Feasibility Study

Researchers are evaluating a digital health intervention using a mobile application called "Pust Deg Bedre" (PDB) to support self-management in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD patients often experience symptoms like dyspnea, cough, and chronic mucus hypersecretion, which increase infection risks and exacerbate the disease. This study aims to explore the feasibility, patient and physiotherapist experiences, and implementation of the PDB app in managing these symptoms. The intervention involves physiotherapists providing patients with training on how to use the PDB app, which offers tailored breathing and airway clearance techniques based on clinical assessment. Patients will engage with the app's treatment plan over an 8-week period, with follow-up at 6 months. Adjustments to the treatment plan may be made during the intervention. The study includes qualitative interviews and video-recorded physiotherapy sessions to gain deeper insights into the interactions and experiences of patients and physiotherapists. Participants will be assessed through questionnaires and interviews at the end of the 8-week treatment and at the 6-month follow-up. Researchers will collect both quantitative and qualitative data, including health-related outcomes, adherence, adverse events, and patient satisfaction. Physiotherapists will also be followed up to explore the impact of participation on their clinical practice. The total study duration includes the initial intervention and a long-term follow-up, aiming to gather comprehensive information on the app's usefulness and acceptability.

Researchers are evaluating a 12-week home-based mobile health (mHealth) intervention called the Shining Star study, aimed at improving adherence to the 24-Hour Movement Guidelines among preschool-aged children (3-4 years old) who currently meet zero or one of the guidelines for physical activity, screen time, and sleep. The trial seeks to determine if the intervention increases the number of children meeting all three guidelines and if the program is feasible for parents to implement. This randomized controlled trial compares an intervention group using the app to a waitlist control group. Participants in the intervention group will use the Shining Star mobile app, which delivers weekly lessons and behavior-related goals through concise messages, gamification features, behavior trackers, and a parent forum. The control group will receive no intervention during the initial 12 weeks but will complete the same assessments as the intervention group. After 12 weeks, control group participants will gain access to the app and resources. Physical activity and sleep will be tracked with accelerometers, and parents will complete questionnaires. Children's physical activity, sedentary behavior, and sleep patterns will be assessed at baseline, 6 weeks, and 12 weeks using accelerometers. Parents will provide feedback on their child's movement behaviors, development, and app usability through questionnaires and weekly surveys. Additional measures include motor skills tests, cognition assessments, behavioral problems, executive function, and BMI. Data will be securely stored and analyzed to evaluate the intervention's impact and app feasibility over the 12-week period.

Researchers are studying the WE BEAT program, a 5-week online group-based wellbeing and skill-building program designed for adolescents aged 12 to 17 with moderate to severe congenital heart disease (CHD). The trial aims to see if this program helps participants become more resilient and improves their quality of life compared to usual care. It also examines potential links between participant-reported psychosocial data and clinical outcomes related to CHD. Participants will be randomly assigned to either the WE BEAT program or usual care. After completing the 5-week program, those in the intervention group will be further randomized to receive either a single booster session at week 18 or no booster session. The booster session reviews all skills introduced in the original program. The usual care group will continue their standard treatment without the WE BEAT program. Throughout the approximately 6-month study, all participants will complete four online surveys and provide hair and saliva samples at multiple timepoints. Some may also volunteer for optional blood and urine samples. Researchers will measure resilience using the Connor-Davidson Resilience Scale and assess various psychosocial and biological markers of stress and wellbeing. The study includes ongoing data collection at baseline, week 5, week 18, and week 30 to track outcomes and safety.

