Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Eur J Health Econ. 2024 Jun;25(4):615-629. doi: 10.1007/s10198-023-01616-4. Epub 2023 Jul 10.
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.
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.
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.
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.
NCT03496948 (www.
gov), initial release on 23 March 2018.
外周动脉疾病（PAD）是第三大常见的动脉粥样硬化性心血管疾病。2016 年，与 PAD 相关的每位患者的成本甚至超过了冠心病的健康经济负担。尽管全球有超过 2 亿人受到影响，但对于外周动脉疾病患者的家庭锻炼计划中最有益的组成部分，尚未达成明确共识。本研究的目的是在一项随机对照试验中，检查为期 12 个月的以患者为中心的“远程外周动脉疾病健康教练和远程运动监测”（TeGeCoach）计划对医疗保健使用和成本的影响。
这是一项在三个德国法定健康保险基金中进行的双臂、平行组、开放性、实用、随机、对照临床试验（TeGeCoach），在 12 个月和 24 个月后进行随访评估。研究结果是从健康保险公司的角度评估药物使用（每日规定剂量）、住院天数、病假天数和医疗保健费用。使用参与健康保险公司的索赔数据进行分析。主要分析方法为意向治疗（ITT）分析。另外还执行了其他方法（修改后的 ITT、符合方案和实际治疗）作为敏感性分析。计算随机效应回归模型以确定第一年和第二年随访的差异（DD）估计值。此外，还使用熵平衡处理两组之间基线时的现有差异，以检查计算出的估计值的稳定性。
最终有 1685 名患者（干预组（IG）=806；对照组（CG）=879）被纳入 ITT 分析。分析显示，干预对节约效果无显著影响（第一年：-352€；第二年：-215€）。敏感性分析证实了主要结果，并显示出更大的节约。
根据健康保险索赔数据，在 PAD 患者中，基于家庭的 TeGeCoach 计划在医疗保健使用和成本方面并未发现显著降低。然而，在所有敏感性分析中，都出现了非显著的成本降低效果的趋势。
NCT03496948（www.clinicaltrials.gov），于 2018 年 3 月 23 日首次发布。
