scholarly journals Does a bespoke education session change levels of catastrophizing, kinesiophobia and pain beliefs in patients with patellofemoral pain? A feasibility study

2021 ◽  
pp. 1-11
Author(s):  
Jonathan James ◽  
James Selfe ◽  
Peter Goodwin
Keyword(s):  
Feasibility Study ◽  
Future Study ◽  
Pain Catastrophizing ◽  
Controlled Trial ◽  
Patellofemoral Pain ◽  
Control Group ◽  
Education Session ◽  
Pain Beliefs ◽  
Patient Reported ◽  
The Impact

OBJECTIVES: To assess the feasibility of a 30-minute education session for patients with patellofemoral pain on levels of catastrophizing and kinesiophobia. DESIGN: Randomised feasibility study SETTING: Three sites within a single NHS Organisation in England. PARTICIPANTS: Thirty-one adult patients were screened for inclusion, resulting in twenty-four who had a clinical diagnosis of patellofemoral pain being randomised equally to either the intervention or control group. INTERVENTION: Participants were randomised to either control or intervention conditions; both received standardized physiotherapy while the intervention/experimental group received a 30-minute educational session addressing causes of pain, beliefs about noise that comes from the joint, the impact of the pain on activity, the influence of other family members’ experience and beliefs about knee pain. Intervention participants were also given an education leaflet: ‘Managing My Patellofemoral Pain’. MAIN OUTCOMES: recruitment, retention, intervention fidelity. Patient reported outcome measures (PROMs): Knee injury and Osteoarthritis Outcome Score for patellofemoral pain and osteoarthritis (KOOS-PF), Pain Catastrophizing Scale (PCS) and Tampa Scale for Kinesiophobia (TSK). RESULTS: The study was successful in recruiting and retaining participants and was delivered as intended. In addition, sufficient clinical data were generated to calculate the required sample size for a future study of efficacy CONCLUSIONS: This study which featured a 30-minute education session targeting levels of catastrophizing and kinesiophobia is feasible and identified that the TSK may be the most appropriate PROMs for a future study of efficacy of this intervention. Allowing for a drop out of 20%as identified in similar studies, 86 participants (per arm) in a two-arm study would be required for a traditional randomised controlled trial design.

scholarly journals Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lisa M. Wintner ◽  
◽  
Johannes M. Giesinger ◽  
Monika Sztankay ◽  
Andrew Bottomley ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Adverse Event ◽  
Adverse Events ◽  
Controlled Trial ◽  
Control Group ◽  
Rater Reliability ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

scholarly journals A Brief Mindfulness-Based Intervention for Primary Care Physicians: A Pilot Randomized Controlled Trial

2016 ◽  
Vol 12 (1) ◽  
pp. 83-91 ◽  
Author(s):  
David A. Schroeder ◽  
Elizabeth Stephens ◽  
Dharmakaya Colgan ◽  
Matthew Hunsinger ◽  
Dan Rubin ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Primary Care Physicians ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Primary care physicians experience high rates of burnout, which results in diminished quality of life, poorer quality of care, and workforce attrition. In this randomized controlled trial, our primary aim was to examine the impact of a brief mindfulness-based intervention (MBI) on burnout, stress, mindfulness, compassion, and resilience among physicians. A total of 33 physicians completed the baseline assessment and were randomized to the Mindful Medicine Curriculum (MMC; n = 17) or waitlist control group (n = 16). Participants completed self-report measures at baseline, post-MBI, and 3-month follow-up. We also analyzed satisfaction with doctor communication (DCC) and overall doctor rating (ODR) data from patients of the physicians in our sample. Participants in the MMC group reported significant improvements in stress (P < .001), mindfulness (P = .05), emotional exhaustion (P = .004), and depersonalization (P = .01) whereas in the control group, there were no improvements on these outcomes. Although the MMC had no impact on patient-reported DCC or ODR, among the entire sample at baseline, DCC and ODR were significantly correlated with several physician outcomes, including resilience and personal achievement. Overall, these findings suggest that a brief MBI can have a positive impact on physician well-being and potentially enhance patient care.

