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)
Bibliographic record
Abstract
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 Ministry of Education and Research Germany (contract number: 13FH019SX8). In total, 187 participants were recruited at the beginning of August 2021. Further, 92 were excluded and 94 were randomized. Data collection will be conducted until the end of 2022. CONCLUSIONS: Our study will provide data with regard to the effectiveness of community nurse-led interventions that focus on the treatment of vulnerable adults with chronic health conditions in a community health center. In secondary analyses, the associations among influencing social factors (education, income, and employment) will be examined. We expect results that will help reduce the research-to-practice gap. TRIAL REGISTRATION: German Clinical Trials Register DRKS00026164; https://tinyurl.com/yckxc5ut. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37965.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.058 | 0.049 |
| Meta-epidemiology (narrow) | 0.008 | 0.004 |
| Meta-epidemiology (broad) | 0.014 | 0.007 |
| Bibliometrics | 0.005 | 0.004 |
| Science and technology studies | 0.005 | 0.005 |
| Scholarly communication | 0.005 | 0.005 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.011 | 0.010 |
| Insufficient payload (model declined to judge) | 0.065 | 0.014 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".