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Telephone based health coaching (TBHC) seems to be a promising approach to foster self-management in patients with chronic conditions. The aim of this study was to evaluate the effectiveness of a TBHC on patient-reported outcomes and health behavior for people living with chronic conditions in Germany. Of the 10,815 invited patients, 4,283 returned their questionnaires at baseline. The mean age was 67.23 years (SD = 9.3); 55.5% were female. According to the model, TBHC was statistically significant superior to CG regarding 6 of 19 outcomes: physical activity in hours per week (p = .030) and in metabolic rate per week (p = .048), BMI (p = .009) (although mainly at baseline), measuring blood pressure (p< .001), patient activation (p< .001), and health literacy (p< .001). Regarding stages of change (p = .005), the IG group also showed statistically different results than the CG group, however the conclusion remains inconclusive. Within-group contrasts indicating changes from baseline to follow-ups and significant between-group comparisons regarding these changes supported the findings. Standardized effect sizes were small. TBHC did not show any effect on mental QoL, health status, alcohol, smoking, adherence, measuring blood sugar, foot monitoring, anxiety, depression and distress. Campaign-specific subgroup effects were detected for 'foot monitoring by a physician' and 'blood sugar measurement'. TBHC interventions might have small effects on some patient reported and behavioral outcomes. Future research should focus on analyzing which intervention components are effective and who profits most from TBHC interventions.

The Health Literacy Questionnaire (HLQ), developed in Australia in 2012 using a 'validity-driven' approach, has been rapidly adopted and is being applied in many countries and languages. It is a multidimensional measure comprising nine distinct domains that may be used for surveys, needs assessment, evaluation and outcomes assessment as well as for informing service improvement and the development of interventions. The aim of this paper is to describe the German translation of the HLQ and to present the results of the validation of the culturally adapted version. The HLQ comprises 44 items, which were translated and culturally adapted to the German context. This study uses data collected from a sample of 1,058 persons with chronic conditions. Statistical analyses include descriptive and confirmatory factor analyses. In one-factor congeneric models, all scales demonstrated good fit after few model adjustments. In a single, highly restrictive nine-factor model (no cross-loadings, no correlated errors) replication of the original English-language version was achieved with fit indices and psychometric properties similar to the original HLQ. Reliability for all scales was excellent, with a Cronbach's Alpha of at least 0.77. High to very high correlations between some HLQ factors were observed, suggesting that higher order factors may be present. Our rigorous development and validation protocol, as well as strict adaptation processes, have generated a remarkable reproduction of the HLQ in German. The results of this validation provide evidence that the HLQ is robust and can be recommended for use in German-speaking populations. German Clinical Trial Registration (DRKS): DRKS00000584. Registered 23 March 2011.

Background Developing cancer in young adulthood is a non-normative life event and associated with adverse physical, social and psychological consequences. High psychological distress is common in AYA cancer patients including anxiety, depression or fear of recurrence. At the same time, it is well known that AYA often report unmet needs for support, particularly in terms of informational exchange and emotional support from peers in order to benefit from shared experiences and enhance self-efficacy. Especially in the AYA group, interactions with other same-aged cancer patients may represent an essential resource in terms of coping with the disease, as family members and friends are often overwhelmed and struggling with helplessness. Currently, there is a lack of professional support services using peer support (e.g. psycho-oncological support, aftercare consultations, social legal counselling) or evaluated peer support interventions in Germany. Our aim is to assess the effectiveness of the Peer2Me intervention for AYAs, in which acute patients (mentees) are accompanied by an AYA survivor (mentor) over a period of three months. Methods A prospective Comprehensive Cohort Design with repeated measures will be used to evaluate the effectiveness of Peer2Me for AYA. A sample of 180 patients in active cancer treatment aged 18 to 39 years will be enrolled and randomized to the intervention or control condition (a single AYA-specific consultation). Following mentor training, mentees and mentors are matched by diagnosis, age, and gender. The primary outcome is self-efficacy; secondary outcomes include measures of anxiety, depression, health literacy, life satisfaction and social support life. Outcomes will be measured at baseline before the intervention (t1), immediately after completion of the three-month intervention (t2) and three months after completion the intervention (t3). For the final analyses, we will use an intention-to-treat approach (ITT) and compare patients in the assigned treatment groups. Discussion Peer2Me might be an important addition to existing professional psychosocial support services for young cancer patients. At the end of the study, a psycho-oncological intervention for young cancer patients undergoing acute treatment should be available, from which both mentors and mentees could benefit. The long-term continuity of Peer2Me should be ensured through collaboration with different partners. Trial Registration The study was retrospectively registered on February 4, 2022 at clinicaltrials.gov (NCT05336318).

