Clinical Research Directory

The Fit With Us Study

The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.

Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke

The goal of this (cost)effectiveness study is to compare care as usual with OTHER-intervention in Cerebro Vascular Accident (CVA) older adults in Geriatric Rehabilitation (GR). The main question\[s\] it aims to answer are: 1. What is the effectiveness of OTHER, as compared to occupational therapy as usual (CAU), on improving the self-perceived performance in daily activities of community-dwelling older persons post-stroke over a 24-week period after initiation of OTHER or CAU, as measured longitudinally (at week 4, 13 and 26)? Secondary: 2. What is the effectiveness of OTHER on improving satisfaction with the perceived daily performance of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) 3. What is the effectiveness of OTHER on improving physical activity of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) 4. What is the effectiveness of OTHER on improving self-management of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) 5. How do persons post-stroke and OT's experience and how do they reflect on OTHER in supporting a sense of self-management, safety and improving daily functioning? (qualitative approach). 6. What factors influenced the intervention delivery and the perceived benefits in the OTHER study (process evaluation)? 1) monitoring treatment fidelity, barriers and facilitators for implementation; 2) gain insight into the impact of OTHER on the GR transition to home; 3) to gain insight into what stroke survivors and OT's think of OTHER. 4) how participants, and professionals experience and thoughts they have on the OTHER-intervention in supporting daily functioning and self-management Cost-effectiveness 7. What is the cost-effectiveness of OTHER on improving self-perceived performance in daily activities and Quality Adjusted Life Years (QALYs) of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) Participants will get the OTHER-intervention treatment given by de occupational therapist which consists of activity monitoring, coaching and videoconferencing to optimalise the transition from clinical care to home. Researchers will compare care as usual to see if there is a effect on improving the self-perceived performance in daily activities, self-management and improving physical activity .

Support for Physical Activity in Everyday Life With Parkinson's Disease

This study aims to determine the effects of a motor-cognitive exercise intervention, delivered in the home environment using eHealth methods, among people with Parkinson's disease. The intervention will support and motivate motor training, combined with cognitive training, aimed at attentional and executive functions, among people at mild-moderate disease stages. The main hypothesis is that unsupervised motor-cognitive training in the home environment using eHealth will lead to improvements in gait performance, increased physical activity levels and improved perceived health.

Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women

The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ). This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.

Dr Solitaire: Assessing Cognitive Performance Through Meaningful Play

To assess cognitive performance by means of the game of Solitaire. In this study, the investigators want to define relevant game metrics, when playing Solitaire, that may be indicative of cognitive performance.

Evaluating the Effectiveness of the GILL eHealth Intervention to Improve Physical Health and Lifestyle Behaviours in Patients With Severe Mental Illness

The aim of this study is to evaluate the effectiveness of the nurse-led GILL (Gezondheid in Lichaam en Leefstijl) eHealth intervention in patients with serious mental illness (SMI), compared to usual care. Expected is that the GILL eHealth intervention will be more effective than usual care in improving physical health and lifestyle behaviors. To evaluate this, we will perform a cluster randomized controlled trial with an embedded process evaluation of the implementation of the GILL intervention. 258 adult patients with serious mental illness and a body mass index of 27 or higher (overweight/obesity) will be included. The GILL eHealth intervention consists of two complementary modules for (a) somatic screening and (b) lifestyle promotion, resulting in a personalized somatic treatment and lifestyle plan. Trained mental health nurses and clinical nurse specialists will implement the intervention within the multidisciplinary treatment context, and will guide and support the patients in the promotion of their somatic health, including cardiometabolic risk management. The intervention will be compared to usual care, which includes treatment according to national guidelines. The outcome measures will be metabolic syndrome severity (primary), fitness, physical activity, lifestyle behaviors, quality of life, recovery, psychosocial functioning, health related self-efficacy and health care utilization after 1 year. The process evaluation focuses on the feasibility of the eHealth intervention, its acceptability for patients and health care providers (mainly mental health nurses and clinical nurse specialists), and barriers/facilitators to implementation.

Luchtbrug Junior: the Next Step

Rationale: The introduction of e-health in the monitoring and management of patients with chronic conditions can be beneficial and efficient. The introduction of an online monitoring and management tool, "Luchtbrug", for children 6-16 yrs of age with asthma while reducing 50% of visits to the outpatient clinic, results in similar or improved asthma control while reducing costs. It is highly likely that this concept of e-health is suitable for other chronic conditions. Therefore the aim of the study is to investigate the added value of online monitoring and management of children with preschool wheeze (2-6 yrs of age). Objective: To assess whether the number of symptom free days can be improved using online monitoring and disease management via Luchtbrug Junior, while reducing the number of outpatient clinic visits by 50% Study design: Prospective multicentre (n=6) randomised trial in which disease management via Luchtbrug Junior will be compared with usual care. Follow-up: 12 months. Study population: children aged 2-6 yrs with preschool wheezing (multiple episode of cough, wheeze and dyspnoea). Intervention (if applicable): Children will be randomised into usual care (n=135) or partly online care via Luchtbrug Junior (n = 135) Main study parameters/endpoints: Primary objective: Number of symptom free days (SFDs) based on the TRACK questionnaire, during the last four weeks of the study (measured at 12 months). Secondary objectives: Healthcare consumption: unscheduled visits Emergency Department (ED) or outpatient clinic, unscheduled phone calls, hospital admissions) Questionnaires into: Quality of Life (QoL), cost-effectiveness (direct and indirect costs), self-management of patients, adherence to treatment, satisfaction of parents/caregivers. Usual care consists of regular visits to the outpatient clinic every 3 months after starting the study. In between visits contact with the healthcare team is by telephone as needed. At 3, 6, 9 and 12 months, patients will be asked to complete the TRACK questionnaire. Online care using Luchtbrug Junior will include visits to the outpatient clinic every 6 months after starting the study. In between visits, parents/caregivers of the patient will be asked to answer the digital version of TRACK questionnaire monthly, therefore the parents/caregivers will received email-reminders. Appropriate feedback on their TRACK-scores will be provided by their healthcare team within two working days. Any interventions such as adjustment of treatment are at the judgment of the treating pediatrician. Therapy adherence will be monitored during the study by using smart inhalers.

Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects

Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.

Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up. This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.