Abstract WP221: Very Brief Intervention Improves Stroke Response in a Randomized Trial: Stroke Ready Very Brief Intervention

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Lesli E Skolarus ◽  
Maria Cielito Robles ◽  
Springer Mellanie ◽  
Chun Chieh Lin ◽  
Casey Corches ◽  
...  
Keyword(s):  
Brief Intervention ◽  
Action Plan ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Average Score ◽  
Control Group ◽  
Symptom Recognition ◽  
Stroke Symptom ◽  
One To One

Introduction: Stroke pre-hospital delay has not improved over time. Hypothesis: Stroke Ready, a very brief (5 minute), theory based, peer-led, stroke preparedness intervention, will increase stroke response compared with a control intervention. Methods: We performed a randomized, single-blind controlled trial among adults in Flint, MI. The stroke preparedness intervention group received a Stroke Ready pamphlet and action plan, while the control group received stroke prevention materials - both delivered during a one-to-one interaction with a trained peer educator. Research staff, blinded to group intervention assignment, assessed baseline and immediate post-intervention outcomes. Primary outcome was change in stroke response (behavioral intent to call 911) using a community-modified stroke action test (range 0-12). Secondary outcome was change in stroke symptom recognition (range 0-8). We conducted descriptive analyses and used a linear regression model to evaluate the effect of the intervention on stroke response after adjustment for pre-intervention intent, age, education, race, marital status, history of stroke, stroke in someone they know and psychological constructs. Results: We enrolled 129 participants (74 intervention; 55 control). Mean age was 60 years (SD 14); 61% were women, 89% were African American and 19% were not high school graduates. Intervention participants had greater improvement in stroke response than control participants (figure 1), which remained after full adjustment (improvement in average score for stroke response was 1.7 higher in intervention participants than control participants, 95% CI 0.9-2.5, p<0.0001). There was no difference in stroke symptom recognition (figure 1). Conclusion: The Stroke Ready very brief intervention increased stroke response. This new approach using a very brief, one-to-one interaction with trained peer educators is a promising, scalable, intervention to increase stroke response.

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

scholarly journals Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

2019 ◽  
Vol 20 ◽  
Author(s):  
Iñaki Aguirrezabal ◽  
Maria Soledad Pérez de San Román ◽  
Raquel Cobos-Campos ◽  
Estibalitz Orruño ◽  
Arturo Goicoechea ◽  
...  
Keyword(s):  
Primary Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Basque Country ◽  
Intervention Group ◽  
Cost Effective ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

An Interactive Web-Based Intervention to Achieve Healthy Weight in Young Children

2017 ◽  
Vol 57 (5) ◽  
pp. 547-557 ◽  
Author(s):  
Ellen R. Wald ◽  
Linda J. Ewing ◽  
Stacey C. L. Moyer ◽  
Jens C. Eickhoff
Keyword(s):  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Intervention Group ◽  
Lifestyle Changes ◽  
Secondary Outcome ◽  
Control Group ◽  
Healthy Weight ◽  
Healthy Behavior ◽  
Reduced Body ◽  
Z Scores

This prospective, randomized, controlled trial for parents of overweight and obese 3- to 7-year-olds was performed to assess the feasibility of a program promoting healthy eating and lifestyle by targeting parents as agents of change. The intervention was composed of 6-in-person group sessions and a customized website over 12 months. The control group received customary care. The primary outcome was feasibility of the intervention to promote healthy behavior change measured by attendance. The secondary outcome was effectiveness assessed by attaining reduced body mass index (BMI) z scores, healthy behavior changes and increased parent self-efficacy. Seventy-three child-parent dyads were enrolled; 14 parents never attended any sessions. Participation in follow-up assessments did not meet the hypothesized level. Ultimate BMI z scores did not differ between control and intervention groups. Parenting skills did not improve in the intervention group. This intervention to achieve healthy lifestyle changes in children via their parents as “change agents” was unsuccessful.

Better balance: a randomised controlled trial of oculomotor and gaze stability exercises to reduce risk of falling after stroke

2020 ◽  
pp. 026921552095633
Author(s):  
Anabela Correia ◽  
Carla Pimenta ◽  
Marta Alves ◽  
Daniel Virella
Keyword(s):  
Controlled Trial ◽  
Tertiary Care ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Stroke Survivors ◽  
Care Hospital ◽  
Risk Of Falling ◽  
Gaze Stability ◽  
Estimated Risk

Objective: To assess the effect of a domiciliary program of oculomotor and gaze stability exercises on the incidence of falls and risk of fall in stroke survivors. Design: Two-arm, non-blinded parallel randomized controlled trial. Subjects: Stroke survivors older than 60 years, with positive Romberg test and autonomous gait after the stroke. Setting: Physiotherapy outpatient clinic of a tertiary care hospital. Interventions: Every participant accomplished the current rehabilitation program; the intervention group was randomly allocated into an additional three weeks intervention with a domiciliary program of oculomotor and gaze stability exercises. Main measures: Primary outcome was the incidence of falls through the three weeks after the intervention started; in addition, the variation of the estimated risk for falling assessed by both Berg Balance Scale (four points) and Timed Up and Go Test (four seconds) was the secondary outcome. Results: 79 patients were recruited and 68 completed the protocol (control group 35; intervention group 33). During the follow up, falls were registered in 4/35 participants in the control group and no event occurred in the intervention group ( P = 0.064). The estimated risk for falling decreased in 11/35 control group participants and in 28/33 intervention group participants (RR 0.37; 95%CI 0.22–0.62; P < 0.001). Conclusion: After three weeks of a domiciliary program of oculomotor and gaze stability exercises, the estimated risk of falling significantly diminished and no falls occurred among the intervention group. These findings encourage further exploration of this promising intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT02280980.