Background Numerous studies suggest that young adult cancer survivors (YA-CS) experience unmet needs regarding informational exchange about their disease and emotional support from peers. Currently, there is a lack of evaluated peer support interventions in Germany. This study aimed to evaluate the effectiveness of “Peer2Me”, a three-month one-to-one peer mentoring program, designed to improve self-efficacy among YA-CS. Methods This study conducted a bi-center comprehensive cohort design and enrolled YA-CS (18–39 years old) undergoing acute treatment in Leipzig and Hamburg (Germany) across all tumour entities diagnosed within the last six months. YA-CS were allocated by preference to the intervention (IG, receiving peer mentoring) and comparison group (CG, care as usual). Following mentor training, tandems were matched by diagnosis, age, and gender. YA-CS completed questionnaires at baseline (t1), post-intervention (3 months later, t2) and three months post-intervention (t3). The primary outcome was self-efficacy measured with the Generalized Self-Efficacy Scale (GSES) and the Cancer Behaviour Inventory (CBI-B). Statistical analyses included mixed-design ANOVA and ANCOVA, controlling for baseline scores. Results Out of 274 eligible YA-CS, a total of 106 YA-CS (IG: n  = 77, CG: n  = 29) completed the study. Two-thirds of YA-CS (66.7%) expressed a clear preference to be allocated to the IG. Baseline differences in coping behaviors were noted, with the IG demonstrating lower scores, suggesting a higher need for support. The ANCOVA revealed no group effects for the change of mean GSES scores from t1 to t2 ( p  =.897) or from t1 to t3 ( p  =.779). Also, no significant differences in the improvement of mean CBI-B scores between groups could be found from t1 to t2 ( p  =.903) or from t1 to t3 ( p  =.995). Conclusions The “Peer2Me” program did not demonstrate a significant effect on improving self-efficacy among YA-CS during acute treatment. Although interest in peer mentoring was high, the intervention showed no measurable benefit in comparison with standard care. While the need for support was evident, further research is required to optimize peer interventions for this group. Trial registration The study was retrospectively registered on February 4, 2022 at clinicaltrials.gov (NCT05336318).