Phase III non-randomized controlled trial of PROMPT-Care, an eHealth intervention utilizing patient reported outcomes in routine clinical care: Impact on emergency department presentations.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6510-6510 ◽  
Author(s):  
Afaf Girgis ◽  
Ivana Durcinoska ◽  
Anthony Arnold ◽  
Nasreen Kaadan ◽  
Andrew Alexis Miller ◽  
...  
Keyword(s):  
Emergency Department ◽  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Controlled Trial ◽  
Phase Iii ◽  
Control Group ◽  
Diverse Population ◽  
Patient Reported ◽  
The Impact

6510 Background: The significant impact of routine assessment and clinical utilization of patient-reported outcomes (PRO) on patient and survival outcomes and reduced emergency department (ED) presentations has been demonstrated in specific patient populations (e.g. advanced cancer). This controlled trial evaluated the impact of an eHealth system, PROMPT-Care, on ED presentations in a diverse population of cancer patients from four oncology treatments centers. Methods: All adult patients receiving cancer care (including adjuvant therapy and follow-up) were eligible, excepting those with a diagnosis of a hematological malignancy, insufficient English literacy or no internet access outside of the clinic. Intervention (PROMPT-Care) patients completed monthly online assessments comprising 61 items of distress, common symptoms and unmet needs, with PRO results electronically transferred into the electronic medical record (EMR). In “real-time”, the care team accessed patients’ PRO summary reports to guide their care, an email alert notified nurses of ongoing unresolved issues between visits, and patients received links to support self-management. Control group patients (n = 2,288) comprised the general cancer patient population receiving usual care at the participating cancer therapy centers. Multivariable negative binomial regression was used to compare between-group differences. Results: From April 2016 to March 2018, 345 eligible patients (mean age 62, 58% female, 27% stage IV) participated and were sent at least four assessments within the first six months on trial. On average, control patients had 30 ED presentations and PROMPT-Care patients had 21 ED presentations per 10,000 patient days. After adjusting for age, sex and stage of disease, PROMPT-Care patients had 26% (95% CI 0.2%, 57%) fewer ED presentations compared to the control group (p = 0.0483). Conclusions: The PROMPT-Care intervention resulted in significantly fewer ED presentations in a broad population of cancer patients, including those currently undergoing cancer treatment or are in follow-up, and patients with a wide range of tumor types. The results support its utility as an improved model for ongoing supportive care for a diverse population, with potential healthcare cost savings. Clinical trial information: ACTRN12616000615482.

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

Impact of an Amaranth-Sorghum Grains Product on Nutrient Intake of Children Aged 6-23 Months in Kiandutu Slums, Thika, Kenya

10.37512/700 ◽  
2020 ◽  
Keyword(s):  
Nutrition Education ◽  
Nutrient Intake ◽  
Controlled Trial ◽  
Poor Quality ◽  
Control Group ◽  
Composite Flour ◽  
Monthly Basis ◽  
Sorghum Flour ◽  
Baseline Characteristics ◽  
The Impact

Poor quality complementary foods contribute to undernutrition in children aged 6-23 months. Therefore, there is need to explore foods that will provide adequate nutrients for this age group. This study aimed at determining the impact of a sorghum-amaranth composite flour porridge on nutrient intake of children aged 6-23 months. A randomized controlled trial was conducted at Kiandutu slum, Thika, Kenya. Children in the control group (CG), received a maize-sorghum flour while those in the treatment group (TG) received an amaranth-sorghum flour. The sample size per study group was 73 mother-child pairs. The children in the TG received Kcal 1000 worth of porridge/day while those in the CG received Kcal 266.8/day. Mothers of children in both groups were given nutrition education at baseline, and monthly, for six months. Food intake data was taken at baseline, then monthly for six months. Descriptive statistics were used to describe nutrient intake. Chi square and Mann Whitney U test were was used to compare the baseline characteristics of the two groups and their nutrient intake, respectively. At baseline characteristics of the two groups were similar. On a monthly basis, nutrient intake in the TG was significantly higher for a majority of the nutrients than in the CG. The product can contribute to preventing under-nutrition in children aged 6-23 months.

scholarly journals Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

2011 ◽  
Vol 29 (8) ◽  
pp. 1029-1035 ◽  
Author(s):  
Donna L. Berry ◽  
Brent A. Blumenstein ◽  
Barbara Halpenny ◽  
Seth Wolpin ◽  
Jesse R. Fann ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinic Visit ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Cancer Symptoms ◽  
Patient Reported ◽  
Life Issues ◽  
Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

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.

scholarly journals The impact of vildagliptin on the daily glucose profile and coronary plaque stability in impaired glucose tolerance patients with coronary artery disease: VOGUE—A multicenter randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroyuki Yamamoto ◽  
Akihide Konishi ◽  
Toshiro Shinke ◽  
Hiromasa Otake ◽  
Masaru Kuroda ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Fibrous Cap ◽  
Multicenter Randomized Controlled Trial ◽  
The Mean ◽  
Artery Disease ◽  
Fibrous Cap Thickness ◽  
The Impact

