| 1. |
- Bergling, Karin, et al.
(författare)
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Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR) : Study protocol for a randomized controlled crossover trial
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 6:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: It has been estimated that automated peritoneal dialysis (APD) is currently the fastest growing renal replacement therapy in the world. However, in light of the growing number of diabetic patients on peritoneal dialysis (PD), the unwanted glucose absorption during APD remains problematic. Recent results, using an extended 3-pore model of APD, indicated that large reductions in glucose absorption are possible by using optimized bi-modal treatment regimens, having "UF cycles"using a higher glucose concentration, and "Clearance cycles"using a low concentration or, preferentially, no glucose. The present study is designed to test the theoretical prediction of a lower glucose absorption using these novel regimes. Methods: This study is a randomized single-center, open-label, prospective study. Prevalent PD patients between 18 and 75 years old without known catheter problems or recent peritonitis are eligible for inclusion. Patients are allocated to a first treatment session of either standard APD (6 × 2 L 1.36% over 9 h) or optimized APD (7 × 2 L 2.27% + 5 × 2 L 0.1% over 8 h). A second treatment session using the other treatment will be performed in a crossover fashion. Samples of the dialysis fluid will be taken before and after the treatment, and the volume of the dialysate before and after the treatment will be carefully assessed. The primary endpoint is difference in glucose absorption between the optimized and standard treatment. Secondary endpoints are ultrafiltration, sodium removal, Kt/V urea, and Kt/V Creatinine. The study will be closed when a total of 20 patients have successfully completed the interventions or terminated according to interim analysis. A Monte Carlo power analysis shows that the study has 80% power to detect a difference of 10 g (in line with that of theoretical results) in glucose absorption between the two treatments in 10 patients. Discussion: The present study is the first clinical investigation of optimized bi-modal treatments proposed by recent theoretical studies. Trial registration: ClinicalTrials.gov identifier: NCT04017572. Registration date: July 12, 2019, retrospectively registered.
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| 2. |
- Ekvall Hansson, Eva, et al.
(författare)
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Vestibular rehabilitation for persons with stroke and concomitant dizziness : a pilot study
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Nature. - 2055-5784. ; 6:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Dizziness is common among patients with first time stroke. It affects self-perceived health and is a risk factor for falls. Vestibular rehabilitation (VR) is effective for treating dizziness among various conditions, but the effect of dizziness with origin in the central nervous system is poorly studied.This pilot study of a randomized controlled trial aimed at investigating a vestibular rehabilitation programme among patients with first time stroke and concomitant dizziness. A second aim was to study the feasibility of performing the randomized controlled trial.Methods: The participants were computer generated randomized to either an intervention or a control group. The intervention comprised of four different vestibular rehabilitation exercises, adapted for each patient and usual rehabilitation. The control group received usual rehabilitation without the vestibular rehabilitation exercises. Outcome measures used were The Activities-specific Balance Confidence Scale, the Berg Balance Scale, the Functional Gait Assessment Scale and the EuroQol-5D. Feasibility was studied in terms of recruitment, adherence and retention rates, also as the ability to collect primary and secondary outcomes as well as to find indications of treatment differences.Results: Self-rated health improved for all participants. No other differences between baseline and follow-up were detected neither within nor between groups. Recruitment rate was 23%, adherence to the intervention 90%, retention rate 69% and ability to collect outcome measures 90%. No adverse events occurred.Conclusion: Both the intervention and the control groups improved in self-perceived health. The measures of feasibility were satisfactory in this study, apart from a low recruitment rate.
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| 3. |
- Molander, Olof, et al.
(författare)
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Internet-based cognitive behavior therapy for problem gambling in routine care : protocol for a non-randomized pilot and feasibility trial
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Background: Problem gambling and gambling disorder are major public health concerns worldwide, and awareness of associated negative consequences is rising. In parallel, treatment demand has increased, and Internet interventions offer a promising alternative for providing evidence-based treatment at scale to a low cost.Method: We developed a novel Internet-delivered cognitive behavioral treatment for gambling, based on qualitative interviews with treatment-seeking gamblers, behavioral research on gambling behavior, and the pathway model for problem gambling. This research protocol describes a non-randomized pilot and feasibility trial conducted in routine addiction care with adult treatment-seeking patients (max N = 25) with problem gambling. The primary aim is to ensure acceptability and safety, measured by satisfaction, credibility, working alliance, and possible negative effects. Secondary aims are feasibility of study procedures in terms of recruitment and measurement procedures as well as potential effectiveness measured weekly by gambling symptoms as primary outcome and gambling behavior, quality of life, symptoms of depression and anxiety, alcohol, and drug use as secondary outcomes. Potential mediators measured weekly are loss of control, verbal rules, and well-being.Discussion: This study is innovative in several respects, regarding both treatment development and implementation. The results of the study will guide a future randomized controlled trial, as well as the development of the intervention and intervention implementation within ordinary addiction care.Trial registration: Clinical trials.gov, NCT ID: NCT03946098. Registered 10 May 2019
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| 4. |
- Mukka, Sebastian, et al.