Chronic diseases, like diabetes mellitus, heart disease and cancer are leading causes of death and disability. These conditions are at least partially preventable or modifiable, e.g. by enhancing patients' self-management. We aimed to examine the effectiveness of telephone-based health coaching (TBHC) in chronically ill patients. This prospective, pragmatic randomized controlled trial compares an intervention group (IG) of participants in TBHC to a control group (CG) without TBHC. Endpoints were assessed two years after enrolment. Three different groups of insurees with 1) multiple conditions (chronic campaign), 2) heart failure (heart failure campaign), or 3) chronic mental illness conditions (mental health campaign) were targeted. The telephone coaching included evidence-based information and was based on the concepts of motivational interviewing, shared decision-making, and collaborative goal setting. Patients received an average of 12.9 calls. Primary outcome was time from enrolment until hospital readmission within a two-year follow-up period. Secondary outcomes comprised the probability of hospital readmission, number of daily defined medication doses (DDD), frequency and duration of inability to work, and mortality within two years. All outcomes were collected from routine data provided by the statutory health insurance. As informed consent was obtained after randomization, propensity score matching (PSM) was used to minimize selection bias introduced by decliners. For the analysis of hospital readmission and mortality, we calculated Kaplan-Meier curves and estimated hazard ratios (HR). Probability of hospital readmission and probability of death were analysed by calculating odds ratios (OR). Quantity of health service use and inability to work were analysed by linear random effects regression models. PSM resulted in patient samples of 5,309 (IG: 2,713; CG: 2,596) in the chronic campaign, of 660 (IG: 338; CG: 322) in the heart failure campaign, and of 239 (IG: 101; KG: 138) in the mental health campaign. In none of the three campaigns, there were significant differences between IG and CG in time until hospital readmission. In the chronic campaign, the probability of hospital readmission was higher in the IG than in the CG (OR = 1.13; p = 0.045); no significant differences could be found for the other two campaigns. In the heart failure campaign, the IG showed a significantly reduced number of hospital admissions (-0.41; p = 0.012), although the corresponding reduction in the number of hospital days was not significant. In the chronic campaign, the IG showed significantly increased number of DDDs. Most striking, there were significant differences in mortality between IG and CG in the chronic campaign (OR = 0.64; p = 0.005) as well as in the heart failure campaign (OR = 0.44; p = 0.001). While TBHC seems to reduce hospitalization only in specific patient groups, it may reduce mortality in patients with chronic somatic conditions. Further research should examine intervention effects in various subgroups of patients, for example for different diagnostic groups within the chronic campaign, or duration of coaching. German Clinical Trials Register DRKS00000584.

The objectives of the study were to generate normative data for the RS-11 for different age groups for men and women and to further investigate the construct validity and factor structure in the general population. Nationally representative face-to face household surveys were conducted in Germany in 2006 (n = 5,036). Normative data for the RS-11 were generated for men and women (53.7% female) and different age levels (mean age (SD) of 48.4 (18.0) years). Men had significantly higher mean scores compared with women (60.0 [SD = 10.2] vs. 59.3 [SD = 11.0]). Results of CFA supported a one-factor model of resilience. Self-esteem (standardized β = .50) and life satisfaction (standardized β =.20) were associated with resilience. The normative data provide a framework for the interpretation and comparisons of resilience with other populations. Results demonstrate a special importance of self-esteem in the understanding of resilience.

Background Oncological patients often feel left out of important treatment decisions. However, when physicians engage them in shared decision-making (SDM), patients benefit in many ways and the situation is improved. SDM can effectively be taught to physicians, but participation barriers for SDM physician group trainings are high, making it hard to convince physicians to participate. With this in mind, we aim to develop and evaluate two new dissemination strategies for a brief, SDM training program based upon a proven SDM group-training concept: an individualized context-based SDM face-to-face training (IG I) and a web-based interactive SDM online training (IG II). We aim to analyze which improvements can be achieved by IG I and II compared to a control group (CG) in physician SDM competence and performance as well as the impact on the physician-patient relationship. Furthermore, we analyze differences in satisfaction concerning the two dissemination strategies by means of a training evaluation. Methods/design We examine – based on a three-armed randomized controlled trial (IG I, IG II, CG) – the effectiveness of two new dissemination strategies for a SDM training program compared to a CG receiving no SDM training (voluntary access to SDM training as an incentive for participation after completion of the study). We aim to include 162 physicians randomized to one of the three arms. There will be two assessment points in time (before intervention: T 0 and post-training: T 1 ). The main outcome is the SDM competence of physicians as measured by an established observational assessment rating system (OPTION-12) by means of consultations with Standardized Patients. Standardized Patients are individuals trained to act as “real” patients. Secondary outcome measures are the SDM performance (SDM-Q-9) and the Questionnaire on the Quality of Physician-Patient-Interaction (QQPPI) both rated by Standardized Patients as well as the physicians’ training evaluation. Discussion This trial will assess the effectiveness and acceptability of two new dissemination strategies for a brief, SDM training program for physicians. Opportunities and challenges regarding implementation in daily routines will be discussed. Trial registration ClinicalTrials.gov, Identifier: NCT02674360 . Prospectively registered on 4 February 2016.

