages ◽  
Control Group ◽  
Stand Test ◽  
Randomized Controlled ◽  
Sit To Stand ◽  
Significant Difference

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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