Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease.

BACKGROUND: Supervised exercise programs are used to treat intermittent claudication (IC). Home-based exercise programs have been developed to lower barriers to participation. We studied the effects of one such exercise program (TeGeCoach) on self-reported walking ability in patients with IC. METHODS: In a pragmatic multicenter randomized controlled trial (registration number NCT03496948), 1982 patients with symp - tomatic IC insured by one of three German statutory health insurance funds received either telephone health coaching with remote exercise monitoring (TeGeCoach; n = 994) or routine care (n = 988). The primary outcome was the change in Walking Impairment Questionnaire (WIQ) scores after 12 and 24 months in the intention-to-treat population. The secondary outcomes were healthrelated quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine depen - dence. RESULTS: There was a significant group difference in WIQ score in favor of TeGeCoach (p < 0.0001), amounting to 6.30 points at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen's d = 0.26) and 4.55 points at 24 months ([2.20; 6.91], d = 0.19). Some of the secondary outcomes also showed positive results in favor of TeGeCoach at 12 months with small effect sizes (d ≥ 0.20), including physical health-related quality of life and patient activation. The average daily step count was not higher in the TeGeCoach group. CONCLUSION: Significant improvements regarding symptom burden demonstrate the benefit of a home-based exercise program and thus expand the opportunities for guideline-oriented treatment of IC. Future studies should additionally address the effect of home-based exercise programs on clinical variables by means of, for example, the 6-minute walk test.

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial.

BACKGROUND: Peripheral artery disease (PAD) is the third most prevalent atherosclerotic cardiovascular disease. In 2016, costs per patient associated with PAD exceeded even the health-economic burden of coronary heart disease. Although affecting over 200 million people worldwide, a clear consensus on the most beneficial components to be included in home-based exercise programs for patients with peripheral artery disease is lacking. The aim of the study was to examine the health care use and costs caused by the 12-month patient-centered 'Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease' (TeGeCoach) program in a randomized controlled trial. METHODS: This is a two-arm, parallel-group, open-label, pragmatic, randomized, controlled clinical trial (TeGeCoach) at three German statutory health insurance funds with follow-up assessments after 12 and 24-months. Study outcomes were medication use (daily defined doses), days in hospital, sick pay days and health care costs, from the health insurers' perspective. Claims data from the participating health insurers were used for analyses. The main analytic approach was an intention-to-treat (ITT) analysis. Other approaches (modified ITT, per protocol, and as treated) were executed additionally as sensitivity analysis. Random-effects regression models were calculated to determine difference-in-difference (DD) estimators for the first- and the second year of follow-up. Additionally, existing differences at baseline between both groups were treated with entropy balancing to check for the stability of the calculated estimators. RESULTS: One thousand six hundred eighty-five patients (Intervention group (IG) = 806; Control group (CG) = 879) were finally included in ITT analyses. The analyses showed non-significant effects of the intervention on savings (first year: - 352€; second year: - 215€). Sensitivity analyses confirmed primary results and showed even larger savings. CONCLUSION: Based on health insurance claims data, a significant reduction due to the home-based TeGeCoach program could not be found for health care use and costs in patients with PAD. Nevertheless, in all sensitivity analysis a tendency became apparent for a non-significant cost reducing effect. TRIAL REGISTRATION: NCT03496948 (www. CLINICALTRIALS: gov), initial release on 23 March 2018.

Evaluation of an online suicide prevention program to improve suicide literacy and to reduce suicide stigma: A mixed methods study.

Low-threshold e-health approaches in prevention to reduce suicide stigma are scarce. We developed an online program containing video reports on lived experience of suicide and evidence-based information on suicidality. We evaluated the program by a mixed methods design. We examined pre-post-changes of program completers (n = 268) in suicide literacy, suicide stigma (self and perceived), and self-efficacy expectation of being able to seek support in psychologically difficult situations using linear mixed models. To examine reported changes and helpful program elements 12-26 weeks after program completion, we content analyzed transcripts of telephone interviews (n = 16). Program completers showed more suicide literacy (Cohen's d = .74; p < .001), higher self-efficacy expectations to seek support (d = .09; p < .01), lower self-stigma (subscales glorification/normalization: d = -.13, p = .04; isolation/depression: d = -.14; p = .04; stigma: d = -.10; p = .07; n = 168) compared to baseline. We found no significant differences in perceived suicide stigma. We identified lived experience reports, the possibility of sharing own narrative on stigma and suicidality, and information on support as helpful elements. The current online program can increase suicide literacy and self-efficacy expectations to seek support and reduce self-stigma. We recommend a larger randomized controlled trial with longer follow-up to confirm these findings.

