Methods: ONTIME is a 28-week, phase 4, randomised, double-blind, placebo-controlled, exploratory pilot study initiated at four centres across Malaysia, the Philippines, Singapore and Thailand. Subjects (n = 42) with moderate to severe ULS (modified Ashworth scale [MAS] score ≥2) in elbow flexors or pronators, wrist flexors, or finger flexors will be recruited. Subjects will be randomised 2:1 to abobotulinumtoxinA 500 U or placebo (single dose 2-12 weeks after first-ever stroke).Primary efficacy will be measured by time between initial injection and visit at which reinjection criteria (MAS score ≥2 in the primary targeted muscle group and appearance or reappearance of symptomatic ULS) are met. Follow-up visits will be 4-weekly to a maximum of 28 weeks.
Discussion: This pilot study will facilitate the design and sample size calculation of further confirmatory studies, and is expected to provide insights into the optimal management of post-stroke patients, including timing of BoNT-A therapy and follow-up duration.
Methods: Participants (9-11 years old) were recruited and randomized into 4 treatment groups (600 mg calcium, 12 g SCF, 12 g SCF plus 600 mg calcium and placebo). Interventions were consumed as a fruit-flavored powdered drink for 1-year. School-based recruitment was effective due to support on study benefits from parents and teachers, peer influence and a 2-weeks study run-in for participants to assess their readiness to commit to the study protocol. Retention strategies focused on building rapport through school-based fun activities, WhatsApp messaging, providing health screening and travel reimbursements for study measurements. Compliance was enhanced by providing direct on-site school feeding and monthly non-cash rewards. Choice of 2 flavors for the intervention drinks were provided to overcome taste fatigue. Satisfaction level on the manner in which the study was conducted was obtained from a voluntary sub-set of participants.
Results: The study successfully enrolled 243 participants within 6 months and retained 82.7% of the participants at the end of 1 year, yielding a drop-out rate of 17.3%. Compliance to the intervention drink was 85% at the start and remained at 78.7% at the end of 1 year. More than 95% of the participants provided good feedback on intervention drinks, rapport building activities, communication and overall study conduct.
Conclusion: Successful strategies focused on study benefits, rapport building, frequent communication using social media and non-cash incentives helped improved compliance and retention rate. The lessons learned to maintain a high retention and compliance rate in this study provide valuable insights for future studies in a similar population.
METHODS: From 1 May to December 31, 2023, a prospective, multicenter, parallel-design randomised controlled trial will be conducted with two groups, each consisting of 47 participants. The intervention group will receive a structured, four-session group-based program guided by experienced pharmacists, focusing on medication adherence and diabetes management. The control group will follow the standard Diabetes Mellitus Adherence Clinic program. The primary outcomes of this study encompass enhancements in knowledge regarding diabetes medication management and adherence, followed by subsequent changes in HbA1c levels.
CONCLUSIONS: The successful implementation of the PICC program holds promise for enhancing health outcomes in the T2DM population, potentially leading to more effective diabetes management initiatives and better health practices in the community.
TRIAL REGISTRATION CLINICALTRIALSGOV IDENTIFIER: NCT05106231.
METHODS: Study metrics were recorded. Learning points were captured during network development, categorized and included in a thematic analysis from which lessons learnt were identified.
RESULTS: 12 trials were supported by sites coordinated at national level and integrated at European level. A total of 9 CDA cycles were completed, resulting in 436 site CDAs signed in a median of 8.11 days. Lessons learnt included the importance of: relationship building by early engagement with partners; reducing misunderstanding by clear communication; flexibility, adaptability and experiential learning which are required for service improvement. Practical actions that infrastructure developers and users can take include operational planning with a view to fostering collaborations across stakeholders, sharing information about different approaches to clinical operations, and raising awareness of the need for explicit work on collaboration, communication, and planning. Traditionally, these activities are repeated for each trial. The use of a persistent network allows the benefits of collaboration to be recycled.
DISCUSSION: Building a successful framework for collaboration allows dedication and determination to carry over from one study to another. The initial investment of time to share assumptions and "state the obvious" by each user will support future trials.