PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional
The exercise instructions given in the PREPARE program are part of the standard treatment and care is taken to ensure that the exercises are done safely at home. The only research segment is measurement of the parameters and clinical outcomes." Patient Visits: 1. Recruitment/Enrollment (Visit 1 - coincide with PAC visit) Once informed consent is obtained. Patients will have the following measurements taken. 1. Baseline Maximal Inspiratory Pressure (MIP) using a handheld digital manometer, 2. 6-minute walk test (6MWT), 3. handgrip strength (HGS) of the dominant hand, and 4. 30s and 1-minute Sit-To-Stand (STS). In addition, all patients will receive the routine (20 - 40 minutes) preoperative physiotherapy education, home exercise instructions and inspiratory muscle training (if MIP < 100 cmH2O). 2. Follow up (Phone call) Patients will receive follow-up phone calls once weekly to check if they have any problems following the home exercise instructions given to them on visit 1. 3. Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again. 4. Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.
Phase
N/ASpan
30 weeksSponsor
Singapore General HospitalSingapore
Recruiting
Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international, multicenter, phase II study (Phase II) to collect more information to support the proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this study is to collect additional information to support proposed phase III dose of AAA817.
Phase
2/3Span
431 weeksSponsor
Novartis PharmaceuticalsSingapore
Recruiting
Comparison of Femto LDV Z8 Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) and Visumax Small Incision Lenticule Extraction (SMILE)
Surgical correction for refractive errors may be performed by a number of procedures. Laser correction involves refractive procedures such as laser assisted in-situ keratomileusis (LASIK), small incision lenticule extraction (SMILE), flap based refractive lenticule extraction (femtosecond lenticule extraction and pseudo-SMILE), surface ablation techniques like photorefractive keratectomy or laser epithelial keratomileusis, while lens-based corrections involve the use of phakic intra-ocular lenses. SMILE (Visumax) is a flapless refractive procedure which was introduced in 2011 for the treatment of myopia and myopic astigmatism. In this procedure a stromal lenticule is extracted through a small incision (2.0 to 5.0 mm). It involves docking, femtosecond laser application, lenticule dissection from the surrounding stroma, and extraction. Studies have suggested that using a SMILE technique resulted in better ocular surface stability and biomechanical strength when compared with LASIK. SMILE has a steep learning curve. The most common complication encountered during the initial learning curve, is difficult lenticule dissection and extraction with an incidence of up to 16%. Other intraoperative complications include suction loss, an opaque bubble layer, and tearing of the lenticule. Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) by FEMTO LDV Z8 (Ziemer) is a novel technique of flapless refractive surgery which uses low energy femtosecond laser. It creates highly focused laser pulses achieving photodisruption in the low nanojoules range (<100 nJ). Decreased stromal gas generation and accurate laser focus are the advantages of this low energy concept. The advantages of CLEAR treatment are possibility of recentering the treatment area after having performed the docking, which is not possible with the VisuMax Laser System, multiple corneal incisions for easy removal of the lenticule for the beginners, trusted vacuum with minimal suction losses. Previous study concluded that the mean preoperative sphere, cylinder, and spherical equivalents were -3.05 (D), 0.50 D, and -3.30 D respectively and 1 month after CLEAR the sphere, cylinder and spherical equivalents were 0.05 D, 0.3 D and 0.12 D respectively. As the investigators do not expect to see a great improvement to the results from the already established SMILE procedure, the investigators aim to demonstrate that CLEAR is just as good in terms of visual outcomes. However, the investigators aim to show that CLEAR has additional benefits, on top of the equal or comparative visual outcomes. Currently there are no publications comparing the refractive predictability, higher order aberrations, changes in tear neuromediators, tear proteomics, keratocytes and nerve regeneration, corneal lenticule metabolomics, intraoperative laser centration comparing CLEAR and SMILE, hence this study will be unique in the fact that the paired eye approach will act as an internal patient control to assess the objective and subjective outcomes in patients following both these procedures.
