Effect of a novel designed intensive patient care program on cognitive impairment, anxiety, depression as well as relapse free survival in acute ischemic stroke patients: a randomized controlled study

Objective: We aimed to evaluate the influence of a novel designed intensive patient care program (IPCP) on cognitive impairment, anxiety, depression and relapse-free survival (RFS) in acute ischemic stroke (AIS) patients. Methods: Two hundred forty-two AIS patients were consecutively recruited in this randomized controlled study and randomly allocated to IPCP group or control group as 1:1 ratio. Patients received IPCP and conventional treatment in IPCP group, while received usual education, cognitive rehabilitation training and conventional treatment in control group for 12-month intervention. Cognitive impairment, anxiety and depression were assessed by Mini-Mental State Examination (MMSE), Hospital Anxiety and Depression Scale (HADS) anxiety (HADS-A), and HADS depression (HADS-D) at baseline (M0), month (M)3, M6 and M12. After intervention, patients were followed up until 2018/7/30 and RFS was calculated. Results: IPCP increased MMSE score at M12 and change of MMSE score (M12-M0), while decreased cognitive impairment rate at M12. For anxiety, decreased change of HADS-A score (M12-M0) and lower anxiety rate at M12 were observed in IPCP group compared to control group. For depression, decreased HADS-D score at M6 and M12, reduced change of HADS-D score (M12-M0) and lower depression rate at M12 were shown in IPCP group compared to control group. Besides, RFS was numerically longer in IPCP group compared to control group, but without statistical significance. Conclusions: IPCP presents with a positive influence on improving cognitive impairment and decreasing anxiety as well as depression, while a less effect on improving RFS in AIS patients. Abbreviation: IPCP: intensive patient care program; RFS: relapse free survival; AIS: acute ischemic stroke; MRA: magnetic resonance angiography; ITT: intention-to-treat; LOCF: last observation carried forward

研究目的：本研究旨在评估一款全新设计的强化患者照护方案（intensive patient care program，IPCP）对急性缺血性脑卒中（acute ischemic stroke，AIS）患者认知障碍、焦虑、抑郁及无复发生存期（relapse-free survival，RFS）的影响。
研究方法：本随机对照研究连续纳入242例AIS患者，按1:1比例随机分配至IPCP组与对照组。IPCP组患者接受强化患者照护方案联合常规治疗，对照组则接受常规健康教育、认知康复训练及常规治疗，干预周期均为12个月。分别于基线（M0）、第3个月（M3）、第6个月（M6）及第12个月（M12）采用简易精神状态检查表（Mini-Mental State Examination，MMSE）、医院焦虑抑郁量表焦虑维度（Hospital Anxiety and Depression Scale anxiety，HADS-A）及医院焦虑抑郁量表抑郁维度（HADS depression，HADS-D）评估患者的认知障碍、焦虑及抑郁状态。干预结束后对患者进行随访至2018/7/30，并计算其无复发生存期。
研究结果：与对照组相比，IPCP组患者在M12时的MMSE评分及MMSE评分变化量（M12-M0）均显著升高，同时M12时的认知障碍发生率显著降低。在焦虑维度，IPCP组患者的HADS-A评分变化量（M12-M0）更低，且M12时的焦虑发生率显著低于对照组。在抑郁维度，IPCP组患者在M6及M12时的HADS-D评分更低，HADS-D评分变化量（M12-M0）亦显著降低，且M12时的抑郁发生率同样低于对照组。此外，IPCP组患者的无复发生存期较对照组长，但差异无统计学意义。
研究结论：强化患者照护方案对改善急性缺血性脑卒中患者的认知障碍、缓解焦虑与抑郁状态具有积极作用，但对改善其无复发生存期的效果相对有限。
缩略语说明：IPCP：强化患者照护方案（intensive patient care program）；RFS：无复发生存期（relapse-free survival）；AIS：急性缺血性脑卒中（acute ischemic stroke）；MRA：磁共振血管造影（magnetic resonance angiography）；ITT：意向性治疗（intention-to-treat）；LOCF：末次观测结转法（last observation carried forward）