Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 14, 2022
Date Accepted: Jul 30, 2022
A care-concept of community health nursing interventions for adults with chronic health conditions in an urban area: a study protocol of a randomized controlled field trial (CoSta study)
ABSTRACT
Background:
Implementing community health nursing programmes is a new field of application in primary health sector in Germany. Hence, there is limited evidence of effective community-based and nurse-led interventions with regard to the German healthcare system. International research find-ings are mostly not transferable. The CoSta-project is the first study which examines a community health nurse-led intervention for adults with chronic health conditions.
Objective:
This study protocol describes the design and method of a randomized controlled trial in field which investigates if a community health nurse-based intervention has an impact on health-related quality of life in adults with chronic conditions.
Methods:
The study is designed as a randomized controlled trial under real-life conditions in field. In a four-month period, patients will be enrolled with at least one chronic ICD-10 diagnosis. Participants will be randomly allocated to an intervention or a control group. The maximum number of cases will be 130. The control group will be treated as usual. The intervention group will receive additionally to the treatment as usual preventive home visits, consultation and educative training offered by two community health nurses for up to 12 months.
Results:
Both groups will be followed up at baseline, after 6 and after 12 months. The primary outcome measure is the Mental Component Summary (MCS) score from the SF-36 questionnaire after 12-months. Secondary patient outcomes will be included. Ethical approval has been obtained. In secondary analyses the association of social factors influencing (education, income, employment) will be examined.
Conclusions:
This study will provide data with regard to the effectiveness of community nurse-led interven-tions which focus on the treatment of vulnerable adults with chronic health conditions in the community health centre. We expect results which will help to reduce the research-to-practice gap. Clinical Trial: The study has been registered at German Clinical Trials Register, ID: DRKS00026164 on Septem-ber 10th, 2021. Funding: The CoSta project is funded by the Federal Ministery of Education and Research, con-tract number 13FH019SX8. We acknowledge support for the article processing charge by the Open Access Publication Fund of Hamburg University of Applied Sciences.
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