Participation in thrombEVAL I

thrombEVAL I included people who were receiving oral anticoagulation therapy and were treated during a hospital stay at one of the participating study centres. thrombEVAL I was an observational study, meaning that participation did not result in any changes to medical treatment. At the beginning of the study, participants attended a personal interview at the respective study centre. Information was collected on pre-existing and coexisting medical conditions, medication use, potential risk factors and previous treatment with oral anticoagulants. In addition, complications and hospital stays were recorded, anticoagulation records were reviewed, and participants completed a questionnaire about their experiences with medical care. The initial assessment took approximately 15 minutes. About one year after enrolment, participants took part in a further telephone interview lasting approximately 15 minutes, during which they were asked about their current health status and any complications or hospital stays. Long-term follow-up continued for up to five years.
 

Participation in thrombEVAL II

thrombEVAL II investigated the care of patients provided by a specialised, telemedicine-supported anticoagulation service. As part of their oral anticoagulation therapy, participants were supported by specially trained staff. Medication doses were individually determined based on current coagulation values and other relevant medical information. Before participating, patients had a detailed consultation with a physician. As part of the study, medical treatment data were documented in a standardised manner and scientifically analysed. Additional measurements included blood pressure, resting heart rate, body weight and height. Participants also answered questions about their everyday lives, quality of life, satisfaction and experiences with medical care. The additional time required for study participation was approximately 60 minutes in total, spread across various assessments during treatment. Individual participation in the study lasted up to 15 months. Care provided by the anticoagulation service included regular monitoring of blood coagulation, documentation of current medications and changes in health status, and individual adjustment of medication doses. The anticoagulation service also provided advice regarding planned operations or other medical procedures. All other medical care continued to be provided by the participants’ general practitioners and specialists.