Phase
N/ASpan
148 weeksSponsor
Singapore Eye Research InstituteSingapore
Recruiting
Healthy Volunteers
Surviving the Pediatric Intensive Care Unit (PICU)
The objectives of Helping to Optimize Patients' Experiences (HOPE) after Pediatric Critical Illness Cohort Study are: 1. [Primary] To characterize physical and cognitive health outcomes of PICU survivors. 2. [Primary] To investigate subgroups of critically ill children who have poor medium-term physical and cognitive health outcomes. 3. [Primary] To elucidate risk factors for poor physical and cognitive health outcomes in PICU survivors. 4. [Exploratory] To investigate the impact of physical and cognitive health of PICU survivors on overall family health. The objectives of Singapore Health outcomes After Critical illness in Kids - Siblings (SHACK-S): Health Outcomes and Experiences of Healthy Siblings in the first 6 months after PICU discharge are: 1. [Primary] To describe and compare quality-of-life in healthy siblings at 1, 3 and 6 months after PICU discharge. 2. [Primary] To explore the experiences and support needs of healthy siblings 6 months after PICU discharge of a critically ill child. 3. [Secondary] To examine the experiences of recovery trajectory of healthy siblings. Thus, HOPE cohort will provide information and insight regarding which groups of PICU patients and associated PICU therapies are associated with the highest risk for poor survivorship. The conduct of this study will also allow us to identify the challenges and find appropriate solutions in performing a cohort study with an emphasis on patient-reported outcomes (e.g., functional status, cognition and quality of life). Concurrently, the SHACK-S cohort will provide insights to understand the impacts of PICU admission on siblings and their recovery.
Phase
N/ASpan
151 weeksSponsor
KK Women's and Children's HospitalSingapore
Recruiting
Better Risk Perception Via Patient Similarity to Control Hyperglycemia and Sustained by Telemonitoring
Diabetes has emerged as a significant public health concern globally, and Singapore is no exception. As of 2022, 8.5% of the adults in Singapore is affected by diabetes and the number is expected to reach 1 million by 2050, making it imperative to address the associated challenges. The economic implications of diabetes extend beyond healthcare costs, impacting productivity and quality of life. The total cost among the working-age population with diabetes - direct and indirect costs included - is expected to rise from USD 787 million (USD 5,646 per person) in 2010 to USD 1,867 million in 2050 (USD 7,791 per person). In addition, diabetes poses a substantial risk of complications that can adversely impact various organ systems. Complications such as cardiovascular diseases, neuropathy, and retinopathy pose severe threats to the health of individuals with poorly managed diabetes. A study on global trend of diabetes mortality revealed a concerning global increase in diabetes-related mortality, particularly due to vascular complications, posing a significant challenge to diabetes management. To address the rising trends of mortality, it is crucial to enhance awareness of diabetes complications to improve risk perception and ultimately reduce mortality rates. Perceived risk of diabetes complications can impact patient behavior, influencing adherence to treatment plans and lifestyle changes. Individuals with a higher risk perception may be more likely to engage in proactive management, leading to better health outcomes and potentially reducing mortality rates associated with diabetes complications. On the other hand, individuals with poorer risk perception may neglect necessary precautions, leading to suboptimal disease management and an increased likelihood of complications, potentially impacting mortality rates. A systematic review on risk perceptions of diabetes complications highlights a concerning lack of awareness regarding the risk of diabetes related complications among individuals with type 2 diabetes mellitus (T2DM). Similarly, research studies on diabetes complications risk awareness, particularly in Singapore, revealed knowledge gaps among adults. Despite the significant impact on quality of life, later-stage T2DM and its complications were perceived as slowly progressing and not immediately life-threatening. Hence, for poorly controlled diabetes patients, effective communication regarding the risks of complications is paramount. Weaver et al defined risk communication as "the effective and accurate exchange of information about health risks and hazards" so as to "advance risk awareness and understanding and promote health-protective behaviors". Enhancing risk communication not only promotes informed decision-making but also advances early intervention and preventive measures. Furthermore, Hashim J et al emphasized the importance of considering social and cultural factors in the development of effective interventions among adults with elevated risk perception yet do not engage in preventive actions. The study also suggested that diverse perspectives concerning the benefits and weaknesses related to preventive measures can impact the long-term sustainability of these behaviors. Risk communication interventions have been developed for patients with T2DM to improve their risk perceptions and health actions. These interventional studies explore different methods