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.

Can Adherence to and Persistence with Inhaled Long-acting Bronchodilators Improve the Quality of Life in Patients with Chronic Obstructive Pulmonary Disease? Results from a German Disease Management Program.

BACKGROUND AND OBJECTIVE: Adherence to and persistence with inhaled long-acting bronchodilators (ILAB), is commonly considered to be a relevant driver of perceived health-related quality of life (HRQoL) in chronic obstructive pulmonary disease (COPD), but the topic is rarely studied with real-world data. Using survey and health insurance claims data, this study investigates the effect of adherence to and persistence with ILAB on EQ-5D-5L visual analog scale (VAS) in ILAB users who were enrolled in the German disease management programs (DMP) for COPD. METHODS: Included ILAB users were aged ≥ 18 years, continuously insured with AOK Bavaria and enrolled in the DMP for COPD. Adherence to ILAB [proportion of days covered (PDC); PDC ≥ 80%], and persistence (days of uninterrupted ILAB therapy) were assessed in the year preceding the study's HRQoL questionnaire. In a cross-sectional design we applied quasi-Poisson models with log link function and subgroup analyses. The robustness of results was analyzed with comprehensive sensitivity analyses. RESULTS: Patients with PDC ≥ 80% had 2.96% higher VAS scores than patients with lower PDCs. From all analyses, patients with GOLD stage III had the highest effects from PDC ≥ 80% (5.33% increased VAS). Patients without heart failure profited significantly more from PDC ≥ 80% (+ 4.34% vs - 2.88%) and from an additional persistent day (+ 0.01% vs - 0.01%) than patients with heart failure. CONCLUSIONS: Overall, ILAB users significantly profited from PDC ≥ 80%, but not from continuous PDC or persistent days. In secondary subgroup analyses, patients with GOLD stage III and patients without heart failure particularly profited from PDC ≥ 80%. Only patients without heart failure particularly profited from more persistent days. Because identified effects were small and often not robust, advancing adherence and persistence alone may not improve the German DMP for COPD substantially.

How to make value-based health insurance designs more effective? A systematic review and meta-analysis.

Value-based health insurance designs (VBIDs) are one approach to increase adherence to highly effective medications and simultaneously contain rising health care costs. The objective of this systematic review was to identify VBID effects on adherence and incentive designs within these programs that were associated with higher effects. Eight economic and medical databases were searched for literature. Random effects meta-analyses and mixed effects meta-regressions were used to synthesize VBID effects on adherence. Thirteen references with evaluation studies, including 12 patient populations with 79 outcomes, were used for primary meta-analyses. For qualitative review and sensitivity analyses, up to 19 references including 20 populations with 119 outcomes were used. Evidence of synthesized effects was good, because references with high risk of bias were excluded. VBIDs significantly increased adherence in all indication areas. Highest effects were found in medications indicated in heart diseases (4.05%-points, p < 0.0001). Each additional year increased effects by 0.15%-points (p < 0.01). VBIDs with education were more effective than without education, but the difference was not significant. Effects of VBIDs with full coverage were more than twice as high as effects of VBID without that option (4.52 vs 1.81%-points, p < 0.05). These findings were robust in most sensitivity analyses. It is concluded that VBID implementation should be encouraged, especially for patients with heart diseases, and that full coverage was associated with higher effects. This review may provide insight for policy-makers into how to make VBIDs more effective.

Determinants of adherence and effects on health-related quality of life after myocardial infarction: a prospective cohort study.

BACKGROUND: Adherence to recommendations and medication is deemed to be important for effectiveness of case management interventions. Thus, reasons for non-adherence and effects on health-related quality of life (HRQoL) should be fully understood. The objective of this research was to identify determinants of non-adherence to medication and recommendations, and to test whether increased adherence improved HRQoL in patients after myocardial infarction (MI) in a case management intervention. METHODS: Data were obtained from the intervention group of the KORINNA study, a randomized controlled trail of a nurse-led case management intervention with targeted recommendations in the elderly after MI in Germany. Reasons for non-adherence were described. Logistic mixed effects models and OLS (ordinary least squares) were used to analyze the effect of recommendations on the probability of adherence and the association between adherence and HRQoL. RESULTS: One hundred and twenty-seven patients with 965 contacts were included. Frequent reasons for non-adherence to medication and recommendations were "forgotten" (22%; 11%), "reluctant" (18%; 18%), "side effects" (38%; 7%), "the problem disappeared" (6%; 13%), and "barriers" (0%; 13%). The probability of adherence was lowest for disease and self-management (38%) and highest for visits to the doctor (61%). Only if patients diverging from prescribed medication because of side effects were also considered as adherent, 3-year medication adherence was associated with a significant gain of 0.34 quality-adjusted life years (QALYs). CONCLUSIONS: Most important determinants of non-adherence to medication were side effects, and to recommendations reluctance. Recommended improvements in disease and self-management were least likely adhered. Medication adherence was associated with HRQoL. TRIAL REGISTRATION: Current Controlled Trials ISRCTN02893746 , retrospectively registered, date assigned 27/03/2009.

Claims Data Analysis of Tumor Necrosis Factor Inhibitor Treatment Dosing Among Patients with Rheumatoid Arthritis: A Systematic Review of Methods.

BACKGROUND: With tumor necrosis factor inhibitors, changes of dosing, switching between drugs, insufficient adherence, and persistence are frequent in rheumatoid arthritis. Because this is often associated with decreased efficiency and increased costs, dosage analyses based on claims data are of increasing interest for healthcare providers and payers. Nevertheless, no standardized methods exist to ensure high-quality research. OBJECTIVE: In this review, we compare and discuss applied methods in claims data-based dosage analyses of tumor necrosis factor inhibitor prescriptions in patients with rheumatoid arthritis. METHODS: A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The dosage analysis methods performed within the selected studies were classified into switching, persistence, adherence, and dosage-change analyses, and were then compared and finally discussed. RESULTS: A total of 45 studies were found to be relevant. In most studies, a change in dose or persistence was evaluated, followed by switching and adherence analyses. Analyses of changed dose exhibit the most extensive variation of methods. We divided them into three principal methods, where a specified reference dose is compared with (1) the last dose, (2) any dose, or (3) all doses. CONCLUSION: The systematic review identified a high variation of methods. Our results may be helpful for choosing appropriate methods in future studies. The results also demonstrate the need for evidence-based recommendations of methods used in claims data research.