A care concept of community health nursing Interventions for adults with chronic health conditions in an urban area : protocol for a randomized controlled field trial (CoSta Study) ; Ein Community Health Nurse Versorgungskonzept für chronisch Kranke im städtischen Quartier: Studienprotokoll für eine randomisiert-kontrollierte Feldstudie (CoSta-Studie)

Background: Implementing community health nursing programs is a new field of application in the primary health sector of Germany. Hence, there is limited evidence of effective community-based and nurse-led interventions with regard to the German health care system. International research findings are mostly not transferable. The Community Health Nursing in der Stadt (CoSta; ie, “Community Health Nursing in the City”) project is the first study that examines a community health nurse–led intervention for adults with chronic health conditions. Objective: This study protocol describes the design and methods of a randomized controlled field trial that will investigate if a community health nurse–based intervention has an impact on health-related quality of life in adults with chronic conditions. Methods: The study was designed as a randomized controlled trial that will be conducted under real-life conditions in the field. In a 4-month period, patients with at least 1 chronic International Classification of Diseases, Tenth Revision, diagnosis will be enrolled. Participants will be randomly allocated to an intervention group or a control group. The sample size was assumed based on an effect size of 0.50 with a significance level of .05, using a 2-sided (2-tailed), 2-sample unequal variance t test. The control group will be treated as usual. The intervention group will receive—in addition to the usual treatment—preventive home visits; consultations; and educative training, which will be offered by 2 community health nurses for up to 12 months. Both groups will be followed up at baseline, after 6 months, and after 12 months. The primary outcome measure is the mental component summary score from the 36-Item Short Form Health Survey after 12-months. Secondary patient outcomes will be included. The study received ethics approval from the Competence Health Center’s institutional review board at the University of Applied Sciences Hamburg (procedure number: 2020-14). Results: The CoSta project was funded by the Federal ...