to communicate diabetes complication risks to those with T2DM. interventions include range of innovative risk communication methods like visual aids, general nudges, digital tool for personalized risk information and family support through WeChat. While such interventions contribute to valuable insights, there are some limitations with these tools like limited long-term impact, technology adoption challenges. Addressing these drawbacks with an integrated approach could enhance the robustness and applicability of the findings in diverse healthcare settings. PERDICT.AI based counselling An AI-enabled similarity-based model, named PERDICT.AI (Personalised Diabetes Counselling Tool using Artificial Intelligence) was developed by a team of primary care physicians and computer scientists in Singapore to help physicians communicate risks to patients with diabetes mellitus. The tool ranks a patients' HbA1c levels with similar patients (or peers) from a de-identified database, showing how prevalent diabetes complications are based on HbA1c severity. This is referred to as "peer-comparison" and the tool underwent revisions following feedback from primary care physicians to enhance its usefulness in risk communication. Based on Health Belief Model (HBM), a risk communication intervention, was developed for Primary care Physicians (PCPs) to counsel patients with T2DM on their glycemic control and the complications that could arise, and to recommend ways to improve glycemic control and prevent complications (or further complications). This will be supported by information from PERDICT.AI. Risk communication using PERDICT.AI dynamically communicates an individual's glycaemic control, offering a comparative ranking among peers to enhance motivation and awareness. Furthermore, it assesses the risk of potential complications comparing with peer data with exemplary cases to underscore the consequences of suboptimal management. In addition, it will generate personalized recommendations including medication adjustment and personalized health plans. Diabetes management often requires consistent encouragement and guidance, which a static risk communication tool may not deliver. In addition, passive receipt of information might not motivate patients to actively take part in diabetes management. Such lack of engagement could lead to reduced adherence to recommended strategies, limiting the tool's overall impact. This is evident from the @RISK study, where the improved risk perception observed initially at 2 weeks dissipated by the 12th week, highlighting a temporal limitation in sustaining positive outcomes. Although participants in the intervention arm reported higher satisfaction with risk communication, this did not translate into sustained improvements. This underscores the need for an integrated approach to sustain positive outcomes beyond short-term. Integration with telemonitoring system Sustaining improved risk perception over an extended period can be achieved through telemonitoring. By utilizing telemonitoring technology, healthcare providers can maintain a consistent connection with patients, offering real-time insights into their health status. Additionally, telemonitoring facilitates continuous education and support, thereby contributing to the long-term sustainability of improved risk perception and can significantly enhance diabetes management and prevent complications. The Primary Tech-Enhanced Care (PTEC) programme focuses on encouraging patients to manage chronic conditions at home through user-friendly kits. The Home Diabetes Monitoring programme (PTEC-DM) enables home-based glucose and blood pressure monitoring once a week using a Bluetooth enabled device. These reading will be securely transmitted to the study team via the app and managed appropriately through teleconsultation. Additionally, participants will receive health nudges, encouragements, and reminders through in-app messages to support their well-being. The integration of PTEC-DM with the risk communication using PERDICT.AI capitalizes on the strengths of human interaction and adaptability, contributing to a more holistic and patient-centred diabetes management approach. Such combined approach addresses both monitoring and guidance, contributing to enhanced patient understanding and informed decision-making. Hence this study is designed with the following objectives, adopting a multi-site, multi-arm randomized controlled trial design. Objectives Primary objective: i. To assess the effectiveness of the risk communication using an AI enabled tool (PERDICT.AI) in improving risk perception score, quality of life and health outcomes (medication adherence and selfcare activities and glycemic control) among poorly controlled diabetes patients ii. To determine the effectiveness of a combination of risk communication session using PERDICT.AI and telemonitoring (PTEC-DM) in improving risk perception, quality of life and health outcomes Secondary objectives: iii. To compare the impact of the two approaches in improving risk perception, quality of life and health outcomes among poorly controlled diabetes patients iv. To assess the cost-effectiveness of the advanced care by comparing the incremental costs and health outcomes v. To explore participants' views and experiences of risk communication session using PERDICT.AI, PTEC-DM and usual care vi. To explore clinician' views