Development of core outcome sets of Food for Special Medical Purposes designed for type 2 diabetes mellitus: a study protocol
This study uses type 2 diabetes mellitus (T2DM) as an example to develop COS for clinical trials of FSMP.MethodsThe COS for FSMP-T2DM will be divided into 3 phases and developed following COS-STAP and COS-STAD:(1) Generate a list of relevant outcomes identified from a systematic review, in which information sources will mainly include published studies, regulatory documentation, and qualitative interviews of stakeholders. The identified outcomes will be categorized using a conceptual framework and formatted into the first round of the Delphi survey questionnaire items.(2) At least 2 rounds of Delphi surveys will be perform...
Source: Trials - March 24, 2023 Category: Research Source Type: clinical trials
Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial
This study is a cluster-randomized controlled trial with two treatment arms and one control arm. The unit of randomization is a primary healthcare facility along with all RHMs (and their corresponding service areas) assigned to the facility. A total of 84 primary healthcare facilities were randomized in a 1:1:1 ratio to the three study arms. The first treatment arm implements differentiated service delivery (DSD) models at the clinic and community levels with the objective of improving treatment uptake and adherence among clients with diabetes or hypertension. In the second treatment arm, community distribution points (CDP...
Source: Trials - March 22, 2023 Category: Research Source Type: clinical trials
Reducing HIV-related stigma among young people attending school in Northern Uganda: study protocol for a participatory arts-based population health intervention and stepped-wedge cluster-randomized trial
This study, to be conducted in a post-conflict, rural setting in Omoro District, Uganda, will develop and evaluate a transformative arts-based HIV-related stigma intervention rooted in local cultural knowledge to reduce stigma and improve HIV prevention and care for young people living with HIV. The intervention will be delivered to young people attending school by community Elders, with the support of teachers, through the transfer of local cultural knowledge and practices with the aim of re-establishing the important cultural and social role of Elders within a community that has suffered the loss of intergeneration...
Source: Trials - December 23, 2022 Category: Research Source Type: clinical trials
Efficacy of the Digital Therapeutic sinCephalea in the prophylaxis of migraine in patients with episodic migraine: study protocol for a digital, randomized, open-label, standard treatment controlled trial
This study is designed to fill this gap.MethodsPatients between 18 and 65 years of age with proven migraine and a minimal disease severity of 3 migraine days per month are included. After a 4-week baseline phase as a pre-study, patients are randomized to the DTx intervention or a waiting-list control. The objective of the study is to show differences between the intervention and control groups regarding the change of migraine symptoms and of effects of migraine on daily life.DiscussionTo our knowledge, this is the first systematic clinical trial with a fully digital program to enable patients with migraine to follow a pers...
Source: Trials - December 12, 2022 Category: Research Source Type: clinical trials
