The effects of Digital Buddy programme on older adults ’ mental well-being: study protocol for a multi-centre, cluster randomized controlled trial
This study will employ a multi-centre, cluster-randomized, two-parallel-group, noninferiority, controlled trial design with a 1:1 group allocation ratio. In the intervention group, a Digital Buddy (i.e. a young volunteer) is assigned to a group of older adults in a 1:10 ratio. A series of training sessions for a minimum of 23 h will be provided to the older adults by Digital Buddy, who will also follow through the intervention period with the older participants. The training contents include ICT and mental health care knowledge and skills. The whole intervention period will last for 6 months between 14 sessions. In the c...
Source: Trials - February 7, 2023 Category: Research Source Type: clinical trials
The effect of vitamin D and magnesium supplementation on clinical symptoms and serum inflammatory and oxidative stress markers in patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial
This study aims to evaluate the effect of vitamin D and magnesium supplementation on clinical symptoms and serum inflammatory and oxidative stress markers in patients with COVID-19.Trial designThis study is a 4-arm randomized, double-blind, placebo-controlled clinical trial with a factorial design and the intervention period is 3 weeks.ParticipantsThis study is conducted on COVID-19 patients admitted to the Shahid Mohammadi hospital in Bandar Abbas, Iran, who are eligible for inclusion in the study. Patients are included only if they meet all of the following criteria: (1) aged from 18 to 65 years old; (2) confirmation...
Source: Trials - February 6, 2023 Category: Research Source Type: clinical trials
Efficacy of ABSOLOK ™ Clip System-RFP-2021-01 in Open Liver Resection
Condition: Bile Leak Intervention: Device: ABSOLOK™ Clip System Sponsors: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Ethicon, Inc. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 31, 2023 Category: Research Source Type: clinical trials
Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial
This study provides a simple, feasible, repeatable, and fun exercise training approach. To the best of our knowledge, there are no randomized controlled trials in the existing literature on PR-integrated coached exercise. The protocol shared in our study can be used as a reference for exercise training in patients with COPD.Trial registrationEthical approval (BF2020-236 –02) was obtained from the Guangdong Provincial Hospital of Chinese Medicine Human Research Ethics Committee. All participants signed an informed consent form. ChiCTR-2100043543. The registration date is 2021/02/21 and it is the third version. (Source: Trials)
Source: Trials - January 30, 2023 Category: Research Source Type: clinical trials
The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium
AbstractIntroductionMany adults hospitalised with COVID-19 have persistent symptoms such as fatigue, breathlessness and brain fog that limit day-to-day activities. These symptoms can last over 2 years. Whilst there is limited controlled studies on interventions that can support those with ongoing symptoms, there has been some promise in rehabilitation interventions in improving function and symptoms either using face-to-face or digital methods, but evidence remains limited and these studi es often lack a control group.Methods and analysisThis is a nested single-blind, parallel group, randomised control trial with embedde...
Source: Trials - January 26, 2023 Category: Research Source Type: clinical trials
Implementation challenges and lessons learned from the STREAM clinical trial —a survey of trial sites
ConclusionsExisting practices for clinical trial implementation should be reevaluated. Sponsors should consider the local context and the need to increase upfront investment in the cross-cutting thematic areas identified to improve trial implementation. (Source: Trials)
Source: Trials - January 23, 2023 Category: Research Source Type: clinical trials
Update to the study protocol Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoid ideations in patients with schizophrenia spectrum disorders: a randomized clinical trial
AbstractWe unfortunately need to make an update to our published study protocol that describes a significant change in the design of the study. The Committee on Health Research Ethics of the Capital Region Denmark recently rejected the approval of changing the primary outcome in the trial, on the invariable grounds that the trial has already commenced. It is therefore necessary to retain the Green Paranoid Thought Scale (GPTS) part B, ideas of persecution, as our primary outcome, and GPTS part A, ideas of social reference, as a secondary outcome, which is described opposite in our published study protocol. The exchange of ...
Source: Trials - January 23, 2023 Category: Research Source Type: clinical trials
