Implementation of dementia care management in routine care (RoutineDeCM): a study protocol for process evaluation.

INTRODUCTION: Dementia care management is a complex intervention intended to support persons with dementia and their (caring) relatives in home-based care arrangements. Dementia care management was developed in the federal state of Mecklenburg-Western Pomerania in Germany and subsequently adapted for the German region of Siegen-Wittgenstein, where it will now be implemented. Four different service providers will carry out the implementation process. This study protocol describes the planned procedures for the parallel evaluation of the implementation process. METHODS AND ANALYSIS: A multiple embedded case study design was chosen for the planned process evaluation. Data collection and analysis will be informed by the Consolidated Framework for Implementation Research, the Expert Recommendations for Implementing Change, the Medical Research Council framework for conducting process evaluations of complex interventions and the Taxonomy of Outcomes for Implementation Research. Information (qualitative and quantitative) will be collected from all stakeholders involved in the dementia care management intervention (ie, dementia care managers, general practitioners, people with dementia). ETHICS AND DISSEMINATION: The process evaluation is conducted in accordance with the Declaration of Helsinki, the recommendations on good scientific practice, the research ethics principles of the Code of Ethics of the German Society of Nursing Science, and on the basis of ethical approval from the Clinical Ethics Committee of University Medicine Greifswald (BB 110/22). The results of the process evaluation will be disseminated through reports to the funders of the study and also as a summary of recommendations for the sustainable implementation of dementia care management for future implementers. We also plan to publish the results of this process evaluation in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05529277, Registered 7 September 2022, https://beta. CLINICALTRIALS: gov/study/NCT05529277.

[Preferences for everyday living written in the nursing record - An explorative document analysis in various nursing settings]. / Präferenzen des alltäglichen Lebens in der Pflegedokumentation.

Preferences for everyday living written in the nursing record - An explorative document analysis in various nursing settings Abstract. Background: In Germany, there was previously no instrument for the systematic recording of preferences for the everyday living of older and people in need of care. Subsequently, in a pilot study, an instrument was translated in a culturally sensitive way (PELI-D), piloted and tested psychometrically. In terms of documentation quality, it is important that the preferences recorded by nursing staff are written down in the nursing record using PELI-D, plausibly based on the nursing process. AIM: To find out which preferences, assessed by the nursing staff in the pilot study with the PELI-D, were written down in the nursing record. METHODS: An exploratory document analysis was carried out. Included were 13 nursing records and five discussion participants from five institutions in three nursing settings. The data were evaluated descriptively and by a structuring content analysis. RESULTS: A total of 2% of the preferences, which were assessed with the PELI-D, were found in the nursing records and may be due to the use of PELI-D. Preferences mainly from the categories "interventions" and "biography" were found in the nursing record. CONCLUSIONS: 98% of the preferences assessed with the PELI-D were not written down. This can probably be attributed to the fact that the PELI-D was an "innovation" for the nursing staff. Therefore, the execution of an implementation study seems to be reasonable to improve the plausibility of the captured PELI-D data in the nursing documentation. In the context of this, it is also recommended to analyze how the PELI-D influences nursing processes and contents of the nursing record.

TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone.

BACKGROUND: Caring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home. METHODS: This study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12). RESULTS: Thirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention. CONCLUSIONS: The Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial. TRIAL REGISTRATION: Clinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered).

Feasibility and effectiveness of a telephone-based social support intervention for informal caregivers of people with dementia: Study protocol of the TALKING TIME project.

