scholarly journals Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Vincent CM Cox ◽  
Vera PM Schepers ◽  
Marjolijn Ketelaar ◽  
Caroline M van Heugten ◽  
Johanna MA Visser-Meily
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Secondary Outcome ◽  
Face To Face ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Blended Care

BACKGROUND Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. OBJECTIVE This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. METHODS A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. RESULTS The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. CONCLUSIONS The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. CLINICALTRIAL Dutch Trial Register NTR6197; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6197 (Archived by WebCite at http://www.webcitation.org/6xHBAxx0y)

scholarly journals Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial

2018 ◽  
Vol 7 (2) ◽  
pp. e60 ◽  
Author(s):  
Vincent CM Cox ◽  
Vera PM Schepers ◽  
Marjolijn Ketelaar ◽  
Caroline M van Heugten ◽  
Johanna MA Visser-Meily
Keyword(s):  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Blended Care

Telemedicine for New Neurological Outpatients: Putting a Randomized Controlled Trial in the Context of Everyday Practice

2002 ◽  
Vol 8 (5) ◽  
pp. 270-273 ◽  
Author(s):  
Richard Chua ◽  
John Craig ◽  
Thomas Esmonde ◽  
Richard Wootton ◽  
Victor Patterson
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Retrospective Review ◽  
Controlled Trial ◽  
The Other ◽  
Everyday Practice ◽  
General Hospitals ◽  
Face To Face ◽  
Randomized Controlled ◽  
General Physicians

In a retrospective review, the telemedical management of 65 outpatients from a randomized controlled trial (RCT) of telemedicine for non-urgent referrals to a consultant neurologist was compared with the management of 76 patients seen face to face in the same trial, with that of 150 outpatients seen in the neurology clinics of district general hospitals and with that of 102 neurological outpatients seen by general physicians. Outcome measures were the numbers of investigations and of patient reviews. The telemedicine group did not differ significantly from the 150 patients seen face to face by neurologists in hospital clinics in terms of either the number of investigations or the number of reviews they received. Patients from the RCT seen face to face had significantly fewer investigations but a similar number of reviews to the other 150 patients seen face to face by neurologists (the disparity in the number of investigations may explain the negative result for telemedicine in that RCT). Patients with neurological symptoms assessed by general physicians had significantly more investigations and were reviewed significantly more often than all the other groups. Patients from the RCT seen by telemedicine were not managed significantly differently from those seen face to face by neurologists in hospital clinics but had significantly fewer investigations and follow-ups than those patients managed by general physicians. The results suggest that management of new neurological outpatients by neurologists using telemedicine is similar to that by neurologists using a face-to-face consultation, and is more efficient than management by general physicians.

scholarly journals PREWARMING FOR PREVENTION OF PERIOPERATIVE HYPOTHERMIA IN PATIENTS WITH COMBINED EPIDURAL AND GENERAL ANESTHESIA: A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
General Anesthesia ◽  
Outcome Measures ◽  
Medical Center ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Perioperative Hypothermia ◽  
Randomized Controlled ◽  
Physical Status Classification ◽  
American Society

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.

scholarly journals Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Ira Kantrowitz-Gordon ◽  
Susan M. McCurry ◽  
Carol A. Landis ◽  
Rachel Lee ◽  
Dahee Wi
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Pregnant Women ◽  
Outcome Measures ◽  
Mindfulness Meditation ◽  
Controlled Trial ◽  
Self Management ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Randomized Controlled

