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Background: A redistribution of tasks between specialized nurses and primary care physicians, i.e., models of advanced nursing practice, has the potential to improve the treatment and care of the growing number of people with dementia (PwD). Especially in rural areas with limited access to primary care physicians and specialists, these models might improve PwD's quality of life and well-being. However, such care models are not available in Germany in regular healthcare. This study examines the acceptance, safety, efficacy, and health economic efficiency of an advanced nursing practice model for PwD in the primary care setting in Germany., Methods: InDePendent is a two-arm, multi-center, cluster-randomized controlled intervention study. Inclusion criteria are age ≥70 years, cognitively impaired (DemTect ≤8) or formally diagnosed with dementia, and living in the own home. Patients will be recruited by general practitioners or specialists. Randomization is carried out at the physicians' level in a ratio of 1:2 (intervention vs. waiting-control group). After study inclusion, all participants will receive a baseline assessment and a follow-up assessment after 6 months. Patients of the intervention group will receive advanced dementia care management for 6 months, carried out by specialized nurses, who will conduct certain tasks, usually carried out by primary care physicians. This includes a standardized assessment of the patients' unmet needs, the generation and implementation of an individualized care plan to address the patients' needs in close coordination with the GP. PwD in the waiting-control group will receive routine care for 6 months and subsequently become part of the intervention group. The primary outcome is the number of unmet needs after 6 months measured by the Camberwell Assessment of Need for the Elderly (CANE). The primary analysis after 6 months is carried out using multilevel models and will be based on the intention-to-treat principle. Secondary outcomes are quality of life, caregiver burden, acceptance, and cost-effectiveness. In total, n=465 participants are needed to assess significant differences in the number of unmet needs between the intervention and control groups., Discussion: The study will provide evidence about the acceptance, efficacy, and cost-effectiveness of an innovative interprofessional concept based on advanced nursing care. Results will contribute to the implementation of such models in the German healthcare system. The goal is to improve the current treatment and care situation for PwD and their caregivers and to expand nursing roles., Trial Registration: ClinicalTrials.gov NCT04741932 . Registered on 2 February 2021., (© 2022. The Author(s).)

Background: Lack of physical activity (PA) and a high level of physical inactivity (PI) are associated with a higher risk for mortality and responsible for several non-communicable diseases including cardiovascular disease. Higher age is associated with a decrease of PA and an increasing level of PI. Studies have shown that interventions in the elderly have the potential to increase the amount of PA and to decrease the level of PI. However, most interventions are complex, elaborated, time- and resource-consuming. Here, we examined the effect of individual feedback-letters reporting the measured PA and PI in a sample of elderly people in Germany. Primary outcomes of the study were overall PA and PI after 6 months in the intervention group compared to a control group., Methods: We examined data from the MOVING intervention study (RCT) for people aged ≥ 65 years living in the northeast of Germany. At baseline, 3 and 6-months follow-up, all study participants wore a 3-axis accelerometer over a period of seven consecutive days. After the baseline measurement, the participants were randomized into intervention and control group. Participants in the intervention group received automatically generated, individualized feedback letters reporting their PA and PI by mail after the baseline measurement and after the 3-months follow-up. A Two-Way Mixed ANOVA with repeated measures was calculated with light, moderate and overall PA as well as PI as dependent variables, and group (between subject) and time (inner subject) as factors. The analysis based on retrospective data from the MOVING study (2016-2018)., Results: N = 258 patients were recruited. N = 166 participants could be included in the analysis, thereof N = 97 women (58.4%). The mean age was 70.8 years (SD 4.8). At baseline, the participants had a mean wearing time of 5,934.5 minutes (SD = 789.5) per week, which corresponds to about 14 hours daily on average. The overall PA in the intervention group at the 6-months follow up was 2488.8 (95% CI 2358.9-2618.2) minutes and 2408.2 (95% CI 2263.0-2553.4) minutes in the control group. There was no statistically significant interaction effect (time*group) between the intervention and control group for the depending variables. Sensitivity analyses showed significant small positive effects of the interaction time*partnership, F(2, 300) = 3.020, p = 0.05, partial η2 = 0.020., Discussion: On average, study participants had high levels of PA at baseline and showed a good adherence in wearing the accelerometer. Both is likely due to selection in the convenience study sample. Thus, some ceiling effect reduced the overall intervention effect somewhat. At baseline, the weekly average of PI was 3436.7 minutes, which correspondents to about 8.2 hours per day and about 57% of participants' daily waking time. The average level of PI could be slightly decreased in both study groups., Trial Registration Number: DRKS00010410, 17 May 2017., Competing Interests: The authors have declared that no competing interests exist.

