生活方式改变的个性化电子健康计划：来自“做心脏健康先进新生成生态系统（Do CHANGE 2）”随机对照试验的结果。

Personalized eHealth Program for Life-style Change: Results From the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial.

机构信息

From the Department of Medical and Clinical Psychology, Tilburg University, and Center of Research on Psychology in Somatic diseases (CoRPS) (Broers, Widdershoven, Denollet, Lodder, Kop, Habibović); Department of Cardiology (Broers, Widdershoven, Habibović), Elisabeth-TweeSteden Hospital, Tilburg; Department of Industrial Design (Wetzels, Ayoola), Eindhoven University of Technology, Eindhoven; Onmi (Ayoola), Eindhoven, the Netherlands; and Badalona Serveis Assistencials (Piera-Jimenez), Badalona, Spain.

出版信息

Psychosom Med. 2020 May;82(4):409-419. doi: 10.1097/PSY.0000000000000802.

DOI:10.1097/PSY.0000000000000802

PMID:32176191

Abstract

OBJECTIVE

Unhealthy life-style factors have adverse outcomes in cardiac patients. However, only a minority of patients succeed to change unhealthy habits. Personalization of interventions may result in critical improvements. The current randomized controlled trial provides a proof of concept of the personalized Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) 2 intervention and evaluates effects on a) life-style and b) quality of life over time.

METHODS

Cardiac patients (n = 150; mean age = 61.97 ± 11.61 years; 28.7% women; heart failure, n = 33; coronary artery disease, n = 50; hypertension, n = 67) recruited from Spain and the Netherlands were randomized to either the "Do CHANGE 2" or "care as usual" group. The Do CHANGE 2 group received ambulatory health-behavior assessment technologies for 6 months combined with a 3-month behavioral intervention program. Linear mixed-model analysis was used to evaluate the intervention effects, and latent class analysis was used for secondary subgroup analysis.

RESULTS

Linear mixed-model analysis showed significant intervention effects for life-style behavior (Finteraction(2,138.5) = 5.97, p = .003), with improvement of life-style behavior in the intervention group. For quality of life, no significant main effect (F(1,138.18) = .58, p = .447) or interaction effect (F(2,133.1) = 0.41, p = .67) was found. Secondary latent class analysis revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible.

CONCLUSIONS

The personalized eHealth intervention resulted in significant improvements in life-style. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioral intervention program. Incorporating eHealth life-style programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit.

TRIAL REGISTRATION

https://clinicaltrials.gov/ct2/show/NCT03178305.

摘要

目的

不健康的生活方式因素会对心脏病患者产生不良后果。然而，只有少数患者能够成功改变不健康的习惯。个性化干预可能会带来关键的改善。目前的随机对照试验提供了个性化心脏健康高级新一代生态系统（Do CHANGE）2 干预措施的概念验证，并评估了随着时间的推移对 a）生活方式和 b）生活质量的影响。

方法

从西班牙和荷兰招募了 150 名心脏病患者（平均年龄=61.97±11.61 岁；28.7%为女性；心力衰竭患者 33 名；冠状动脉疾病患者 50 名；高血压患者 67 名），并将他们随机分为“Do CHANGE 2”或“常规护理”组。Do CHANGE 2 组接受了 6 个月的门诊健康行为评估技术，并结合了 3 个月的行为干预计划。线性混合模型分析用于评估干预效果，潜在类别分析用于二次亚组分析。

结果

线性混合模型分析显示，生活方式行为的干预效果显著（F 交互作用（2,138.5）=5.97，p=0.003），干预组的生活方式行为得到了改善。对于生活质量，没有发现显著的主效应（F（1,138.18）=0.58，p=0.447）或交互效应（F（2,133.1）=0.41，p=0.67）。二次潜在类别分析显示，每个结果测量都有不同的患者亚组。该干预措施被认为是有用且可行的。