Abstract Background Sleep deficiency affects a majority of pregnant women with significant impact on daily function, mood, and pregnancy and birth outcomes. This ongoing study combines two evidence-based strategies for improving sleep and mood, mindfulness meditation and cognitive-behavioral therapy for insomnia (CBT-I), in a unique online format to address the particular needs of pregnant women. The purpose of this study is to test the feasibility and estimate the efficacy of this novel 6-week online mindfulness meditation intervention to help pregnant women in remission from depression self-manage insomnia. Methods This is a two-arm, parallel group randomized controlled trial. A total of 50 pregnant women between 12 and 28 weeks gestation will be recruited from the community and randomly assigned to a mindfulness or education-only control group in a 1:1 ratio. During the study, all participants will complete six weekly online modules, daily sleep diaries, and optional participation in a treatment-specific online discussion forum. Feasibility outcome measures will include study recruitment, retention, intervention adherence (number of online modules completed, number of meditation days per week), and intervention acceptability (8-item questionnaire). The primary clinical outcome measure will be sleep quality measured with the Pittsburgh Sleep Quality Index. Secondary outcome measures will include sleep measured with actigraphy and diaries (sleep efficiency, total sleep time, total wake time), Patient-Reported Outcomes Measurement Information System (PROMIS) measures (fatigue, sleep-related impairment, sleep disturbance); mood (depression, anxiety, positive affect, quality of life); and self-management and behavior change (potential self-efficacy, self-regulation, sleep problem acceptance, and trait mindfulness). Assessments will occur at baseline and post-intervention; an additional acceptability survey will be completed 4 weeks postpartum. Analyses will examine within-group differences in outcome change scores from baseline to post-intervention. Open-ended feedback will be analyzed using qualitative content analysis. Discussion This research is innovative in addressing sleep in pregnancy using a self-management research design and methods that can be accessible and cost-effective for large numbers of pregnant women. The results from this study will inform intervention refinement and efficacy testing of the intervention in a larger randomized controlled trial. Trial registration ClinicalTrials.gov, NCT04016428. Registered on 11 July 2019. Updated version registered on 26 July 2019.

The effects of vestibular rehabilitation on dizziness and balance problems in patients after traumatic brain injury: a randomized controlled trial

2018 ◽  
Vol 33 (1) ◽  
pp. 74-84 ◽  
Author(s):  
Ingerid Kleffelgaard ◽  
Helene Lundgaard Soberg ◽  
Anne-Lise Tamber ◽  
Kari Anette Bruusgaard ◽  
Are Hugo Pripp ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Vestibular Rehabilitation ◽  
Secondary Outcome ◽  
Group Differences ◽  
Randomized Controlled ◽  
Balance Problems

Objective: To investigate the effects of group-based vestibular rehabilitation in patients with traumatic brain injury. Design: A single-blind randomized controlled trial. Setting: University Hospital (recruitment and baseline assessments) and Metropolitan University (experimental intervention). Subjects: A total of 65 patients (45 women) with mild-to-moderate traumatic brain injury (mean age 39.4 ± 13.0 years) were randomly assigned to intervention ( n = 33) or control group ( n = 32). Intervention: Group-based vestibular rehabilitation for eight weeks. Participants were tested at baseline (3.5 ± 2.1 months after injury) and at two post-intervention follow-ups (2.7 ± 0.8 and 4.4 ± 1.0 months after baseline testing). Main measures: Primary outcome: Dizziness Handicap Inventory. Secondary outcome: High-Level Mobility Assessment Tool. Other outcomes: Vertigo Symptom Scale; Rivermead Post-concussion Symptoms Questionnaire; Hospital Anxiety and Depression Scale; and Balance Error Scoring System. Between-group differences were analyzed with a linear mixed-model analysis for repeated measurements. Results: At baseline, no group differences were revealed (personal factors, clinical characteristics and outcome measures). At the first follow-up, statistically significant mean differences in favor of the intervention were found in the primary (−8.7, 95% confidence interval (CI): −16.6 to −0.9) and secondary outcomes (3.7 points, 95% CI: 1.4–6.0). At the second follow-up, no significant between-group differences were found. No significant between-group differences in the other outcomes were found at the two follow-ups. Conclusion: The intervention appeared to speed up recovery for patients with dizziness and balance problems after traumatic brain injury. However, the benefits had dissipated two months after the end of the intervention.

Tinnitus Management: Randomized Controlled Trial Comparing Extended-Wear Hearing Aids, Conventional Hearing Aids, and Combination Instruments

2017 ◽  
Vol 28 (06) ◽  
pp. 546-561 ◽  
Author(s):  
James A. Henry ◽  
Garnett McMillan ◽  
Serena Dann ◽  
Keri Bennett ◽  
Susan Griest ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Hearing Aids ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Treatment Groups ◽  
Randomized Controlled ◽  
Point Reduction ◽  
Clinically Significant

Background: Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. Purpose: The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4–5 months, participants returned to complete final outcome measures, which concluded their study participation. Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A “clinically significant” improvement in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67% of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific questionnaires and QuickSIN showed improvements following use of the hearing aids but these improvements did not differ across device groups. Conclusions: There is insufficient evidence to conclude that any of these devices offers greater relief from tinnitus than any other one tested. However, all devices appear to offer some improvement in the functional effects of tinnitus.

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