Clinical trials

The objective of this trial is to evaluate the effectiveness of a mobile app-based motor skills intervention (DigiKids RCT) on motor competence, physical activity, and perceived motor competence compared with standard school practices in primary school children. In addition, the study will examine other factors such as child-specific and family-related factors that might influence the findings.

The purpose of this study is to collect data on blood circulation using a multi-frequency impedance plethysmography device developed in the ThrombUS+ project. Impedance plethysmography (IPG) is a non-invasive method that measures changes in blood volume using electrodes placed on the skin. The collected data will be used for device development, the improvement of diagnostic data analysis methods, and AI training. A total of 40 participants will be recruited for this study, with 20 healthy volunteers in Tampere University and 20 patients undergoing thrombolytic therapy for DVT at Tampere University Hospital.

The goal of this pilot trial is to learn whether a six-month physical activity program tailored for older family caregivers can be successfully delivered and whether participants are willing and able to take part in it. The study will also explore possible effects of the programme on physical activity, physical function, health, and well-being. The main questions it aims to answer are: * Can enough participants be recruited to the study? * Do participants adhere to the study and complete follow-up assessments? * How often do participants take part in the program activities? * How acceptable and useful do participants find the program? * What are the possible effects of the programme on physical activity, health, and wellbeing. Researchers will compare the physical activity program with a control group that receives health information and education about healthy ageing. Participants will: * Complete health, physical functioning, and questionnaire assessments at the beginning of the study, after 6 months, and after 12 months * Wear an activity monitor on their wrist for 7 days and nights at the beginning of the study and after 6 months * Will be randomly assigned to either a six-month physical activity program designed for older family caregivers, or a control group that receives health information and education about healthy ageing. * If assigned to the physical activity program, participants will take part in weekly group-based and remote exercise sessions for 6 months. * Provide feedback about their experiences of the program

The aim of this study is to develop, implement, and evaluate the effects of a virtual ECG rhythm intervention on the interpretation and competence of cardiology nurses in Finnish university hospitals. The virtual ECG rhythm intervention consists of a virtual animation component and a virtual simulation component, both incorporating cardiological patient cases with corresponding ECG rhythms. The virtual animation includes educational content on a total of 31 different ECG rhythms, as well as a virtual simulation containing 6-8 different cardiological patient cases with ECG rhythms (covering 11 distinct rhythms). The study employs a quasi-experimental design. Cardiology nurses are divided into two groups based on hospital: an intervention group and a control group. In this study, data will first be collected for the virtual animation component during 2026-2027, followed by data collection for the virtual simulation component during 2027-2028. A baseline measurement of ECG interpretation and competence will be conducted for both groups (n = 508) using an online survey (LimeSurvey) prior to the intervention. The same measurement schedule will be applied to the virtual simulation component during the 2027-2028 data collection period. In this study, three (3) reminder letters will be sent at weekly intervals to encourage participation in the study, its surveys, and the virtual interventions. These reminder messages will be distributed via email by unit managers or equivalent personnel in each hospital to the participants. The virtual intervention will be delivered online via a web service (GitHub) link. Research data on ECG interpretation and competence will be collected using an ECG interpretation measurement instrument administered through an electronic survey (LimeSurvey). The ECG interpretation instrument was previously developed by the researcher and includes ECG recordings from real patient cases, for which prior permission has been obtained in accordance with the practices of a cardiac care unit in a central hospital. The instrument has been partially updated in terms of ECG rhythms, with additional new ECG recordings included. Permission for the new ECG recordings was obtained in April 2023 from a Finnish wellbeing services county. The instrument also includes ECG recordings from a simulation monitor display. The ECG interpretation instrument begins with 14 background questions. It includes five questions assessing ECG competence and currently contains 31 ECG interpretation questions, compared to the previous 21 items. Additionally, the end of the instrument includes seven questions assessing the experiences of participants in the intervention group regarding the virtual intervention. These implementation methods aim to control for the potential influence of external variables, as the intervention and survey are identical for all participants. This consistency could not be guaranteed if the virtual ECG interpretation intervention were delivered, for example, as a traditional theory-based lecture. The results of the study will be analyzed using statistical methods. The findings can be utilized, for example, in the development of ECG rhythm interpretation and competence training programs for cardiology nurses.

The AFFELECT -study compares two types of treatment modalities for acute atrial fibrillation or flutter for patients in whom rhythm control is desirable. The main purpose is to observe if these arrhythmias can be safely treated electively (within 5-9 days). All patients are recruited in the emergency department. Patients must be in good clinical condition so that they can be discharged regardless to which treatment modality is randomly selected to them. Patients randomized to conventional care are treated conventionally which means acute rhythm control is applied by electrical or medical cardioversion in the emergency department (within 48 hours of onset of the arrhythmia). Patients randomized to elective care are discharged immediately after adequate temporary rhythm control is assured. All patients will visit a cardiologist out-patient clinic at approximately one week after the emergency room visit. Patients randomized to elective treatment and still in atrial fibrillation or in atrial flutter will be restored to sinus rhythm by electrical or medical cardioversion at the out-patient clinic. Cardiovascular status and treatment options are evaluated for all patients. Anticoagulation is managed according existing guidelines for all patients. Due to possibility of delayed cardioversion in the interventional group (elective care group), all patients receive anticoagulation before the out-patient clinic despite their thromboembolic risk. All patients who have not received adequate anticoagulation for three weeks prior to the delayed cardioversion will undergo a transesophageal cardiac ultrasound to ensure they are not in excess risk for thromboembolic events. Patients randomized to elective treatment have the possibility to opt-out and undergo acute cardioversion if their symptoms are unmanageable during the first week before the out-patient clinical. All patients are monitored for their symptoms by a standardized quality-of-life questionnaire and for possibly required acute medical interventions during the first week and one month after the out-patient clinic. After one month, all patients undergo an electrocardiography (ECG) to ensure the maintenance of normal rhythm in both treatment groups. After the months follow-up all patients are subsequently monitored for a maximum of five years for need of medical interventions due to atrial fibrillation of atrial flutter. New antiarrhythmics such as flecainide are not prescribed during the first month.

This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.

Assessment of a novel diagnostic method for screening and diagnosing chronic limb-threatening ischemia (CLTI). Using hyperspectral and thermal imaging, the perfusion and oxygenation in the lower limbs will be studied in healthy and unhealthy individuals.

The summary is available at --\> https://www.finnatopy.fi/summary

This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention.

Prospective clinical study with two parts: PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD) subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of high-risk stable CHD subjects PART A: 12 000 subjects with stable CHD PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or personalised prevention program (PPP) i.e. 1000 subjects per arm. Study purpose is to assess the clinical value and cost-effectiveness of a personalised prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to prospectively validate risk screening biomarkers