Contemporary clinical trials communications
-
Contemp Clin Trials Commun · Sep 2020
Enhancing vocational training in corrections: A type 1 hybrid randomized controlled trial protocol for evaluating virtual reality job interview training among returning citizens preparing for community re-entry.
The Michigan Department of Corrections operates the Vocational Villages, which are skilled trades training programs set within prisons that include an immersive educational community using virtual reality, robotics, and other technologies to develop employable trades. An enhancement to the Vocational Villages could be an evidence-based job interview training component. ⋯ The primary goal of this study is to report on the protocol we developed to evaluate the effectiveness of VR-JIT at improving interview skills, increasing job offers, and reducing recidivism when delivered within two Vocational Villages via a randomized controlled trial and process evaluation. Our aims are to: (1) evaluate whether services-as-usual in combination with VR-JIT, compared to services-as-usual alone, enhances employment outcomes and reduces recidivism among returning citizens enrolled in the Vocational Villages; (2) evaluate mechanisms of employment outcomes and explore mechanisms of recidivism; and (3) conduct a multilevel, mixed-method process evaluation of VR-JIT implementation to assess the adoptability, acceptability, scalability, feasibility, and implementation costs of VR-JIT.
-
Contemp Clin Trials Commun · Sep 2020
Safety and therapeutic effects of anti-fibrotic Traditional Chinese Medicine Fuzheng Huayu on persistent advanced stage fibrosis following 2 years entecavir treatment: Study protocol for a single arm clinical objective performance criteria trial.
Hepatitis B virus (HBV) infection is an important etiology for chronic hepatitis globally, and especially so in China. HBV infection can lead to the development of cirrhosis through the pathological process of liver fibrosis. The effective suppression of HBV replication with NAs or interferon-alpha can histologically regress the fibrotic pathological process, but there remain patients who have achieved anti-viral responses and normalization of serum liver tests, but not liver fibrosis regression. This subset of patients typically presents with advanced liver fibrosis at baseline. Therefore, it is reasonable to administer the anti-fibrotic agents, coupled with antivirals for patients with advanced liver fibrosis due to HBV, in order to improve the fibrotic regression of the patients. Fuzheng Huayu (FZHY) tablet is a botanical product with evidence demonstrating its efficacy against mild to moderate liver fibrosis. The current clinical trial evaluates the efficacy and safety of the combination therapy of traditional Chinese medicine (TCM) (FZHY and herbal granule) and entecavir for HBV compensated cirrhosis. We will enroll HBV patients who presented with a good viral response after 2 years of entecavir treatment but had advanced liver fibrosis (≥Ishak F5). ⋯ The study has been designed to test the therapeutic effects and safety of the combination therapy of FZHY and herbal granule with entecavir on persistent advanced stage fibrosis/cirrhosis following 2 years entecavir treatment, and to explore an effective integrative therapy on HBV cirrhosis.