The psychosocial situation of families caring for children with rare diseases during the COVID-19 pandemic: results of a cross-sectional online survey.

BACKGROUND: The COVID-19 pandemic is affecting many areas of life and has posed additional strains on the highly vulnerable group of caregivers of children with rare diseases (RDs). The psychosocial situation of the family caregivers deserves more attention, both in research and practice. The current study explores the distress level of caregivers of children with RDs, their psychosocial information needs, and caregiver-reported health-related quality of life (HRQoL) of children with RDs in times of the COVID-19 pandemic. METHODS: Data from a cross-sectional online survey conducted within the German CARE-FAM-NET project (children affected by rare diseases and their families-network) between March and August 2020 were examined. The study sample included 149 family caregivers, mostly mothers (83.2%) of 167 children with RDs. The survey assessed demographic and disease-related characteristics, distress and everyday problems of caregivers (Distress Thermometer for Parents; scale 0-10), psychosocial information needs (self-developed items; scale 0-100), and caregiver-reported HRQoL of the children with RDs (DISABKIDS Chronic Generic Measure, short-form; scale 0-100). Using descriptive statistics, we analyzed the psychosocial situation of families during the COVID-19 pandemic. We further conducted correlation analysis to investigate interrelations. RESULTS: The distress level among caregivers was high (M = 6.84, SD = 2.43); 89.6% reported clinical distress (≥ 4). Everyday problems (e.g., sleep problems, fatigue, being out of shape, fears, feeling tense or nervous, and worry) were frequent. Caregivers reported a wide range of psychosocial information needs. In about half of the children (49.5%), caregiver-reported HRQoL was low, while average HRQoL (M = 58.7, SD = 19.5) was comparable to parent-reported norm data of children with severe clinical conditions. Distress correlated positively with psychosocial information needs (r = 0.40), and negatively with the caregiver-reported HRQoL of the children (r = - 0.46). CONCLUSIONS: This study indicates a high psychosocial burden on family caregivers of children with RDs during the early COVID-19 pandemic, characterized by high distress levels and wide-ranging everyday problems, unmet psychosocial information needs, and reduced caregiver-reported HRQoL in children with RDs. The findings highlight the ongoing need for target group-specific, low-threshold support services (e.g., websites) during and after the pandemic.

Effects of walking impairment on mental health burden, health risk behavior and quality of life in patients with intermittent claudication: A cross-sectional path analysis.

INTRODUCTION: Intermittent claudication is the leading symptom of peripheral artery disease (leg pain when walking). The present study investigates the extent to which walking impairment is associated with health-related quality of life, mental health and health risk behavior. METHODS: A theory-based, cross-sectional path model was empirically examined using pre-intervention baseline data from a multicenter, randomized-controlled trial of patients with intermittent claudication (PAD-TeGeCoach). Data were available from 1 696 patients who completed a battery of questionnaires between April 14, 2018 and March 12, 2019, including measures of walking impairment (Walking Impairment Questionnaire), health-related quality of life (SF-12), mental burden (GAD-7, PHQ-9), nicotine- and alcohol-related risk behavior (Fagerström-Test, AUDIT-C). Sociodemographic characteristics and comorbid conditions were included in the postulated model a priori to minimize confounding effects. RESULTS: Walking impairment was associated with an increase in depressive (ß = -.36, p < .001) and anxiety symptoms (ß = -.24, p < .001). The prevalence of depressive and anxiety symptoms was 48.3% and 35.5%, respectively, with female patients and those of younger age being at greater risk. Depressive symptoms were predictive of an increased tobacco use (ß = .21; p < .001). Walking impairment had adverse effects on physical quality of life, both directly (ß = .60, p < .001) and indirectly mediated through depressive symptoms (ß = -.16, p < .001); and indirectly on mental quality of life mediated through depressive (ß = -.43, p < .001) and anxiety symptoms (ß = -.35, p < .001). DISCUSSION: The findings underscore the need for a comprehensive treatment strategy in patients with intermittent claudication. Measures to improve walking impairment (e.g. exercise training) are key to enhance quality of life and should be the primary treatment. As a key mediator of mental quality of life, depressive and anxiety symptoms should be addressed by rigorously including mental health treatment. Risky health behaviors should be approached by promoting behavior change (e.g. smoking cessation) as a secondary prevention of peripheral artery disease.