Efficacy of an online intervention for treatment of depressive disorders: a three-arm randomized controlled trial comparing guided and unguided self-help with waitlist control (Preprint)

2021 ◽  
Author(s):  
Krämer Rico
Keyword(s):  
Depressive Symptoms ◽  
Depressive Disorders ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Intervention Group ◽  
Online Intervention ◽  
Self Report ◽  
Secondary Outcome ◽  
Control Group

BACKGROUND Digital health applications are efficacious treatment options for mild-to-moderate depressive disorders. However, the extent to which psychological guidance increases the efficacy of these applications is controversial. OBJECTIVE We evaluated the efficacy of the online intervention “Selfapy” for unipolar depression. We also investigated differences between a psychotherapist-guided vs. unguided version compared with those from a control group. METHODS A cohort of 401 participants with mild-to-severe depressive disorders were assigned randomly to either participate in a guided version of Selfapy (involving weekly telephone calls of 25-min duration), an unguided version of Selfapy, or to the waiting list (control group). Selfapy is a cognitive behavioral therapy-based intervention for depressive disorders of duration 12 weeks. Symptom assessment was undertaken at T1 (before study entrance), T2 (after 6 weeks), T3 (post-treatment, after 12 weeks), and T4 (follow-up, after 6 months). The main outcome was reduction in depressive symptoms in the Beck Depression Inventory (BDI-II) from T1 to T3. Secondary-outcome parameters were the Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR 16) and Beck Anxiety Inventory (BAI). RESULTS A total of 297 out of 401 participants (74.06%) completed the post-measurement at T3. In the primary analysis, both intervention groups showed a significantly higher reduction in depressive symptoms (BDI-II) from T1 to T3 compared with that in the control group, with high within-effect sizes (guided: d = 1.46; unguided d = 1.36). No significant differences were found for guided vs. unguided treatment groups. The response rate (BDI-II) for intention-to-treat data in the guided version was 46.4%, 40.0% for the unguided version, and 2.0% in the control group. After 6 months (T4), treatment effects could been maintained for both intervention groups (BDI-II) without differences between either intervention group. CONCLUSIONS Conclusions: Selfapy can help to reduce depressive symptoms in guided or unguided version. Follow-up data suggest that these effects could be maintained. The guided version was not superior to the unguided version. CLINICALTRIAL Trial Registration: Current Controlled Trial DRKS00017191 Date of registration: 14 May 2019 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-021-05218-4

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 Does Nursery-Based Intensified Anticipatory Guidance Reduce Emergency Department Use for Nonurgent Conditions in the First Month of Life? A Randomized Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6
Author(s):  
Kelly Kamimura-Nishimura ◽  
Vikram Chaudhary ◽  
Folake Olaosebikan ◽  
Maryam Azizi ◽  
Sneha Galiveeti ◽  
...  
Keyword(s):  
Emergency Department ◽  
Controlled Trial ◽  
Intervention Group ◽  
Newborn Care ◽  
Secondary Outcome ◽  
Control Group ◽  
Anticipatory Guidance ◽  
Guidance Program ◽  
Significant Difference ◽  
The Impact

Objective.We aimed to evaluate the impact of an intensified anticipatory guidance program in the nursery on Emergency Department (ED) use for nonurgent conditions (NUCs) in the neonatal period.Methods. Parturient mothers of healthy newborns were randomized to an intervention group or control group. Baseline and 1-month follow-up knowledge surveys regarding newborn care were conducted. The primary outcome was the proportion of neonates who used the ED for a NUC. Secondary outcome was change in caregivers’ knowledge on NUC.Results. Of a total of 594 mothers, 323 (54%) agreed to participate and were randomized to intervention (n=170) or control (n=153) group. Most were Hispanic (68%), single (61%), primiparous (39%), and without high school diploma (44%). 35 (21%) neonates in the intervention group and 41 (27%) in the control group were brought at least once for a NUC to the ED (p=0.12). There was no statistically significant difference in within subject change on knowledge scores between the two study arms.Conclusions. Neonatal ED visits for NUCs occur frequently. This nursery-based intensified anticipatory guidance program had no statistically significant impact on neonatal ED use for NUC, nor on neonatal care-relevant knowledge among parturient mothers. Alternative modalities and timing of parental educational intervention may need to be considered. This trial is registered with Clinical Trials NumberNCT01859065(Clinicaltrials.gov).