Researchers are evaluating the "SIESTA" intervention, a culturally tailored sleep hygiene program designed to improve sleep health in urban Latino middle school children aged 11 to 13 years who typically sleep 9 hours or less per night. The study aims to see if SIESTA participants have better sleep outcomes, improved sleep hygiene behaviors, and less sleep-related impairment compared to a control group receiving general health education. This large-scale randomized trial will enroll 300 children from Providence, Rhode Island and San Juan, Puerto Rico. The SIESTA intervention involves four one-hour group sessions conducted remotely by a trained facilitator, plus two 90-minute individualized sessions with the child and caregiver delivered at home. The program focuses on key sleep hygiene principles tailored to urban Latino children, including sleep duration, sleep environment, and strategies to improve sleep quality. The control group participates in four group sessions on basic sleep hygiene and general child health topics, along with two individualized sessions, but without tailored behavioral strategies. Participants will complete surveys at baseline, end of treatment, and at 4, 8, and 12 months post-intervention. They will wear electronic sleep watches to objectively track sleep duration and quality throughout the study. Researchers will assess primary outcomes such as sleep duration and efficiency and secondary outcomes including sleep disturbances and sleep-related impairments. The study also involves a process evaluation to understand program reach, adoption, and implementation in urban school settings. Total participation lasts about 14 months.

Researchers are evaluating an artificial intelligence (AI) model designed to help doctors predict patient diagnoses and outcomes, such as survival and length of hospital stay. This prospective study uses real-time, multimodal health data from hospital electronic health records, including labs, vital signs, medical history, and imaging. The goal is to improve the accuracy and speed of diagnosis and treatment in real-world hospital settings, enhancing patient care. The study involves patients admitted to various hospital departments, including ICU, general wards, emergency, and outpatient services. The AI system integrates multiple types of patient data to support clinical decision-making while patients continue to receive standard examinations and care. This observational study follows patients to compare the AI model's performance with standard practice over time. Participants will be tracked using electronic health records and hospital data to assess outcomes such as diagnostic accuracy, hospital resource use, and adverse event rates over one year. Researchers will measure improvements in hospital efficiency, patient outcomes, and population health impact. The study aims to provide real-world evidence of how AI may assist medical decision-making across hospital settings.

This trial investigates the feasibility of a parenting program called ATTACH(TM) designed to improve mentalizing skills—the ability to reflect on thoughts and feelings—in parents of children aged 0 to 5 years. It aims to find out if parents are willing to participate in the program, complete most sessions, and whether the program increases parental mentalizing skills compared to usual treatment. The study is conducted in three municipal family treatment centers and focuses on families receiving support for psychosocial problems. Participants will be randomly assigned to one of two groups: one group will receive the 10-session ATTACH(TM) program in addition to the usual family support services, while the other group will receive only the usual care provided by local social and healthcare systems. ATTACH involves weekly 45-60 minute sessions that include video reviews of parent-child interactions, reflection exercises on hypothetical and real-life situations, and use of supportive materials. Usual care may include various parenting support and therapeutic services tailored to family needs. During the study, parents will complete surveys, interviews, and video observations at the start and five months after starting treatment to assess mentalizing skills and other family and child outcomes. The research team will also follow up one year later to check on ongoing treatment or support needs. The study measures include parental reflective functioning, parent-child interaction quality, child development, parental depression, and family functioning among others.

Researchers are evaluating a behavioral health program called Interventions for Stressful Transitions in Later Life (InSTILL) designed for short-stay skilled nursing facility residents and their primary care partners. The study aims to determine if the InSTILL program is feasible, satisfactory, and helpful compared to minimally enhanced usual care. Participants will be randomly assigned to either the InSTILL program or usual care and will complete assessments at three timepoints along with a brief exit interview. The InSTILL program includes eight sessions delivered twice a week over about four weeks, which can be attended in person or remotely. Both the resident and their care partner participate together in all sessions led by a trained clinician. The comparison group receives a psychoeducational pamphlet and enhanced referrals for community support resources. Participants will be involved in assessments before, immediately after, and one month following the intervention. These include questionnaires on treatment credibility, satisfaction, adherence, feasibility of recruitment and data collection, clinician fidelity, adverse events, and acceptability. Secondary measures assess depression symptoms, anxiety, resilience, relationship quality, preparedness for future care, and other psychological and health outcomes. The study will monitor these outcomes to better understand the program’s impact and feasibility over time.

