Objective: The purpose of the study is to investigate the effect of two nutritional follow-up intervention methods: home visit and telephone follow-up, on ADL, physical function, quality of life, readmission, and mortality, and compare the interventions with no followup. This article describes the considerations behind the study design. Design: The study is a randomized clinical study. The randomization allocated participants to one of three groups: ‘home visit’, ‘telephone consultation’, or ‘control’. Setting: Participants were recruited from two geriatric wards between May 2011 and October 2013. The follow-up period fell eight weeks after discharge from hospital. Participants: Inclusion: Malnourished or at risk of malnutrition, 75+ years and older, home-dwelling, and living alone. Exclusion: Terminal illness, cognitive impairment, and nursing home resident. Intervention: Nutritional counselling after hospital discharge, based on individual nutritional needs identified during admission, and tailored to the individual’s preferences and situation. The intervention was performed by a clinical dietician, and included the patient’s daily home carer. The intervention took place 1 week, 2 weeks, and 4 weeks after discharge, either as face-to-face counselling in the patients’ homes (home visit group), or via telephone (telephone consultation group). The control group received no followup after discharge. Measurements: Primary outcome is a change in ADL (Barthel-100), while secondary outcomes include other physical measurements (handgrip strength, 30-sec. chair stand test, CAS), quality of life and depression measurements (SF-36, Depression List, Geriatric Depression Score), and Avlund mobility-tiredness score. Other secondary outcome measures are readmission, and mortality rates at 30 and 90 days post-discharge. Conclusion: This randomized clinical trial will evaluate and compare two approaches to nutritional follow-up after discharge from hospital with no follow-up. It is expected that these interventions will prevent deterioration in physical function, which is significant in preventing further deterioration of physical, mental, and social functions, and reduce hospital readmissions and mortality.
A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients — A twelve month follow-up
