Source: isrctn

Inpatient or outpatient occupational rehabilitation – what works best for whom? Background and study aims Musculoskeletal disorders and common mental disorders are the main reasons for long-term sickness absence and disability. Many of these conditions have no or few medical explanations, and many patients are suffering from two or more disorders/ailments at the same time (co-morbidity). The main aim of occupational rehabilitation programs is to help people with such disabilities to return to work (RTW). However, knowledge regarding how well these programs work is very limited, and we know even less about which programs are best suited for which patients. Here, we want to compare the performance of two occupational rehabilitation programs in Norway, and examine if a particular type of patient will benefit more from the one or the other program. We will measure how many people return to work, how much they start and then stop work again and costs to society in general. We will also look at their state of health over time, quality of life, how well they perform when at work and their own belief in being able to RTW. Who can participate? Employed or self-employed adults aged 18-55 who are referred to occupational rehabilitation by a physician, and who live within a distance of 200 km from Porsgrunn, Norway. They must have musculoskeletal disorders and/or common mental health disorders, such as stress, anxiety and depression. In addition they must have been sick-listed for a minimum of six weeks last year What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 receive treatment in an outpatient occupational rehabilitation clinic at Sykehuset Telemark in Porsgrunn (STHF-intervention). Those in group 2 receive treatment in an inpatient occupational rehabilitation clinic in Rauland (AiR-intervention). The treatments (interventions) at both clinics are comprehensive and delivered by interdisciplinary teams consisting of a physician, physiotherapist, psychologist or a specialized nurse and an occupational counselor/work consultant. The inpatient intervention has in addition a physical education teacher, a nutrition counselor, a riding instructor and a recreation instructor. The inpatient intervention runs for 4 weeks and for about 35 hours/week, while the outpatient intervention has a duration of about 3 months, with the number of days and hours per week varies according to the need of the participant. Both clinics use cognitive, behavioral and educational approaches to increase the participants’ self-efficacy (belief in themselves), improve their health and quality of life, reduce fear of movement and increase their ability and readiness for returning to work. Interaction with relevant stakeholders is part of the rehabilitation process (e.g. employer, general practitioner, family and NAV). The inpatient intervention is more group-based and intensive than the outpatient intervention. The outpatient intervention on the other hand, is individually tailored, has closer collaboration with the workplace, and collaborates with local services to offer physical exercise or cognitive therapy if needed. What are the possible benefits and risks of participating? By participating in the study, the participants will get a comprehensive occupational rehabilitation service in the specialist health care whether they get the inpatient or outpatient intervention. We are not able to tell whether they would benefit more from the one or the other intervention. There are no risks involved in participating in the study. Where is the study run from? AiR - the National Centre for Occupational Rehabilitation (Norway) When is study starting and how long is it expected to run for? April 2014 to December 2024 Who is funding the study? 1. AiR - the National Centre for Occupational Rehabilitation (Norway) 2. The South- East Regional Health Authority (Helse Sør-Øst RHF) (Norway) 3. Kommunal Landspensjonskasse (KLP) (Norway) Who is the main contact? 1. Chris Jensen [email protected] 2. Monica Eftedal [email protected]

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Role of Probiotics in recovery of children with Severe Acute Malnutrition Background and study aims About 35% of global child deaths below five years of age are estimated to be caused by Undernutrition, and pneumonia and diarrhea are the two most common causes of death in undernourished children. Adding probiotics to the food of severely malnourished children may be a way to reduce the occurrence and severity of both diarrhea and airway infections in undernourished children. Studies suggest that probiotics are able to reduce the occurrence and duration of diarrhea and may reduce the risk of airway infections. Some of the probiotic studies have included mildly to moderately malnourished children, but most studies have been conducted in well-nourished populations.The main aim of the study is to measure the effect of two probiotic strains on diarrhea in children with severe acute malnutrition (SAM) when given together with the usually recommended treatment. Who can participate? Children aged 6–59 months with severe acute malnutrition. What does the study involve? Children with severe acute malnutrition admitted to a nutritional rehabilitation unit at a national referral hospital in Uganda will be recruited. All children are treated according to the WHO protocol for treatment of children with SAM. Children were randomly allocated to either receive a daily dose of probiotics or a dummy sachet of similar appearance and taste during the entire study period. The follow-up visits as an outpatient will last between 8 to 12 weeks depending on the recovery rate of the child. Each child will have body measurements performed at admission, discharge and at the follow-up visits every two weeks. Weight will be measured daily and height will be measured weekly during hospitalization. A thymus gland ultrasound scan will be carried out and blood and stool samples will be collected at admission, discharge and after 8 weeks follow-up. Diarrhea will be monitored closely with daily registration of stool frequency, stool consistency, vomiting and fever. Pneumonia is diagnosed by medical doctors.30 healthy children of the same age and from the same area will be included to collect reference samples of blood and feces and thymus scans. What are the possible benefits and risks of participating? All children will benefit from the extra attention they may get in the study especially in relation to diarrhea and pneumonia. Children that receive the probiotics may benefit from a reduced occurrence and severity of diarrhea and pneumonia. The risk associated with treatment of children with SAM with the two probiotic strains is minimal. However, as the study population is vulnerable, an independent Data Safety Monitoring Board has been established to follow safety during the study. All the procedures carried out in the study involve no or minimal risk or discomfort to the children. Where is the study run from? The study takes place at Mwanamugimu Rehabilitation Nutrition Unit, National Referral, Mulago Hospital, Department of Paediatrics and Child Health, Kampala, Uganda. When is the study starting and how long is it expected to run for? The study will take place between March 2014 and July 2015. Who is funding the study? Chr. Hansen A/S and University of Copenhagen, Denmark. Who is the main contact? Prof. Henrik Friis [email protected]

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