Measuring walking impairment in patients with intermittent claudication: psychometric properties of the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire.

OBJECTIVES: Patient-reported outcome measures can facilitate the assessment of walking impairment in peripheral artery disease patients with intermittent claudication in clinical trials and practice. The aim of this study was to test the psychometric properties of the German version of the 'Walking Estimated-Limitation Calculated by History' (WELCH) questionnaire. METHODS: The assessed properties included feasibility, test-retest reliability, construct validity (i.e., convergent, divergent and known-groups validity) and responsiveness using classic psychometric methods. Psychometric properties were tested as part of a randomized controlled home-based exercise trial for patients with symptomatic peripheral artery disease at Fontaine stage IIA/B. RESULTS: Analyses were conducted in subgroups of 1,696 patients at baseline and 1,233 patients at 12-month follow-up (i.e., post-intervention) who completed the WELCH along with a battery of other self-report measures. The WELCH did not exhibit relevant floor or ceiling effects (< 15% achieved lowest or highest possible scores), showed evidence for good test-retest reliability (ICC = .81, 95% CI [.71-.88]) and was found to be well suited for self-completion by patients (< 5% missing data per item). WELCH scores showed moderate to strong correlations with related measures of walking impairment at both time points (Walking Impairment Questionnaire: r = .56 - .74; VascuQoL-25 activity subscale: r = .61 - .66) and distinguished well among patients with poor and high quality of life when adjusting for confounders (t = 13.67, p < .001, d = .96). Adequate divergent validity was indicated by a weaker correlation between the WELCH and general anxiety at both time points (GAD-7: r =  - .14 to  - .22). The WELCH improved by 6.61 points (SD = 17.04, 95% CI [5.13-8.10], d = 0.39) in response to exercise treatment and was able to identify large clinically important improvements observed on the walking distance (AUC = .78, 95% CI [.71-.84]) and speed subscales (AUC = .77, 95% CI [.68-.86]) of the Walking Impairment Questionnaire. CONCLUSIONS: The WELCH is considered a feasible, reliable and valid patient-reported outcome measure for the measurement of walking impairment in patients with peripheral artery disease. The WELCH showed evidence for responsiveness to changes in walking impairment, yet further studies are warranted to conclusively determine the WELCH's ability to detect intervention effects.

Effects of telephone-based health coaching on patient-reported outcomes and health behavior change: A randomized controlled trial.

OBJECTIVE: 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. METHODS: Patients insured at a statutory health insurance were randomized to an intervention group (IG; TBHC) and a control group (CG; usual care), using a stratified random allocation before giving informed consent (Zelen's single-consent design). The TBHC was based on motivational interviewing, goal setting, and shared decision-making and carried out by trained nurses. All outcomes were assessed yearly for three years. We used mixed effects models utilizing all available data in a modified intention-to-treat sample for the main analysis. Participants and study centers were included as random effects. All models were adjusted for age, education and campaign affiliation. RESULTS: 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'. CONCLUSION: TBHC interventions might have small effects on some patient reported and behavioral outcomes. PRACTICE IMPLICATIONS: Future research should focus on analyzing which intervention components are effective and who profits most from TBHC interventions. REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS): DRKS00000584.

Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

INTRODUCTION: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD. METHODS AND ANALYSIS: The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

Abstract spatial, but not body-related, visual information guides bimanual coordination.

Visual spatial information is paramount in guiding bimanual coordination, but anatomical factors, too, modulate performance in bimanual tasks. Vision conveys not only abstract spatial information, but also informs about body-related aspects such as posture. Here, we asked whether, accordingly, visual information induces body-related, or merely abstract, perceptual-spatial constraints in bimanual movement guidance. Human participants made rhythmic, symmetrical and parallel, bimanual index finger movements with the hands held in the same or different orientations. Performance was more accurate for symmetrical than parallel movements in all postures, but additionally when homologous muscles were concurrently active, such as when parallel movements were performed with differently rather than identically oriented hands. Thus, both perceptual and anatomical constraints were evident. We manipulated visual feedback with a mirror between the hands, replacing the image of the right with that of the left hand and creating the visual impression of bimanual symmetry independent of the right hand's true movement. Symmetrical mirror feedback impaired parallel, but improved symmetrical bimanual performance compared with regular hand view. Critically, these modulations were independent of hand posture and muscle homology. Thus, visual feedback appears to contribute exclusively to spatial, but not to body-related, anatomical movement coding in the guidance of bimanual coordination.