(författare)
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A cohort study comparing internal fixation for undisplaced versus hip arthroplasty for displaced femoral neck fracture in the elderly : a pilot study for a clinical trial
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Nature. - 2055-5784. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The literature regarding undisplaced femoral neck fractures (FNF) is sparse. The aim of this prospective feasibility study is to compare the clinical outcome after undisplaced FNF treated with internal fixation (IF) and displaced FNF treated with hip arthroplasty. We hypothesized that hip arthroplasty would give a lower incidence of reoperations.Methods: A total of 235 patients were included with a median age of 84 years (range 65-99). A consecutive series of 65 patients with undisplaced FNF were treated with IF, and 170 patients with displaced FNF were treated with either a total hip arthroplasty or a hemiarthroplasty. Follow-up interviews were conducted at 1 year using the Harris Hip Score (HHS), WOMAC, and pain numeric rating scale (PNRS). The minimum follow-up time was 22 months. There was no difference in baseline data between the groups.Results: Nineteen (8%) hips required reoperation at least once at a mean of 6 months (range 0-35). The rate of reoperation was higher in the IF group compared to the hip arthroplasty group (13.8% vs. 5.9%, 95% CI 0.9-6.4). The overall 1-year and 2-year mortality was 28% and 40%, respectively, with no difference between the groups. The most common reasons for reoperations in the IF group were non-union and avascular necrosis, and 6 patients were treated with hip or excision arthroplasty. In the arthroplasty group, the most common indications were deep infection and dislocation. We did not find any differences between the groups in terms of HHS, WOMAC, and PNRS.Conclusions: In this feasibility study, we found no differences in patient-reported outcomes between the groups although IF required a higher rate of reoperations. Further randomized trials are needed to establish the optimal treatment of undisplaced FNF in the elderly.Trial registration: ClinicalTrial.org, NCT03392285. Retrospectively registered on 5 February 2018.
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| 5. |
- Steel, Craig, et al.
(författare)
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The IBER study : study protocol for a feasibility randomised controlled trial of Imagery Based Emotion Regulation for the treatment of anxiety in bipolar disorder.
- 2020
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Ingår i: Pilot and Feasibility Studies. - : Springer Science and Business Media LLC. - 2055-5784. ; 6
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Tidskriftsartikel (refereegranskat)abstract
- Background: Anxiety is highly prevalent in people diagnosed with bipolar disorder (BD), and can persist between acute episodes of mania and depression. Recent studies indicate that people with BD are prone to experiencing frequent, intrusive and emotional mental images which further fuel their levels of anxiety and mood instability. These intrusive emotional mental images represent a specific target for treatment for this disorder with the potential to reduce anxiety and improve mood stability. A new brief structured psychological intervention for BD called Imagery Based Emotion Regulation (IBER) has been developed, which translates experimental work in the area of imagery and emotion into a skills training programme to improve the regulation of intrusive and distressing emotional mental images in BD. A feasibility trial is required in order to assess whether a full randomised controlled trial is indicated in order to evaluate this approach.Methods: The design is a two-arm feasibility randomised controlled trial (RCT), with 1:1 randomisation stratified by trial site and minimised on medication status and anxiety severity. Participants are 60 individuals diagnosed with bipolar disorder and experiencing at least a mild level of anxiety. Sites are defined by the geographical boundaries of two National Health Service (NHS) Trusts, with recruitment from NHS teams, GP surgeries and self-referral. The intervention is up to 12 sessions of Imagery Based Emotion Regulation within 16 weeks. The comparator is NHS standard care. The primary aim is to assess the feasibility of conducting a powered multi-site RCT to evaluate effectiveness. Measures of anxiety, depression, mania, mood stability and health care use will be conducted at baseline, end of treatment and at 16-week follow-up.Discussion: This is the first feasibility trial of an imagery-based intervention for the treatment of anxiety in bipolar disorder. If the trial proves feasible, a large multi-site trial will be required.Trial registration: ISRCTN16321795. Registered on October 16, 2018. 10.1186/ISRCTN16321795.
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