on utility of the new approach to improve risk perception Hypothesis: • There will be improvement in patients' risk perception score and health outcomes (glycemic control and self-care activities) after the intervention. Materials and methods Study setting The study will be conducted at 4 polyclinics from a primary care clinic cluster taking care of more than 200,000 residents with diabetes in the Eastern region of Singapore. Study design Sequential explanatory mixed-method study Quantitative: Multi-arm randomized controlled trial (RCT) at four polyclinics which includes SingHealth Polyclinics at Pasir Ris, Tampines North, Eunos and Sengkang. Qualitative: In-depth interview among the study participants' and clinician, who are integral part of the study team delivering interventions. Quantitative: Multi-arm RCT This RCT involves three arms, incorporating a combination of interventions and standard care, as outlined below. Arm 1: Advanced care with risk communication using an AI enabled tool (PERDICT.AI) + home-based monitoring using PTEC DM (main intervention arm) Arm 2: Usual care + risk communication using an AI enabled tool (PERDICT.AI) Arm 3: Usual care All groups will also receive a diabetes pamphlet. Randomization Patient participants from each study site will be randomly allocated in a 1:1:1 ratio to one of the above-mentioned arms in an open-label fashion, using computer-generated random numbers for simple randomization of subjects. The nature of the intervention makes impossible to blind patients and research team to participant allocation. The randomization sequence is written and kept in an opaque sealed envelope, which will be labelled with a serial number. The study team will open the sealed envelope once the patient has consented to participate and then will be assigned to the study arms accordingly. All participants will receive a diabetes pamphlet ('Pamphlet - Taking Control of Diabetes').
Phase
N/ASpan
64 weeksSponsor
SingHealth PolyclinicsSingapore
Recruiting
SCAD : a Registry of Spontaneous Coronary Artery Dissection
Observational, multicentre, international retrospective and prospective cohort study. Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled. Patient data will be collected at the following time-points: - First SCAD event visit (retrospectively on chart review) - First follow-up: at time of enrolment - Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion Approximately 30 countries and 120 sites will participate in this registry.
Phase
N/ASpan
353 weeksSponsor
European Society of CardiologySingapore
Recruiting
Aspirational Rehabilitation Coaching for Holistic Health (ARCH): A Pilot Pre-Post Experimental Study
Objective: The current study utilizes the empirical foundations of psychosocial recovery in first-time stroke dyads to pilot test the Aspirational Rehabilitation Coaching for holistic Health (ARCH) programme. The core objectives of this study is to 1) critically assess the pre-post effects in participants' psycho-socio-emotional and spiritual wellbeing and 2) qualitatively evaluate the feasibility and acceptability of the intervention in addressing post-stroke psychosocial challenges. Methods: For this pilot study a total of 30 survivor-caregiver dyads (N=60; 30 survivors, 30 caregivers) will be recruited directly through referrals from the collaborating hospital. The proposed sample size reflects the approximate or working number of qualitative interviews at which one could expect to be reach theoretical saturation (Morse, 2000). Participants above the ages of 21 years, recovering from their first stroke at mild to moderate degree of severity, discharged from inpatient care at no later than 3 months, clinically assessed to have cognitive capacities to engage in and complete the research study, with language capabilities in English or Mandarin and one identified primary family caregiver over the age of 21 will be recruited for this study. Consenting family dyads will undergo a 4-week dyadic intervention that integrates psychoeducation, psychosocial support, and self-compassion practices. The rationale for the intervention components was based on an in-depth analysis of the psychosocial needs and challenges of stroke survivors and family caregivers reported in the international literature, and the lived experiences of post-stroke loss, coping strategies and recovery needs of Singaporean first-time stroke survivors and family caregivers. Quantitative measurements will be taken at baseline [time point 1 (T1)], immediately after the intervention [T2], 3 months [T3] and 6 months [T4] post-intervention. The qualitative assessment of feasibility and acceptability will be conducted at post intervention [T2]. Significance: The absence of tailored, family-centered support in current stroke rehabilitation practices suggest that more and more individuals are left to their own devices in navigating this psychologically, socially, and emotionally devastating health event. Dyads participating in this study will experience, for the first time ever, a rehabilitative programme that is solely focused in providing them the comfort and support in managing their unique psycho-socio-emotional and spiritual challenges post-stroke. Results from this study hope to inform the large stroke community and eventually find advocate for the ARCH intervention to become a part of standard clinical care.
