Weissenthurm, Germany

The NUTRIOME Study - a Data-driven Precision Nutrition Intervention

Clinical Investigation of Proton Treatment in Hodgkin Lymphoma Patients - PRO-Hodgkin

Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial

A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis

This is a 12-month, multicentre, open-label, non-randomized, interventional single-arm study to assess the course of synovial hypertrophy in previously treated patients ≥12 years of age with moderate or severe haemophilia A achieving high sustained FVIII levels provided by weekly efanesoctocog alfa prophylaxis. To be eligible to enroll in the study, patients must have existing synovial hypertrophy in at least one of the 6 index joints (ankles, elbows, and knees) as assessed by the HEAD-US scoring system. A retrospective data collection on patients' haemophilia, medical, and surgical history will be performed, including a 12-month history of previous treatment and treated bleeding episodes. The study will start with the Screening Visit, which can be conducted up to 45 days prior to the Baseline Visit (Day 1), to check whether the patient fulfils all the inclusion criteria and none of the exclusion criteria. Patients will have an ultrasound examination of all non-prosthetic index joints at screening. The ultrasound images will be sent for central reading assessment using the HEAD-US scoring system to determine whether the patient has at least one eligible joint required for study inclusion. Once it is confirmed that a patient is eligible for inclusion, he/she will be enrolled in the study and attend a mix of on-site visits and phone call visits. The results from central reading assessment will be sent to the study sites and included in the baseline characteristics of the patients. MRI examinations can be conducted at the Baseline Visit or up to 28 days afterwards. Images from MRI will also be sent for central reading assessment using the International Prophylaxis Study Group (IPSG) MRI scale. The central reading assessment will be sent to the study sites and included in the patient data. Patients will be treated with once-weekly efanesoctocog alfa (50 IU/kg) prophylaxis and will complete the patient diary with their dosing and bleeding information. Assessments will be conducted during the on-site visits, which will occur every 6 months, and during phone call visits, which will occur halfway between these visits. A Safety Follow-up Call will be conducted 14 (+7) days after the End of Treatment (EoT) Visit. Ultrasound and MRI will be used to detect changes in synovial hypertrophy in index joints of patients. The primary endpoint of improvement in existing synovial hypertrophy from baseline to Month 12 as well as the key secondary endpoint of detection of new synovial hypertrophy and change in joint health status from baseline to Month 6 or Month 12 will be assessed using ultrasound and the HEAD-US scoring system. To obtain 100 eligible index joints, the target is to enroll approximately 35 patients.

A Municipality Implemented Behavioural Intervention to Improve Quality of Life Among Older Adults

Development of the intervention: 'Light, activity and sleep in my daily life' The 'Light, activity and sleep in my daily life' (LAS) intervention directed at older adults was developed to promote wellbeing through increased physical activity, enhanced mood and sleep, and improved lighting and darkness conditions at home. The intervention focuses on health promotion through changes to routines (light-related behaviour, outdoor physical activity and sleep behaviour) and environmental proactivity. The latter refers to persons who modify their environments to live a healthy and independent life. Environmental modifications include interior lighting, filtering daylight and blocking light at night, without risking accidents when getting up at night, and furniture arrangement. The intervention is complex in that it considers multiple factors (e.g., light-related behaviour, physical activity and sleep behaviour) and components (e.g., cognitive goal setting and implementation. The intervention addresses self-identified needs, which can make it more effective. The intervention is delivered as a web-based course on a digital platform and includes one introductory physical meeting and three additional physical meetings. Course material is placed in nine modules covering electric lighting, daylight, physical activity outdoors and sleep. Each completed module ends with a brief online evaluation. Besides online material, the course includes a test kit containing light bulbs, a sleep mask, a checklist for the room inventory, a cap, a notebook, and a sleep diary. The purpose of the test kit is to encourage experimentation and provide handouts and printed copies to facilitate the completion of assignments. In 2021-2022 usability evaluations of a first version were conducted in a full-scale model of an apartment by two sets of participants: in a first round by experts and in a second round by pensioners representing the target users (community-dwelling adults aged 70 and over). Intervention content and design features were refined based on their feedback. In autumn 2022, intervention usability and study feasibility were evaluated in real-world homes by eight participants aged 71-84 (27). The conclusion was that only minor changes to the intervention were needed based on participants' feedback. Regarding the locality for the physical meetings, the researchers found the municipality's senior citizen meeting point suitable for the purpose, and participants appreciated that meetings were at the same place. One finding was the need to extend the time for recruitment, and advertising in the local newspapers should be considered to reach a wider group of potential volunteers. Based on the study findings from the field, the following design changes were made to the online intervention content: the weekly evaluation form was revised so intervention participants can provide textual feedback to the course leader/interventionist; instructions for downloading the light meter app to the phone were revised; and text links were updated. This pilot case study aims to evaluate the usability and acceptance of the LAS intervention, the intervention outcomes and whether changes to routines are sustained. In addition, perceived enablers and inhibitors to daytime outdoor walking will be identified. The primary objectives are as follows: 1. To evaluate the usability and usefulness of the intervention, that is, determine if the online intervention content is easy to use and the intervention is useful for older adults 70 and over. 2. To evaluate the acceptance of intervention delivery procedures (locality of physical meetings, recruitment) to municipal staff (potential service providers). 3. To identify motivation/capabilities/opportunities relating to outdoor physical activity (e.g., perceived enablers and inhibitors to daytime outdoor walking). 4. To develop further training material for future course leaders/interventionists in dialogue with the municipal partners. A secondary objective is to gain insight into the potential effectiveness of the intervention in terms of activity and rest patterns, mood, sleep quality, behavioural skills and quality of life.