BACKGROUND: Caring for people with dementia at home requires a significant amount of time, organization, and commitment. Therefore, informal caregivers, mainly relatives, of people with dementia often feel a high burden. Although on-site support groups are known to have positive effects on the subjective well-being (SWB) and perceived social support of informal caregivers, there are cases in which relatives have either no time or no opportunity to leave the person alone or in which there are no support groups nearby. The TALKING TIME project aims to close this supply gap by providing structured telephone-based support groups in Germany for the first time. International studies have shown benefits for informal caregivers. METHODS: The TALKING TIME study is a randomized controlled trial. The effects of the 3-month TALKING TIME intervention will be compared with those of a control group without intervention at two time points (baseline = T0, after 3 months = T1). The control group will receive the TALKING TIME intervention after T1. With a planned sample size of 88 participants, the study is powered to detect an estimated effect size of 0.70 for psychological quality of life, considering an α of 0.05 (two-sided), a power of 80%. Caregivers are informal caregivers who are eligible if they are 18 years of age or older and have cared for a person with diagnosed dementia for at least four hours, four days per week, in the past six months. The exclusion criteria are psychiatric disorders of the informal caregiver. The primary outcome is the mental component summary of the SF-12 rated by informal caregivers. The secondary outcomes for informal caregivers are the physical component summary of the SF-12, the Perceived Social Support Caregiver Scale (SSCS) score, and the Caregiver Reaction Scale (CRS) score. The secondary outcome for care recipients is the Neuropsychiatric Inventory (NPI-Q). For the process evaluation, different quantitative and qualitative data sources will be collected to address reach, fidelity, dosage and context. DISCUSSION: The results will provide further information on the effectiveness and optimization of telephone-based support groups for informal caregivers of people with dementia, which can help guide the further development of effective telephone-based social support group interventions. TRIAL REGISTRATION: Clinical Trials: NCT02806583 , June 9, 2016.

Risk for high depressive symptoms in diagnosed and previously undetected diabetes: 5-year follow-up results of the Heinz Nixdorf Recall study.

OBJECTIVE: The objective of this study was to determine the risk for the development of high depressive symptoms in study participants with diagnosed and previously undetected diabetes mellitus compared to those without diabetes in a prospective population-based cohort study in Germany. METHODS: We estimated the 5-year cumulative incidence of high depressive symptoms in participants without high depressive symptoms at baseline (n = 3,633, 51.4% men, mean age (SD) 59.1 (7.6) years, 7.0% diagnosed diabetes, 5.3% previously undetected diabetes) from the population-based Heinz Nixdorf Recall study. Diabetes was assessed by self-report, medication, and blood glucose. High depressive symptoms were assessed using CES-D. We calculated odds ratios and their corresponding 95% confidence interval, using multiple logistic regression analyses. RESULT: Cumulative 5-year incidences (95% CI) of high depressive symptoms in participants with diagnosed, undetected, and without diabetes were 7.1 (4.2-10.9), 4.1 (1.8-8.0), and 6.5 (5.6-7.4), respectively. The age-sex-adjusted OR for developing high depressive symptoms was 1.22 (0.74-2.03) in participants with diagnosed compared to those without diabetes, and 1.00 (0.59-1.68) after adjustment for BMI, physical activity, education, stroke, and myocardial infarction. The age-sex adjusted OR for developing high depressive symptoms in participants with previously undetected diabetes compared to those without diabetes was 0.72; 0.35-1.48; and fully adjusted 0.62; 0.30-1.30. CONCLUSION: We found no significant associations, maybe due to low power. However, our results are in line with a recent meta-analysis suggesting that risk of developing high depressive symptoms in patients with diagnosed diabetes may be moderately higher than in those without diabetes, and that comorbidity may explain in part this association. In participants with previously undetected diabetes, this first longitudinal study indicates that the risk is not increased or may even be decreased. These results support the hypothesis that high depressive symptoms develop due to diabetes-related burden and comorbidity and not due to hyperglycemia or hyperinsulinaemia.

[Abdominal massage as intervention for patients with paraplegia caused by spinal cord injury--a pilot study]. / Bauchmassage als Intervention bei Menschen mit Querschnittlähmung--eine Pilotstudie.

UNLABELLED: Patients with paraplegia caused by spinal cord injuries have to deal with the loss of the central nervous regulation of the bowel functions. The management of defaecation can take a lot of their daily time. To support the colon motility, different methods of abdominal massage are used in nursing practice. But a review of current international literature reveals, that there is still a lack of evidence for the effect of abdominal massage on defaecation. In order to prove this effect, a pilot study was conducted using a quasi-experimental design with time series and including seven patients with paraplegia caused by spinal cord injury. Data were collected over three weeks: one week before intervention, during the intervention week and one week after intervention. In the intervention week, the patients received a specific abdominal massage each morning before breakfast. Following outcome-criteria have been considered: frequency and duration of defaecation, amount and consistency of faeces as well as subjective perception of the massage and its effects. RESULTS: Some distinctive changes in the frequency and duration of defaecation could be registered over time. Most patients regarded the massage as a comfortable intervention that may have positive effects of the defaecation. Due to the pilot character of the study further research is necessary in order to validate these effects.