Phase
N/ASpan
131 weeksSponsor
Nanyang Technological UniversitySingapore
Recruiting
Healthy Volunteers
Intramuscular ACM-CpG Monotherapy in Patients With Advanced/Metastatic Solid Tumors With Prior Response to Immunotherapy Alone or in Combination With Chemotherapy
This is a phase 1, open-label, dose escalation and expansion study of intramuscular ACM-CpG monotherapy in patients with advanced or metastatic solid tumours. Dose escalation will be conducted and the RP2D will be determined for ACM-CpG monotherapy for intramuscular routes of administration. The study will enroll patients who have received prior immunotherapy as standard of care treatment and have had demonstrable radiological responses. Dose escalation for ACM-CpG monotherapy administered via intramuscular injection will similarly be conducted using traditional 3+3 dose escalation. Three dose levels have been planned. If the patient experiences a DLT or two Grade ≥ 2 drug-related toxicity, the dose level will be expanded according to a 3+3 design. The safety and tolerability of each dose level will be assessed by the study team after all patients enrolled in the dose level have been followed for at least 21 days after the first dose of the ACM-CpG (DLT observation period). Once the MTD is reached, the RP2D will be determined. The RP2D will be defined based on the observation of MTD in a dose level cohort, to include dose levels below the MTD, or intermediate between the pre-specified dose levels based on an overall assessment of all safety data, as well as all available PK and pharmacodynamic data, and documented objective response observations. RP2D will be a pharmacologically active dose, declared based on an aggregate of multiple factors including PK data evaluating the safety margin based on CpG7909 plasma concentrations across a range of dosing levels compared to prior data (https://pubmed.ncbi.nlm.nih.gov/17696823/) and clinical results. Dose escalation and expansion will be performed in patients that have previously responded to immune checkpoint therapy alone or in combination with chemotherapy and who have already received standard of care treatment. Following the determination of the RP2D, dose expansion will be performed. Approximately up to 30 to 40 patients will be enrolled on study.