Mobilisation and Breathing Exercises After Abdominal Surgery at Sahlgrenska University Hospital

Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard® Therapy for Prevention CSA-AKI

A New Cancer Rehabilitation Process for Chemotherapy-Induced Foot Neuropathy Using Orthopedic Devices

Background and Rationale This study aims to develop and evaluate a structured multidisciplinary rehabilitation process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet. The project establishes a new collaboration between the Oncology Department and the Department of Orthopedic Technology at Sahlgrenska University Hospital, integrating an orthopedic approach into cancer rehabilitation. Chemotherapy-induced peripheral neuropathy is a common side effect of chemotherapy, affecting 50-90% of patients undergoing cancer treatment. Symptoms such as numbness, tingling, pain, and sensory loss in the feet can lead to chronic discomfort, impaired balance, and reduced quality of life. Despite its prevalence, there are no standardized guidelines for grading or managing chemotherapy-induced peripheral neuropathy within rehabilitation. Additionally, structured follow-up for chemotherapy-induced peripheral neuropathy after chemotherapy is lacking in Sweden, and there are limited effective treatment options available. This research project aims to develop a structured process for assessing and managing chemotherapy-induced peripheral neuropathy in the feet and to evaluate two orthopedic interventions: - Current standard treatment - customized insoles and orthopedic shoes. - A novel intervention - a silicone orthosis, designed as a soft, sock-like device for indoor use. Although silicone orthoses have been introduced in limited clinical settings in Sweden, their effectiveness for chemotherapy-induced peripheral neuropathy remains untested. This study seeks to evaluate whether this new intervention can alleviate symptoms and improve mobility and quality of life for breast cancer patients experiencing chemotherapy-induced peripheral neuropathy . Study Objectives The overall aim is to establish and evaluate a new process for assessing and alleviating symptoms in the feet through orthopedic technology. Specifically, the study will: - Compare the effectiveness of two orthopedic interventions (custom insoles vs. silicone orthosis). - Investigate patient-reported outcomes regarding symptom relief, quality of life, and functional mobility. Study Design and Methodology The study consists of a pilot phase with, followed by a potential randomized controlled trial if preliminary results are promising. This pilot study will include 40 participants, divided equally between the two intervention groups. It is conducted at Sahlgrenska University Hospital, involving a multidisciplinary collaboration between the Oncology Department and the Orthopedic Technology Department . Step 1: Diagnosis and Assessment Patients with chemotherapy-induced peripheral neuropathy in the lower extremities (feet) following breast cancer treatment will be assessed using a standardized grading system based on the Common Terminology Criteria for Adverse Events as well as a symptom questionnaire. Patients will also complete self-reported quality-of-life assessments as well as the EQ-5D scale and undergo 3D foot scanning to measure foot morphology and structural differences compared to the general population. Medical records will be reviewed to collect demographic and clinical variables (age, cancer status, chemotherapy regimen, comorbidities, smoking status, Body Mass Index). Step 2: Orthopedic Interventions Patients will be randomly assigned to one of two intervention groups: Group 1: Receives customized orthopedic insoles and shoes, the current standard treatment for diabetic neuropathy. Group 2: Receives a silicone orthosis, a novel sock-like support designed for indoor use. All participants will receive guidance on footwear selection and be provided with seamless socks to minimize pressure on sensitive areas. All patients will also be examined with - D-Foot: A validated and reliable instrument for structured foot examination, primarily used in diabetic foot assessments. - 3D foot scanning (Volumental scanner): Provides highly accurate foot measurements with a ±1 mm error margin. Step 3: Activity Monitoring To objectively assess mobility and functional changes, patients will wear an activity tracker (Active Pal) attached to their leg using skin-friendly tape for two weeks. The device records data on: - Time spent sitting, standing, walking, or lying down. - Step count and movement patterns. Patients in the silicone orthosis group will also maintain a daily usage diary to document how often they wear the device. Step 4: Follow-Up and Outcome Evaluation Follow-up assessments will occur 3-6 weeks post-intervention, conducted by oncology nurse or doctor via: - Repeat symptom grading (CTCAE). - Self-reported questionnaires on foot health and quality of life. - Semistructured interviews evaluating patients' experiences with their assigned intervention. Interviews will explore: - Perceived symptom relief and comfort. - Impact on daily activities and mobility. - Satisfaction with the provided intervention. - The follow-up can be conducted in person, via phone, or digitally and is estimated to take approximately 45 minutes. Scientific Questions The study aims to answer the following key research questions: - What is the prevalence and severity of chemotherapy-induced peripheral neuropathy in the feet among the patients? - How does chemotherapy-induced peripheral neuropathy affect self-reported quality of life (EQ-5D scores)? - What is the foot status (e.g., structural and functional characteristics) in affected patients? - Are there foot morphology differences between chemotherapy-induced peripheral neuropathy patients and the general female population? - Does the type of orthopedic aid influence activity levels and mobility? - How does chemotherapy-induced peripheral neuropathy impact patients' daily lives? - Are there differences in patient experience and perceived effectiveness between the two orthopedic interventions? Expected Impact If successful, this study will: - Provide new insights into the effectiveness of orthopedic aids for chemotherapy-induced peripheral neuropathy -related foot symptoms. - Establish a structured assessment process for chemotherapy-induced peripheral neuropathy in oncology rehabilitation. - Improve patient quality of life by offering evidence-based interventions for symptom relief. - Lay the groundwork for a larger randomized controlled trial to confirm findings and influence future clinical guidelines. By bridging the gap between oncology and orthopedic technology, this project aims to enhance rehabilitation strategies for cancer survivors dealing with long-term neuropathic complications.

