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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
This research aims to design and assess a tailored primary care intervention to help manage the burden of caring for patients living with Alzheimer's disease or related dementia. The study involves healthcare professionals, informal caregivers, and academic experts collaborating to develop an effective support approach. The process follows recommended methods for developing complex interventions, including expert consensus and ongoing evaluation. The study is carried out in two phases. The first phase uses a Delphi-modified consensus method where panels of caregivers, healthcare professionals, and academic experts review and score proposed intervention ideas over 3 to 4 rounds. Topics are retained, eliminated, or refined based on scoring and group discussions. In the second phase, the developed complex intervention will be offered to three territorial professional health communities (CPTS). Data on how many caregivers were offered, accepted, or refused the intervention will be collected, along with qualitative feedback from voluntary participants and health professionals. Participants will be involved through surveys, focus groups, and interviews to explore the acceptability and co-construction of the intervention. Quantitative and qualitative data will be gathered to monitor the intervention's impact and to adapt it as needed. The entire process is continuous and aims to produce a detailed, practical care support model reported according to recognized guidelines. The study's primary outcome is the description of this tailored intervention after 12 months.
Actively Recruiting
Researchers are evaluating the long-term safety and performance of hip hemiarthroplasty surgeries using Corin BiPolar-i shell combined with the Oceane+ or Meije Duo femoral stem. This post-market clinical follow-up (PMCF) study aims to collect data over a period of up to 10 years to support the use of these devices, especially due to limited existing data under the new Medical Device Regulation. The study focuses on conditions such as hip fractures, osteoarthritis, avascular necrosis of the hip, and femoral neck fractures where the acetabulum does not require replacement. The study involves hip hemiarthroplasty, a surgical procedure replacing half of the hip joint with Corin devices. Participants receive the BiPolar-i shell and a cemented femoral stem, either Oceane+ or Meije Duo. The study tracks outcomes following these surgeries over an extended period, with data collection planned for up to 10 years to assess device safety and performance. Participants will be followed for safety evaluations, including clinical, radiographic, and patient-reported outcomes. The primary outcome measure focuses on device safety two years after surgery. Subjects must attend follow-up visits according to the protocol, and researchers will monitor their recovery, complications, and device performance throughout the study duration. The study includes adults of all genders clinically suitable for hip hemiarthroplasty with Corin devices and involves informed consent and compliance with study procedures.