The use of digitally collected patient-reported outcome measures for newly operated patients with total knee and hip replacements to improve post-treatment recovery: study protocol for a randomized controlled trial
DiscussionThe study is expected to deliver an important contribution to test PROMs as an intervention tool and examine the determinants of high-quality endoprosthetic care. Depending on a positive and cost-effective impact, the goal is to transfer the study design into standard care. During the trial design phase, several insights have been discovered, and there were opportunities for efficient digital monitoring limited by existing legacy care models. Digitalization in hospital processes and the implementation of digital tools still represent challenges for hospital personnel and patients. Furthermore, data privacy regula...
Source: Trials - April 8, 2020 Category: Research Source Type: clinical trials
Cost-utility analysis of curative and maintenance repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant unipolar depression: a randomized controlled trial protocol
This study assesses the cost-effectiveness of the adjunctive and maintenance low frequency rTMS on the right dorsolateral prefrontal cortex versus TAU alone. A total of 318 patients suffering from a current TRD will be enrolled. The primary endpoint is to investigate the incremental cost-effectiveness ratio (ICER) (ratio costs / quality-adjusted life-years [QALY] measured by the Euroqol Five Dimension Questionnaire) over 12 months in a population of patients assigned to one of three arms: systematic M-rTMS for responders (arm A); additional new rTMS cure in case of mood deterioration among responders (arm B); and a plac...
Source: Trials - April 4, 2020 Category: Research Source Type: clinical trials
Cost-utility Analysis, Cost-effectiveness Analysis, Budget Impact Analysis
Condition: Peripheral Arterial Disease Interventions: Other: Systematic screening of AOMI by BPI measurement.; Other: Management of CVRF by a motivationnal interviewing. Sponsors: University Hospital, Tours; Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ; Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure; Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST; Collèges Régionaux de M édecine Générale- CRMG - 37400 Amboise; Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE; Collèges Région...
Source: ClinicalTrials.gov - February 25, 2020 Category: Research Source Type: clinical trials
Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)
This study aims to prove a beneficial effect of PFR on fecal incontinence, quality of life, and costs in rectal cancer patients after sphincter-saving surgery compared to standard treatment.MethodsThe FORCE trial is a multicenter, two-armed, randomized clinical trial. All patients that underwent LAR are recruited from the participating hospitals and randomized for either standard treatment or a standardized PFR program. A total of 128 patients should be randomized. Optimal blinding is not possible. Stratification will be done in variable blocks (gender and additional radiotherapy). The primary endpoint is the Wexner incont...
Source: Trials - January 27, 2020 Category: Research Source Type: clinical trials
Budget Impact Analysis of Discontinuing Tyrosin Kinase Inhibitors in Patients With Chronic Myeloid Leukemia Achieving a Complete Molecular Response by Using Probabilistic Markov Approach
Conditions: Hematologic Diseases; Chronic Myeloid Leukemia Intervention: Other: Budget impact Sponsors: University Hospital, Bordeaux; Bordeaux PharmacoEpi Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - May 30, 2018 Category: Research Source Type: clinical trials
