Telephone Health Coaching and Remote Exercise Monitoring (TeGeCoach) in Peripheral Arterial Occlusive Disease­a Randomized Controlled Trial.

BACKGROUND: Supervised exercise programs are commonly 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 program (TeGeCoach) on self-reported walking ability in patients with IC. METHODS: In a pragmatic, multicenter, randomized and controlled trial (registration number NCT03496948), 1982 patients with symptomatic IC, insured by one of three German statutory health-insurance carriers, 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 12 and 24 months after the start of the intervention (intention-to-treat analysis). The secondary outcomes were health-related quality of life, symptoms of depression or anxiety, health competence, patient activation, alcohol use, and nicotine dependence. RESULTS: There was a significant difference between arms in favor of TeGeCoach in the WIQ (p<0.0001). Patients in the TeGeCoach arm had WIQ scores that were 6.30 points higher at 12 months (Bonferroni-corrected 95% CI [4.02; 8.59], Cohen's d = 0.26) and 4.55 points higher at 24 months ([2.20; 6.91], d = 0.19). They also fared better in some of the secondary outcomes at 12 months, including physical health-related quality of life and patient activation, with at least small effect sizes (d > 0.20). The average daily step count was no higher in the TeGeCoach group. CONCLUSION: The observed reductions of symptom burden indicate the benefit of home-based exercise programs in the treatment of intermittent claudication. Such programs expand the opportunities for the guideline-oriented treatment of IC. Future studies should address the effect of home-based exercise programs on clinical variables, e.g., 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.

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.

Long-term effectiveness of telephone-based health coaching for heart failure patients: A post-only randomised controlled trial.

Introduction The * Equal contributors. health-status of heart failure patients can be improved to some extent by disease self-management. One method of developing such skills is telephone-based health coaching. However, the effects of telephone-based health coaching remain inconclusive. The aim of this study was to evaluate the effects of telephone-based health coaching for people with heart failure. Methods A total sample of 7186 patients with various chronic diseases was randomly assigned to either the coaching or the control group. Then 184 patients with heart failure were selected by International Classification of Diseases (ICD)-10 code for subgroup analysis. Data were collected at 24 and 48 months after the beginning of the coaching. The primary outcome was change in quality of life. Secondary outcomes were changes in depression and anxiety, health-related control beliefs, control preference, health risk behaviour and health-related behaviours. Statistical analyses included a per-protocol evaluation, employing analysis of variance and analysis of covariance (ANCOVA) as well as Mann-Whitney U tests. Results Participants' average age was 73 years (standard deviation (SD) = 9) and the majority were women (52.8%). In ANCOVA analyses there were no significant differences between groups for the change in quality of life (QoL). However, the coaching group reported a significantly higher level of physical activity ( p = 0.03), lower intake of non-prescribed drugs ( p = 0.04) and lower levels of stress ( p = 0.02) than the control group. Mann-Whitney U tests showed a different external locus of control ( p = 0.014), and higher reduction in unhealthy nutrition ( p = 0.019), physical inactivity ( p = 0.004) and stress ( p = 0.028). Discussion Our results suggest that telephone-based health coaching has no effect on QoL, anxiety and depression of heart failure patients, but helps in improving certain risk behaviours and changes the locus of control to be more externalised.

Effectiveness of Telephone-Based Health Coaching for Patients with Chronic Conditions: A Randomised Controlled Trial.

BACKGROUND: 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. METHODS AND FINDINGS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: German Clinical Trials Register DRKS00000584.

Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial.

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.