scholarly journals Triaging and Referring In Adjacent General and Emergency Departments (the TRIAGE trial): a cluster randomised controlled trial

2021 ◽  
Author(s):  
Stefan Morreel ◽  
Hilde Philips ◽  
Diana De Graeve ◽  
Koenraad G Monsieurs ◽  
Jarl Kampen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Predictive Values ◽  
Randomised Controlled

Objectives: To determine the effectiveness and safety of a tool diverting low urgency patients eligible for primary care from an emergency department (ED) to the adjacent general practitioner cooperative (GPC). Methods: Unblinded, randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was nurse-led triage using a new tool assigning patients to either ED or GPC. During intervention weekends, patients were encouraged to follow this assignment while it was not communicated to the patients during control weekends (they remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC during intervention and control weekends. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care eligible patients (with the opinion of the treating physician as the gold standard). Results: In the intervention group, 838/6374 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC (secondary outcome), in the control group 431/1744 (24.7%, 95% CI 22.7 to 26.8). In the intervention group, 599/6374 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the chosen MTS presentational flowchart, patient's age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) patients were referred back to the ED of which three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions: ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. ClinicalTrials.gov Identifier: NCT03793972 Funding: Research Foundation, Flanders (FWO)

Does Additional Extracorporeal Shock Wave Therapy Improve the Effect of Isolated Percutaneous Radiofreqency Coblation in Patients with Insertional Achilles Tendinopathy? Study Protocol for A Randomized Controlled Clinical Trial

2020 ◽  
Author(s):  
Yu-Jie Song ◽  
Wen-Kai Xuan ◽  
Ying-Hui Hua
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Achilles Tendinopathy ◽  
Conclusive Evidence ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Extracorporeal Shock Wave ◽  
Insertional Achilles Tendinopathy

Abstract Background: No conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous radiofreqency coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence shows that either treatment promote the regeneration of the tendon or if the combination of these 2 interventions offer better function and less pain than one therapy. Methods: The study is a randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients with insertional Achilles tendinopathy who are not satisfied with the effect of conservative treatment will be screened. A minimum of 38 patients will be enrolled after deciding to participate in the trial on an informed basis. Then the intervention group and the control group perform radial ESWT and sham-ESWT respectively at 6 months after percutaneous radiofreqency coblation. The primary outcome will be the Victorian Institute of Sports Assessment Achilles (VISA-A) Score. Secondary outcome measures will be Foot and Ankle Outcome Score (FAOS) scale, Visual Analogue Scale (VAS), Tegner Score, and MRI ultra-short echo time (UTE) T2* value. The assessments will occur in 6 months, 1 year, and 2 years post-operatively. The differences between 2 groups will be conducted as intention-to-treat basis. Discussion: We aim to investigate if radiofreqency coblation associated with ESWT can provide more encouraging imaging findings as well as functional and clinical outcomes regarding the treatment of the IAT comparing to the single radiofreqency coblation treatment.Trial registration: ChiCTR1800017898; Pre-results. Registered on 20 August 2018.

scholarly journals Effects of a person-centred telephone support on fatigue in people with chronic heart failure: Subgroup analysis of a randomised controlled trial

2019 ◽  
Vol 19 (5) ◽  
pp. 393-400 ◽  
Author(s):  
Sara Wallström ◽  
Lilas Ali ◽  
Inger Ekman ◽  
Karl Swedberg ◽  
Andreas Fors
Keyword(s):  
Heart Failure ◽  
Chronic Heart Failure ◽  
Usual Care ◽  
Subgroup Analysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Secondary Outcome Measure ◽  
Telephone Support

Introduction: Fatigue is a prevalent symptom that is associated with various conditions. In patients with chronic heart failure (CHF), fatigue is one of the most commonly reported and distressing symptoms and it is associated with disease progression. Person-centred care (PCC) is a fruitful approach to increase the patient’s ability to handle their illness. Aim: The aim of this study was to evaluate the effects of PCC in the form of structured telephone support on self-reported fatigue in patients with CHF. Method: This study reports a subgroup analysis of a secondary outcome measure from the Care4Ourselves randomised intervention. Patients ( n=77) that were at least 50 years old who had been hospitalized due to worsening CHF received either usual care ( n=38) or usual care and PCC in the form of structured telephone support ( n=39). Participants in the intervention group created a health plan in partnership with a registered nurse. The plan was followed up and evaluated by telephone. Self-reported fatigue was assessed using the Multidimensional Fatigue Inventory 20 (MFI-20) at baseline and at 6 months. Linear regression was used to analyse the change in MFI-20 score between the groups. Results: The intervention group improved significantly from baseline to the 6-month follow-up compared with the control group regarding the ‘reduced motivation’ dimension of the MFI-20 (Δ -1.41 versus 0.38, p=0.046). Conclusion: PCC in the form of structured telephone support shows promise in supporting patients with CHF in their rehabilitation, improve health-related quality of life and reduce adverse events. Trial registration ISRCTN.com ISRCTN55562827

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