Background: Low levels of physical activity (PA) and high levels of physical inactivity (PI) are associated with higher mortality and cardiovascular diseases. Higher age is associated with a decrease of PA, only 2.4-29% of ≥60 year-olds achieve the PA times recommended by WHO. The aim of this study was to identify levels of and determinants for moderate PA, overall PA and PI in a sample of individuals aged ≥65 years., Methods: We analyzed baseline data from an intervention-study aiming to increase PA and decrease PI by automatically generated feedback letters to objectively measured PA and PI. Recruitment was multimodal including re-contacting participants of previous studies and advertisements in regional public buses and newspapers. At baseline, participants wore an accelerometer over a period of 7 consecutive days. PA was categorized using cut-points suggested by Freedsoon 1998 in light, moderate and vigorous physical intensity as well as physical inactivity. Potential determinants (self-efficacy, education) were measured by questionnaires or in a physical examination (BMI). Multiple linear regression models were fitted to identify determinants for PA and PI., Results: N = 199 persons (mean age 71.0 years (SD 4.9), 59.3% female) participated in the study. The weekly amount of overall PA for men was on average 1,821 minutes (SD 479.1), for women on average 1,929 minutes (SD 448.8). 79.7% of the women and 72.8% of the men achieved the WHO recommendation of 30 minutes moderate PA/day at baseline. The time of PI during the observation time period of 7 days was on average 4,057 minutes in men and 3,973 minutes in women. In males, age was found to be a significant negative determinant for overall PA (p = 0.002) and for moderate PA (p<0.001). Higher education was positively associated with higher levels of overall PA (p = 0.013) and moderate PA (p = 0.06) in men. BMI was a significant negative determinant for overall PA both in men (p = 0.039) and women (p = 0.032) as well as for moderate PA for women (p = 0.009). Only in women, not in men, self-efficacy was to be a significant positive determinant for overall PA (p = 0.020) as well as negatively associated with PI (p = 0.006)., Discussion: The participants of our study showed high levels of PA. This is likely due to selection bias in this convenience sample. However, also levels of PI are very high and those correspond with average levels in the German population. The determinants for higher PA and lower PI differed between males and females. Thus, strategies for improving PA and decrease PI are likely different with respect to sex and should take individual factors (e.g. age, BMI) into account., Trial Registration Number: DRKS00010410 Date: 17 May 2017., Competing Interests: The authors have declared that no competing interests exist.

Background: Cardiovascular diseases (CVD) are the leading cause of mortality. In 2014, they were responsible for 38.9% of all causes of death in Germany. One major risk factor for CVD is a lack of physical activity (PA). A health-promoting lifestyle including regular PA and minimizing sitting time (ST) in daily life is a central preventive measure. Previous studies have shown that PA decreases in older age; 2.4-29% of the people aged over 60 years achieve the World Health Organization recommendations. This age group spends on average 9.4 h per day in sedentary activities. To increase PA and decrease ST, a low-threshold intervention, consisting of individualized feedback letters based on objectively measured data of PA and ST, was developed. The research question is: Do individual feedback letters, based on accelerometer data, have a positive effect on PA and ST?, Methods/design: MOVING is a two-arm, randomized controlled trial. Inclusion criteria are age ≥ 65 years and the ability to be physically active. Exclusion criteria are the permanent use of a wheelchair and simultaneous participation in another study on PA. At baseline participants who give informed consent will receive general information and recommendations about the positive effects of regular PA and less ST. Participants of both groups will receive an accelerometer device, which records PA and ST over a period of seven consecutive days following by a randomization. Participants in the intervention group will receive automatically generated, individualized feedback letters by mail based on their PA and ST at baseline and at 3-month follow-up. Further follow-up examinations will be carried out at 6 and 12 months. The primary outcome is the increase of PA and the reduction of ST after 6 months in the intervention group compared to the control group., Discussion: The goal of the study is to examine the effects of a simple feedback intervention on PA and ST in elderly people. We aim to achieve an effect of 20% increase in moderate-to-vigorous physical activity (MVPA). The intervention may have the potential to decrease crucial cardiovascular risk factors and, therefore, contribute to prevention of CVD., Trial Registration: German Clinical Trials Register, ID: DRKS00010410 . Registered on 17 May 2017.