Researchers are evaluating two new ways to help people who have had a stroke lower their blood pressure, which is the leading cause of having another stroke and can harm brain health. This study aims to compare home blood pressure monitoring alone with a combination of home monitoring plus group medical visits conducted virtually. The goal is to improve secondary stroke prevention and support brain recovery by testing these two approaches in stroke survivors with hypertension. Participants will be assigned randomly to one of two groups. One group will receive instructions for home blood pressure monitoring only, while the other group will receive the same home monitoring plus participate in virtual group medical visits that provide education and peer support. The study uses a Hybrid Type 1 randomized control trial design to test the effectiveness of these interventions and will measure adoption and acceptability using established research frameworks. During the study, participants will monitor their blood pressure at home and take part in virtual group sessions if assigned to that group. Researchers will assess blood pressure control, focusing on systolic blood pressure measured at three months. The study also includes evaluating how well the interventions are adopted and accepted by participants. Participants must have internet access and a primary care doctor at Massachusetts General Hospital to take part. The study will run until April 2028, with ongoing monitoring and data collection throughout the trial.

Patients with ischemic heart disease who are scheduled for elective coronary artery bypass graft (CABG) surgery often face challenges such as advanced age, frailty, other health conditions, and physical inactivity. These factors, along with the physical and psychological stress of surgery, can affect recovery after the operation. Traditionally, efforts to improve surgical outcomes focus on care during and after surgery, but the waiting period before surgery may offer a valuable opportunity for prehabilitation to boost patients' ability to recover. The study evaluates the feasibility of a home-based multimodal prehabilitation program for patients awaiting elective CABG surgery. This program combines web-based supervised exercise sessions, nutritional guidance, psychological support, and advice on smoking and alcohol cessation. Patients in the intervention group receive these additional preoperative supports alongside usual care, while the control group receives usual care alone. The intervention includes three exercise sessions per week via a tablet and weekly phone consultations with a specialized nurse. Participants will be involved from enrollment until 30 days after surgery. Researchers will monitor recruitment, retention, adherence to the prehabilitation program, and safety throughout the preoperative period. Various assessments will occur at baseline, the day before surgery, and 30 days post-surgery, including exercise capacity, muscle strength, nutritional status, quality of life, anxiety, depression, and lifestyle factors such as tobacco and alcohol use. The study aims to inform a larger future trial and improve patient outcomes using the pre-surgery period.

Researchers are evaluating SHAReClinic, a national virtual Sexual Health and Rehabilitation eClinic designed to support prostate cancer patients and their partners. This observational study aims to assess SHAReClinic's impact on improving sexual function, satisfaction, relational intimacy, and overall sexual health after prostate cancer treatment. The goal is to determine SHAReClinic's effectiveness across multiple cancer centers and its role in supporting long-term sexual well-being for patients and couples. Participants will have access to guided education modules and sexual health counseling through SHAReClinic as part of their usual care. The program includes a bio-medical component focused on erectile rehabilitation and a psychological component to maintain or restore intimacy. The study follows patients from before treatment through 12 months post-treatment, with virtual clinic visits scheduled at key recovery milestones, including 6 weeks, 10 weeks, 4 months, 6 months, and 12 months after treatment. Participants will complete questionnaires at baseline, 6 weeks, 6 months, and 12 months to assess sexual function, distress, intimacy, and quality of life. Each virtual clinic visit lasts about 30 minutes and involves a sexual health coach who provides support via phone or video calls. Patients can also engage with a Q&A platform and request additional check-in calls. Researchers will monitor patient satisfaction, enrollment, adherence, and data quality throughout the study, which facilitates ongoing evaluation of SHAReClinic's role in sexual health rehabilitation.