Abstract Background The impact of reduction in glycemic excursion on coronary plaques remains unknown. This study aimed to elucidate whether a dipeptidyl peptidase 4 inhibitor could reduce the glycemic excursion and stabilize the coronary plaques compared with conventional management in coronary artery disease (CAD) patients with impaired glucose tolerance (IGT). Methods This was a multicenter, randomized controlled trial including CAD patients with IGT under lipid-lowering therapy receiving either vildagliptin (50 mg once a day) or no medication (control group) regarding glycemic treatment. The primary endpoint was changes in the minimum fibrous cap thickness and lipid arc in non-significant native coronary plaques detected by optical coherence tomography at 6 months after intervention. Glycemic variability expressed as the mean amplitude of glycemic excursion (MAGE) measured with a continuous glucose monitoring system was evaluated before and 6 months after intervention. Results A total of 20 participants with 47 lesions were allocated to either the vildagliptin group (10 participants, 22 lesions) or the control group (10 participants, 25 lesions). The adjusted difference of mean changes between the groups was − 18.8 mg/dl (95% confidence interval, − 30.8 to − 6.8) (p = 0.0064) for the MAGE (vildagliptin, − 20.1 ± 18.0 mg/dl vs. control, 2.6 ± 12.7 mg/dl), − 22.8° (− 40.6° to − 5.1°) (p = 0.0012) for the mean lipid arc (vildagliptin, − 9.0° ± 25.5° vs. control, 15.8° ± 16.8°), and 42.7 μm (15.3 to 70.1 μm) (p = 0.0022) for the minimum fibrous cap thickness (vildagliptin, 35.7 ± 50.8 μm vs. control, − 15.1 ± 25.2 μm). Conclusions Vildagliptin could reduce the MAGE at 6 months and may be associated with the decreased lipid arc and increased minimum FCT of the coronary plaques in CAD patients with IGT as compared with the control group. These findings may represent its potential stabilization effect on coronary plaques, which are characteristic in this patient subset. Trial registration Registered in the UMIN clinical trial registry (UMIN000008620), Name of the registry: VOGUE trial, Date of registration: Aug 6, 2012, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000010058

scholarly journals Improved adherence with Medicines Use Review service in Slovenia: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Urška Nabergoj Makovec ◽  
Igor Locatelli ◽  
Mitja Kos
Keyword(s):  
Medication Adherence ◽  
Controlled Trial ◽  
Test Group ◽  
Multiple Linear Regression Model ◽  
Relative Difference ◽  
Control Group ◽  
Adherence Support ◽  
Medicines Use ◽  
The Impact ◽  
Medicines Use Review

Abstract Background Based on several existing patient-oriented activities, Medicines Use Review (MUR) service was standardized and officially adopted in Slovenia in 2015. Service aims to provide adherence support and ensure safe and effective medicines use. Therefore, the aim of the study was to evaluate the benefits of MUR in Slovenia, primarily the impact on medication adherence. Methods A randomised controlled trial was performed in community pharmacies to compare MUR with standard care. Patients were randomised into either the test (patients received MUR by a certified MUR provider at visit 1), or control group. The study primary outcome was self-reported adherence to multiple medications, assessed by electronic ©Morisky Widget MMAS-8 Software at the first visit (V1) and after 12 weeks (V2). A sub-analysis of intentional and unintentional non-adherence was performed. MUR impact was defined as the relative difference in ©MMAS-8 score after 12 weeks between the test and control group. A multiple linear regression model was used to predict MUR impact based on baseline adherence (low versus medium and high). Several secondary outcomes (e.g. evaluation of drug-related problems (DRPs)) were also assessed. Results Data from 153 (V1) and 140 (V2) patients were analysed. Baseline adherence was low, moderate and high in 17.6, 48.4 and 34.0% patients, respectively. In the low adherence subpopulation, test group patients showed a 1.20 point (95% CI = 0.16–2.25) increase in total ©MMAS-8 score (p = 0.025) compared to control group patients. A 0.84 point (95% CI = 0.05–1.63) increase was due to intentional non-adherence (p = 0.038), and a 0.36 point (95% CI = − 0.23-0.95) was due to unintentional non-adherence (p = 0.226). Additionally, statistically significant decrease in the proportion of patients with manifested DRPs (p < 0.001) and concerns regarding chronic medicines use (p = 0.029) were revealed. Conclusion MUR service in Slovenia improves low medication adherence and is effective in addressing DRPs and concerns regarding chronic medicines use. Trial registration ClinicalTrials.gov - NCT04417400; 4th June 2020; retrospectively registered.

Sign in / Sign up

Export Citation Format

Share Document