Digital Delivery of Person-centered Transitional Care

Medical and surgical advances have significantly increased the life expectancy of individuals with congenital and pediatric-onset diseases, often resulting in chronic conditions. Effective lifetime care is crucial, especially during the transition from pediatric to adult care. Transition is a process where adolescents with chronic conditions are prepared to manage their health and life as they move to adult healthcare environments. Transition programs are designed to assist in this preparation, and over the past decade, several randomized-controlled trials (RCTs) have demonstrated the effectiveness of such programs in improving outcomes like self-management, knowledge of the condition, clinic attendance, and satisfaction with care. In Sweden, the STEPSTONES (Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS) project is evaluating a person-centered transition program tailored for young individuals with chronic conditions. The project has focused on conditions like congenital heart disease and type 1 diabetes through RCTs and is now exploring a digital adaptation called Digi-STEPSTONES, which aims to deliver the transition program remotely to improve accessibility and continuity of care. PURPOSE AND AIMS The main goal of this project is to evaluate the effectiveness of a digitally delivered, person-centered transition program for adolescents with asthma/allergy and those who have undergone a solid organ transplant in a real-world setting. The specific objectives are: - To investigate the non-inferiority of the digital delivery compared to in-person delivery. - To evaluate the implementation process of the digital transition program. SIGNIFICANCE AND NOVELTY Digi-STEPSTONES aligns with person-centered care principles by supporting shared decision-making and empowering adolescents to actively participate in their healthcare. This project is novel as it is the first to provide evidence on the effectiveness of a digitally delivered person-centered transition program, covering multiple conditions, which enhances the generalizability of the findings. RESEARCH DESIGN AND METHODS To achieve the project's objectives, two studies will be conducted: Study 1: Comparative Effectiveness Research (Non-Inferiority Trial) A two-arm, non-inferiority study using a causal inference methodology will be performed. Arm A involves a digital delivery of the transition program, while Arm B is a historical cohort from previous RCTs that received in-person delivery. The STEPSTONES transition program includes eight components implemented in five steps, and the intervention will be delivered via the "Mitt vårdmöte" platform, already in use for digital healthcare appointments in Sweden. Assessments will be made at ages 16 and 18.5, focusing on primary outcomes like patient empowerment and secondary outcomes like transition readiness, quality of life, and health literacy. Study 2: Evaluation of the Implementation of the Digital Transition Program A mixed methods approach will be used, combining quantitative and qualitative methods. Adolescents who participated in the digital program and healthcare providers will be included. The evaluation will focus on the intervention's reach, fidelity, perceived barriers, facilitators, usability, and user-friendliness of the digital platform. TIMEPLAN The Digi-STEPSTONES project will be executed through six work packages, covering managerial, developmental, implementation, research, and reporting tasks, starting in 2023. Ethical Approval The project has received ethical approval (2022-05394-01-351139, 2023-01-13). By delivering the transition program digitally, Digi-STEPSTONES aims to reduce the burden on young patients, particularly those living in remote areas, and ensure that they receive the necessary transitional care. The project will contribute to Sweden's healthcare objectives by leveraging digital solutions to provide accessible, equitable, and high-quality care. RESEARCH DESIGN AND METHODS To address the specific objectives of this project, 2 studies will be conducted: Objective 1 Study 1: Comparative effectiveness research: Non-inferiority trial Design: A two-arm, comparative, non-inferiority study, using a causal inference methodology will be performed. Arm A involves a pre-test/post-test design where individuals will participate in the digital delivery of the transition program. Arm B is a historical comparison cohort that includes participants from two previous RCTs who received the intervention in-person. Participants/inclusion criteria: Arm A: - Literate, Swedish-speaking adolescents with asthma/allergy or went through a solid organ transplantation aged minimum 15 years. Their parents will be invited to fill out a questionnaire (proxy). Arm B: - Literate, Swedish-speaking