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Found 4 Actively Recruiting clinical trials

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Research on personality disorders (PDs) in older adults is limited despite their common occurrence and significant impact on treatment due to coexisting mental and physical disorders. This study focuses on examining a new dimensional approach to diagnosing PDs, combining the Alternative Model for Personality Disorders (AMPD) and the ICD-11 criteria, which consider overall personality functioning and pathological personality traits. The aim is to evaluate whether this approach is suitable and clinically relevant for older adults compared to younger adults. Participants will complete two main self-report questionnaires, the PID-5-BF+M and the LPFS-BF 2.0, which assess maladaptive personality traits and personality functioning, respectively. The study will assess these questionnaires in both general and clinical populations, looking at validity, age-neutrality, and clinical utility. Additional clinical ratings and informant questionnaires will be collected for some patients using structured interviews. Several secondary questionnaires covering various psychological symptoms will also be analyzed retrospectively. During the study, participants will fill out the questionnaires and may be asked to have an informant complete an informant version. Researchers will evaluate personality disorder measures, their ability to differentiate PDs, and their relationship with other psychopathology symptoms. The study includes clinical ratings by trained students and retrospective analysis of test batteries. The primary outcomes include responses to the PID-5-BF+M and LPFS-BF 2.0 questionnaires within about one month of admission, with ongoing assessments to understand PD characteristics in older adults.

Age: 18Years +All GendersPhase Not Applicable
2 locations
C

Actively Recruiting

Researchers are evaluating the Cognitive Model for Behavioral Interventions (CoMBI), a person-centered, non-drug approach to reduce behavioral and psychological symptoms of dementia (BPSD) in people living in nursing homes. This study also looks at whether CoMBI can lessen caregiver burden and improve quality of life for people with dementia. The trial explores if personal factors like personality, gender, cognitive impairment level, and dementia stage affect CoMBI's effectiveness. CoMBI involves a four-step approach where caregivers observe and assess BPSD, identify core needs based on personality assessments, select targeted interventions focusing on contact, attitude, and environment, and personalize these interventions for each resident. Care plans documenting these steps are regularly updated. The study uses a stepped-wedge cluster randomized design where nursing home units start with usual care and then switch to CoMBI. Care staff receive training to apply CoMBI. Participants will be observed and assessed repeatedly using tools such as the Neuropsychiatric Inventory Questionnaire (NPI-Q) and Qualidem before and after CoMBI training. Personality questionnaires help identify core needs. Researchers measure changes in BPSD severity, caregiver burden, and quality of life over time. The study includes ongoing monitoring and repeated outcome measurements every four weeks during the transition from usual care to CoMBI.

Age: 60Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are exploring the feasibility and broad effectiveness of the Ronnie Gardiner Method (RGM) in Flemish psychogeriatric patients aged 60 and older admitted to a psychiatric clinic. This study aims to see if participating in RGM sessions can improve core executive functions, emotion regulation, and overall well-being. The study also investigates whether personality types and positive experiences with the method influence its success. There is no control group because all patients in the clinic receive treatment. The RGM is a music-based intervention developed by a Swedish jazz drummer, involving exercises called "choreoscores" that combine movements and sounds, guided by trained practitioners. Participants attend RGM training twice a week for 12 weeks, with each session lasting at least 45 minutes. The difficulty of the sessions can be adjusted based on participants' capabilities. Participants are assessed before starting, halfway through (after 6 weeks), and after completing the 12-week program. Evaluations include questionnaires and neuropsychological tests to measure changes in executive functions, emotion regulation, and mental well-being. Researchers also collect information on participants' experiences with RGM and personality traits to understand factors affecting the training's effectiveness. Screening includes cognitive testing and reviewing medical history.

Age: 60Years +All GendersPhase Not Applicable
1 location
V

Actively Recruiting

Researchers are collecting data on patients with peripheral arterial occlusive disease (PAOD) who will be treated with the VITUS peripheral drug-coated dilatation catheter. This study aims to monitor the long-term safety and effectiveness of this device when used as part of routine clinical care. The study includes approximately 284 patients from around 15 centers in Europe, focusing on those undergoing percutaneous transluminal angioplasty (PTA) with this specific catheter. Participants receive treatment with a paclitaxel drug-coated balloon during angioplasty to address symptomatic peripheral arterial disease. Treatments follow the Instructions for Use and physician decisions. The treated lesion should be shorter than the nominal balloon length, but multiple overlapping balloons can be used for longer lesions to ensure full coverage. The registry records data over three years, with follow-ups immediately after the procedure, then at 30 days, 6 months, 12 months, 24 months, and 36 months. During the study, patients will have follow-up visits either by phone or in person to assess their health and treatment outcomes. Researchers monitor major adverse events at 30 days and 12 months after the procedure, as well as the occurrence of clinically driven target lesion revascularization at 12 months. The study ends when all patients complete the 36-month follow-up period, providing valuable information on the device's safety and performance in everyday clinical settings.

Age: 18Years +All Genders
13 locations
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