Phase
1Span
103 weeksSponsor
National Cancer Centre, SingaporeSingapore
Recruiting
Exploring the Role of Parental Emotion Regulation and Outcomes of Parental Emotional Coaching on Child and Adolescent Psychosocial Outcomes
Proposed Methodology This research proposes 2 studies to investigate the above stated questions. Study 1 will utilize a cross-sectional design with children and adolescents, as well as their parents (from general population), completing questionnaires provided, while Study 2 will involve inviting participants from Study 1 to participate in a randomized controlled trial. Participants may choose to only participate in Study 1 and not Study 2. If participants are keen and provide consent to participate in Study 2, they will have to complete both interventions and all questionnaires required at all timepoints. Participants & Procedure Participants include children and adolescents aged 7 to 17 years old, and one of their parents. Participants will be recruited from the community and the Student Health Centre at Health Promotion Board (HPB). HPB is only used as a referral site and recruitment site. Research procedures are not conducted on their premise. Both parents and children will be required to be fluent in the English language, and all parent-child dyads will be invited to participate. In terms of procedure, interested participants (parent-child dyads) will be invited to participate. Consent will be collected from the child and their parents. For Study 1, after consent is taken, participants will be asked to complete a set of questionnaires and indicate their interest to participate in Study 2. Survey questionnaires will be administered either face-to-face or online - for face-to-face administration, the researcher will provide parent-child dyad with a tablet to complete the questionnaires; for online administration, parent-child dyads will be emailed a link to the questionnaires to complete (most likely on Qualtrics). All participants are advised to complete all questions and do not skip. A copy of the questionnaire will be shown in its entirety to participants before providing consent. For children, if they have difficulty understanding the questions, they are allowed to skip it or seek help from their parents/researcher. The parents' questionnaire should take at most 30 minutes to complete, while the child's questionnaire will take at most 15 minutes to complete. If participants only participate in Study 1, they will only be required to complete the set of questionnaires at Timepoint 1. Participants in Study 1 will not be debriefed, but they can request to be debriefed by contacting the research team and we can arrange a debrief via Zoom. In Study 2, a randomized controlled trial is designed to test the effects of parent emotion coaching on parental factors (such as ER skills, sense of competency, and mood and stress levels), child factors (such as ER skills, internalizing and externalizing problems, and treatment outcomes), as well as parent-child relationship. Participants will be a subset of Study 1's participants. If participants indicate interest to participate in Study 2, the parents will be randomly assigned to the following experimental groups: 1. Emotion Coaching Training, or 2. Waitlist Control condition. Parents in the emotion coaching workshop will be invited to attend an online training on emotion coaching strategies, while parents in the control condition will not be receiving any training workshops during the study. They will be invited to join the online workshops when the study is completed. Participants will not be informed of the group that they are assigned to, and a debrief session will be provided once they complete the study. \ The training module consists of a three-hour workshop, followed by 2 bi-weekly 30-minute phone/online consultations (participants can choose from preferred timeslot on weekdays during regular work hours). Parents and children will be required to complete the set of outcome measures at pre-, post-treatment and at a 1-month follow-up. All procedures are conducted in English only. Estimated timeline for the different groups: Treatment Group - Week 0: Questionnaire (parent and child), Weeks 1 - 5: Parent Workshop, 2 phone consults, Week 6: post-questionnaire (parent and child), Week 9 - 10: follow-up questionnaire (parent and child). Intervention phase itself will last at most 5 weeks. The 3-hour online workshop will be conducted in real-time over Zoom, by a clinical psychologist or a Masters in Clinical Psychologist student (supervised by a clinical psychologist). Waitlist Group - Week 0: Questionnaire (parent and child), Week 6: Questionnaire T2 (parent and child), Week 9-10: Questionnaire T3 (parent and child). After they have completed all 3 sets of questionnaires, they will be invited to sign up for the workshop on dates that are convenient for them. The 3-hour online workshop will be conducted in real-time over Zoom, by a clinical psychologist or a Masters in Clinical Psychologist student (supervised by a clinical psychologist). At the end of Study 2, all participants will be provided with the debrief sheet (either hard or soft copy can be provided) and offered a debrief session over Zoom. The debrief session will be conducted by the research team. In cases whereby participants may wish to have longer consultation sessions, or to extend the intervention outside of the research, they may be referred to the relevant professionals/services. Participants have until 1 week after they completed the study to decide if they wish to withdraw their research data.
Phase
N/ASpan
105 weeksSponsor
National University of SingaporeSingapore
Recruiting
Healthy Volunteers
A Study to Collect Data to Build Artificial Intelligence Derived Algorithms for Estimating Iron Status of Children
This is an exploratory, observational, pilot study that aims to build and measure the accuracy of an algorithm that estimates a child's iron status using images and/or videos, against gold standard venous blood sampling. Images and/or videos will be collected by healthcare professionals, together with blood test results. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.
Phase
N/ASpan
24 weeksSponsor
Danone Asia Pacific Holdings Pte, Ltd.Singapore
Recruiting
Healthy Volunteers