pragmatic randomized controlled trial
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Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Markus Gerber ◽  
Flora Colledge ◽  
Dominique de Quervain ◽  
Konstantinia Filippou ◽  
Elsa Havas ◽  
...  

Abstract Background Due to ongoing political and social conflicts, the number of international refugees has been increasing. Refugees are exposed to severe mental and physical strain, as well as traumatic experiences during their flight. Therefore, the risk of psychiatric disorders is markedly increased among international refugees. International organizations have criticized the lack of early interventions as a key problem, because untreated mental disorders are often difficult to cure at a later stage. Today, exercise and sport have been successfully employed to treat a wide range of psychiatric disorders. With patients with post-traumatic stress disorders (PTSD), very limited empirical evidence exists, and studies carried out with international refugees are nearly non-existent. Methods We intend to implement a pragmatic randomized controlled trial (RCT) with an exercise and sport intervention group (n = 68, 50% women) and a wait-list control group (n = 68, 50% women) in the Koutsochero refugee camp, located close to the city of Larissa (Greece). During the RCT, exercise and sport will be offered five times per week (60 min/session) for 10 weeks. Participants will be asked to participate in at least two sessions per week. The programme is developed according to the participants’ needs and preferences and they will be able to choose between a range of activities. PTSD symptoms will serve as primary outcome, and several secondary outcomes will be assessed. Qualitative data collection methods will be used to gain a more in-depth appraisal of the participants’ perception of the intervention programme. In the second year of study, the programme will be opened to all camp residents. A strategy will be developed how the programme can be continued after the end of the funding period, and how the programme can be scaled up beyond the borders of the Koutsochero camp. Discussion By moving towards the primary prevention of chronic physical conditions and psychiatric disorders, a relevant contribution can be done to enhance the quality and quantity of life of refugee camp residents in Greece. Our findings may also strengthen the evidence for exercise as medicine as a holistic care option in refugee camps, by helping camp residents to adopt and maintain a physically active lifestyle. Trial registration The study was registered prospectively on the 8 February 2021 with ISRCTN https://www.isrctn.com/ISRCTN16291983


2021 ◽  
Vol 4 (4) ◽  
pp. 70
Author(s):  
Jennifer Boak ◽  
Irene Blackberry ◽  
Tshepo Rasekaba

Background: Community-dwelling older clients are becoming increasingly complex. Detecting this complexity in clinical practice is limited, with greater reliance on community nurses’ clinical judgment and skills. The lack of a consistent approach to complexity impacts the level of care and support for older clients to remain in their homes for longer. Objective: To examine the effectiveness of the Patient Complexity Instrument (PCI) in addition to nurses’ clinical judgment to enhance detection of complexity, and subsequent older clients’ resource allocation compared to usual nursing assessment. Design: A pragmatic randomized controlled trial will be conducted within a community nursing service in regional Victoria, Australia. Clients 65 years and over referred to the service who are eligible for Commonwealth Home Support Programme (CHSP) funding will be randomized into Control group: usual nursing assessment or Intervention group: usual nursing assessment plus the PCI. Nurse participants are Registered Nurses currently employed in the community nursing service. Results: This study will explore whether introducing the PCI in a community nursing service enhances detection of complexity and client care resource allocation compared to nurses’ clinical judgment based on usual nursing assessment. Conclusion: This protocol outlines the study to enhance the detection of complexity by nurses delivering care for community-dwelling older people in the regional Australian context. The findings will inform the use of a standardized tool to detect complexity among community-dwelling older Australians.


2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Jill Tinmouth ◽  
Rinku Sutradhar ◽  
Qing Li ◽  
Jigisha Patel ◽  
Nancy N. Baxter ◽  
...  

2021 ◽  
Vol 49 (9) ◽  
pp. 1-8
Author(s):  
David Pearson ◽  
Fiona Clare Kennedy ◽  
Suchetha Bhat ◽  
Vishal Talreja ◽  
Katherine Newman-Taylor

Adolescence may be a window of opportunity to attenuate the effects of early social adversity, which impedes cognitive, emotional, and social development, and increases risk of psychopathology into adulthood. We ran a pragmatic randomized controlled trial to assess the impact of a brief intervention designed to facilitate life skills for psychosocial competence. Socially disadvantaged young people living in South India who had experienced early adversity (N = 645; age range = 17–22 years) participated in the intervention or were assigned to a wait-list control group. The intervention led to large differences in life skills between the two groups. This brief, scalable intervention can be made available to address the impact of early social adversity on young people's development.


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