Background The Patient Activation Measure (PAM) consists of 13 items and assesses patient (or consumer) self-reported knowledge, skills, and confidence for self-management of one’s health or chronic condition. The aim of this study was to translate the original American version of the PAM13 into German and to test the psychometric properties of the German version in an elderly, multimorbid population with various chronic conditions. Methods Translation was performed by a standardized forward-backward translation process. The PAM13 was sent to 9.075 participants enrolled in a randomized controlled study. 4.306 participants responded to the questionnaire. Descriptive and reliability analyses were carried out. To examine scale properties, Andrich’s Rasch Rating Scale Model was fitted. Results The internal consistency is good (α = 0.88) and the item-rest-correlations were found as strong to moderate. The unidimensionality of the construct was confirmed, with a variance explanation of 40.9% and good model-fits for the Rasch model. However, the lowest response options were very rarely used across all items (below 5%) and ranking order of items according to their difficulty was substantially different from that of the American version. Differential item functioning (DIF) was found in subgroups (sex, age, health status), but differences were small. Conclusion The German version of the PAM13 showed acceptable reliability and the model-fit statistics confirmed the Rasch model. The different ranking order of the items and the unfair distribution of the response options suggest further research on validation and revision of the construct.

Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety. The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; and 2) to develop a supportive intervention based on the prior results. A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in 400 patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed. Currently, phase 1 of the project has been completed and the recruitment for phase 2 has been started. The systematic review and meta-analysis of phase 3 are conducted simultaneously to phase 2 and results are expected soon. Phase 4 has not been started yet. The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover, the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed.

Background The rising prevalence of chronic conditions constitutes a major burden for patients and healthcare systems and is predicted to increase in the upcoming decades. Improving the self-management skills of patients is a strategy to steer against this burden. This could lead to better outcomes and lower healthcare costs. Health coaching is one method for enhancing the self-management of patients and can be delivered by phone. The effects of telephone-based health coaching are promising, but still inconclusive. Economic evaluations and studies examining the transferability of effects to different healthcare systems are still rare. Aim of this study is to evaluate telephone-based health coaching for chronically ill patients in Germany. Methods/Design The study is a prospective randomized controlled trial comparing the effects of telephone-based health coaching with usual care during a 4-year time period. Data are collected at baseline and after 12, 24 and 36 months. Patients are selected based on one of the following chronic conditions: diabetes, coronary artery disease, asthma, hypertension, heart failure, COPD, chronic depression or schizophrenia. The health coaching intervention is carried out by trained nurses employed by a German statutory health insurance. The frequency and the topics of the health coaching are manual-based but tailored to the patients’ needs and medical condition, following the concepts of motivational interviewing, shared decision-making and evidence-based-medicine. Approximately 12,000 insurants will be enrolled and randomized into intervention and control groups. Primary outcome is the time until hospital readmission within two years after enrolling in the health coaching, assessed by routine data. Secondary outcomes are patient-reported outcomes like changes in quality of life, depression and anxiety and clinical values assessed with questionnaires. Additional secondary outcomes are further economic evaluations like health service use as well as costs and hospital readmission rates. The statistical analyses includes intention-to-treat and as-treated principles. The recruitment will be completed in September 2014. Discussion This study will provide evidence regarding economic and clinical effects of telephone-delivered health coaching. Additionally, this study will show whether health coaching is an adequate option for the German healthcare system to address the growing burden of chronic diseases. Trial registration German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS) DRKS00000584 .