Pilot and feasibility studies
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Pilot Feasibility Stud · Jun 2021
Back to living well: community-based management of low back pain: a feasibility study.
Low back pain (LBP) is a long-term health condition with an unpredictable pattern of symptomatic episodes, remission, and recurrence. Recently published systematic reviews suggest that exercise is the most effective intervention for preventing recurrences of LBP in persons that have recovered. Similar programs may also be effective in preventing flare-ups in persistent LBP. The aim of this study was to test the feasibility of the Back to Living Well program (Physical activity + Education + Self-management) developed to prevent recurrence or flare-ups of LBP. The study evaluated feasibility in terms of recruitment rate, adherence, satisfaction with the exercise and education sessions, and the data collection procedures. We also aimed to evaluate barriers and facilitators to the engagement in the program. ⋯ The results show the program is feasible in terms of recruitment, low attrition, and patient satisfaction. Participants highlighted the excellent, relevant education program and the positive, personalized exercise. Future studies should evaluate the effectiveness of this intervention within a fully powered randomized controlled trial.
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Pilot Feasibility Stud · May 2021
Feasibility and acceptability of an enhanced cognitive behavioural therapy programme for parent-child dyads with anxiety disorders: a mixed-methods pilot trial protocol.
Cognitive behavioural therapy (CBT) is the most widely recognised and efficacious psychological therapy for the treatment of anxiety disorders in children and adults. However, suboptimal remission rates indicate room for improvement in treatments, particularly when both children and their parents have anxiety disorders. Bidirectional transmission and maintenance of anxiety within parent-child dyads could be better targeted by CBT, to improve treatment outcomes for children and parents with anxiety disorders. This study aimed to develop and evaluate the feasibility and acceptability of a concurrent parent-child enhanced CBT intervention that targets the individual's anxiety disorder(s), as well as the bidirectional factors that influence and maintain anxiety in the dyad. ⋯ This pilot trial will utilise a mixed-methods design to determine the feasibility and acceptability of delivering an enhanced CBT intervention for the concurrent treatment of parent-child dyads with anxiety disorders. The results of this trial will inform the development and implementation of a future definitive randomised clinical trial to evaluate intervention efficacy.
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Pilot Feasibility Stud · Mar 2021
Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial.
Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy. ⋯ The PINA study will determine feasibility and potential efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multi-centre RCT.
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Pilot Feasibility Stud · Mar 2021
Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2).
The outbreak of SARS-CoV-2 (coronavirus, COVID-19), declared a pandemic by the World Health Organization (WHO), is a global health problem with ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters often preceding an adverse event. Wearable sensors can measure vital signs continuously (e.g. heart rate, respiratory rate, temperature) remotely and can be utilised to recognise early clinical deterioration. ⋯ This trial should prove the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a global pandemic at a hotel, acting as an extension to a healthcare trust. Potential benefits would include reducing infection risk of COVID-19 to healthcare staff, with earlier recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. We hope our results can power future, robust randomised trials.
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Pilot Feasibility Stud · Feb 2021
Continuous erector spinae plane block versus intercostal nerve block in patients undergoing video-assisted thoracoscopic surgery: a pilot randomized controlled trial.
The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains controversial. Intercostal nerve blockade (ICNB) is limited by its duration of action. The erector spinae plane (ESP) block has the potential to provide satisfactory analgesia for VATS; however, the effectiveness of continuous ESP versus surgeon-performed ICNB has not been investigated. The objectives of this study were to establish feasibility of patient recruitment and follow-up before undertaking a fully powered randomized controlled trial (RCT); and, secondarily, to compare opioid usage, pain control, and sensory blockade. ⋯ A fully powered RCT is feasible with modifications. Our results also suggest that continuous ESP is safe and can decrease opioid needs. However, it is important to consider procedures to improve compliance to protocol and adherence to assigned interventions.