adolescents with asthma/allergy or went through a solid organ transplantation aged minimum 15 years. Their parents will be invited to fill out a questionnaire (proxy). Sample size calculation: Arm A: approximately 100 patients will be recruited consecutively Arm B: the approximate sample for individuals who received the intervention in-person is of approximately 120. Exclusion criteria: - Non literate - Not Swedish speaking - Cognitive impairment Intervention: The STEPSTONES transition program is a multi-component intervention comprising 8 components: a) a transition coordinator (TC); b) information and education about the condition and treatment, health behavior, dealing with school and friends; c) availability by telephone; d) information about and contact with the adult program; e) guidance of parents; f) meeting with peers; g) person-centered transition plan; and h) the actual transfer to the adult program 15,16. These components are implemented in five steps: (1) first outpatient visit with TC; (2) second outpatient visit with TC; (3) information and peer-to-peer session for adolescents and their parents; (4) individualized transfer plan; and (5) actual transfer (Figure 2). The intervention will be delivered through the "Mitt vård mote" platform, which is currently being used across Sweden to undertake digital healthcare appointments. The HEADDDSS (home, education, activity, diet, drugs, depression, sex, safety) adolescent health interview is a cornerstone of the intervention. The intervention will be performed by specialized nurses of the respective pediatric care units, after being trained to become TC. The core of the STEPSTONES transition program remains the same for the present project, except that the delivery will be digital. Variables and measurement: Assessments are planned at the age of 16 years (Time 0 - baseline ) and 18.5 years (Time 1- endpoint). The primary outcome is Patient Empowerment, using the Gothenburg Young Persons Empowerment Scale. Secondary outcomes are transition readiness; quality of life; and satisfaction with transition. In parents, the proxy transition readiness is measured. Procedure of patient recruitment, data collection and data management: Patients who are eligible for inclusion will be approached by letter at the age of 16 years. In a subsequent telephone call, both the adolescents and their parents will be informed verbally about the study. Patients will only be included if the adolescent, who is a minor at the time of inclusion, provides written informed assent, and the parents/guardians provide written informed consent. Patients will be asked to complete a set of online questionnaires (eCRF) online. To increase the response rate, a modified Dillman procedure will be used to minimize non-response, same procedure as in prior STEPSTONES trials. Reminders will be sent after three, five and seven weeks. Statistical analysis: Propensity score weighting will be used as a method of causal inference. It mimics an RCT design and reduces comparative bias. After propensity weighting, the groups are compared by applying a linear model with doubly robust estimations. A one-sided p<0.025 will be used as the cutoff for statistical significance, because non-inferiority is hypothesized. Objective 2 Study 2: Evaluation of the implementation of the digital transition program Design: for this evaluation, a mixed methods approach will be used, meaning a combination of quantitative and qualitative methods will be used. Participants: adolescents who participated in the digital transition program as well as the nurses in charge of delivering the transition program (i.e., transition coordinators) will be included in this section. Additionally, personal from the adult healthcare unit will be interviewed. Sample size: all participants from study 1 will be included in the quantitative assessment of this study. In the qualitative assessment, between 10-15 adolescents and around 10 healthcare providers will be interviewed. Data collection: to describe the intervention's reach and fidelity, information on the number of participants that took part in the different components will be monitored. To identify perceived barriers and facilitators, as well as intervention fidelity, both the adolescents and healthcare providers will be interviewed individually. To evaluate the usability and user friendliness of the digital platform, a questionnaire will be answered. This questionnaire will be answered once they have finalized the transition program, meaning it will be included in the set of questionnaires the participants answer in study when they are 18,5 years. Lastly, a percentage of the digital meetings will be audio recorded and the care plans related to the intervention will be studied to understand the mechanism of delivery.

Personalized Metabolic Responses to Rapid, Slow and Resistant Starch

Up to 400 men and women with overweight or obesity will be invited for screening. Participants will provide stool-, saliva-, and fasting blood samples, alongside undergoing anthropometric measurements. Gut microbiota will be analyzed from stool samples, while saliva samples will be used to determine AMY1 copy number. This data will then be used to categorize participants into four distinct groups, based on high or low Prevotella abundance and high or low AMY1 copy number. Participants in all four groups will undergo a three-way cross-over feeding regime containing three different types of starch: A) resistant starch (RS), B) slow digestible starch (SDS) and C) rapid digestible starch (RDS). Each treatment will start with a "meal challenge day" at the clinic, where participants will eat test foods for breakfast, containing the different types of starch, followed by a standardized lunch. During the meal challenge day, blood samples will be collected over 7 hours along with continuous glucose monitoring, saliva sampling and self-reported appetite. During the following 14 days, participants will continue to consume the test foods A, B or C for lunch and dinner at home along with continuous glucose monitoring. The at home intervention will be followed up with a clinical visit, where fasting blood samples are taken before the breakfast from the meal challenge day is repeated. After the breakfast, participants will take finger prick blood samples from home during another 4 hours. Each intervention will be followed by a 14-day wash out period before the next treatment begins. The specific aims with the trial are: 1. To investigate differential metabolic responses (glycemia, blood lipids and inflammation biomarkers) in response to meal tolerance tests based on RS, SDS or RDS served for breakfast and dinner across individuals with high or low abundance of Prevotella and high or low AMY1 copy number. 2. To evaluate metabolic effects of chronic consumption of RS and SDS versus RDS daily for two weeks across different enterotypes and in individuals with high or low AMY1 copy number. 3. To evaluate a non-invasive method to measure redox potential in fecal samples. In exploratory analyses, the associations between fecal redox potential and responses to different starches as well as microbiota and other biomarkers will be investigated.