Construction and Evaluation of Risk Early Warning Mechanism of Physical Cognitive Decline Syndrome and Community-based Rehabilitation Management Program for Patients With Remitted Geriatric Depression
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- cognitive and intellectual function
研究概览
简要总结
This study intends to take patients with RGD as objects. Further construct a community-based rehabilitation management (CBRM) program with drug treatment, rehabilitation measures of education, psychology and exercise as its core content on the basis of evidence-based practice approach. Based on the cost-utility analysis of health economics, the health and economic benefits of the CBRM program will be evaluated, and a theoretical reference will be provided for community health institutions to carry out whole-course rehabilitation management practice and health policy formulation.
详细描述
Based on the background of population aging, the prevalence of Late life depression tends to increase, and the recurrence rate after antidepressants treatment is still as high as 35%-57%, and the disease course tends to be chronic. Therefore, the formulation and implementation of prevention and control programs have become a significant part of the government's work plan. Physical frailty symptoms such as loss of daily activities and weakness are common in patients with remitted geriatric depression (RGD), and cognitive impairment is also considered to be an independent persistent symptom of RGD patients, which are related to the fluctuation and recurrence of depressive symptoms in elderly patients. Physical cognitive decline syndrome (PCDS) can comprehensively assess the physical frailty symptoms and the degree of cognitive impairment of the elderly, and effectively predict the course of the disease and the trend of healthy development. However, studies applied to the field of emotional disorder have not been retrieved. Therefore, this study intends to take patients with RGD as objects to investigate the prevalence of PCDS, build a risk prediction model and reveal it is warning mechanisms. That is, after determinning the basis of risk factors affecting the occurence of PCDS in RGD patients, we will carry out the formulation, implementation and evaluation of the follow-up CBRM program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 60 years old or above at the time of enrollment;
- •meet the diagnostic criteria for MDD without psychotic features according to DSM-5, and depressive symptoms have been improved and remained stable for at least 2 months after treatment with SSRIs;
- •the total score of HAMD-17 is less than 7 at the time of enrollment;
- •meet the diagnostic criteria for physio-cognitive decline: 1) the total score of ADL and IADL was less than 26; 2)cognitve decline: first, subjects with severe impairment of cognitive function will be excluded (years of education ≥ 6, MMSE scores <24；years of education <6 years, MMSE total score <14). After completing a neuropsychological task, cogintive declined will be confirmed when any aspects of cognitve function is 1.5 standard deviations lower than that of normal elderly; 3) the grip strength is weakened, and the domaint hand grip strength is < 28kg for males or <18kg for females; 4)slow step speed, that is, in a space of length >10 meters, the subjects walks 6 meters from the starting point at a normal and uniform pace, and the pace is <1m/s.
- •comprehension, reading and writing skills to complete the measurements or complete them with assistance of the researchers with obstacles;
- •voluntary participation and signed informed consent.
排除标准
- •meet the diagnostic of schizophrenia, bipolar disorder, dementia;
- •comorbidity of physical diseases, such ascardiovascular and cerebrovascular diseases, rheumatoid arthritis, stroke and malignant tumors;
- •history of alcohol or drug dependence;
- •severe deformity of spine and limbs;
- •complete or partial dependence on caregivers for daily life, such as long-term bedridden, wheelchair assisted;
- •have received physical therapy or psychological treatment in the past three months;
- •currently participating in other clinical research.
研究组 & 干预措施
case group,
Patients in case group will be treated with CBRM program
干预措施: CBRM (community-based rehabilitation management) (Combination Product)
control group
the control group patients will be treated routinely as usual.
干预措施: TAR(treatment as routine) (Combination Product)
结局指标
主要结局
cognitive and intellectual function
时间窗: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
Mini-mental State Examination (MMSE), as a simple screening tool for cognitive and intellectual function decline in the elderly with a total score of 30. The results of this test is closely related to the level of education, and the normal cutoff is defined as, illiterates \>17 points, primary schools \>20 points, and middle schools and above \>24 points.
changes of the handgrip strength
时间窗: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
The grip strength of a man's dominant hand \< 28kg or a woman \< 18kg is considered to have weak grip strength. The grip strength increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.
changes of the gait speed
时间窗: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
The time it takes for the subject to walk 6 meters at normal pace from the starting point without slowing down, with a threshold for gait deceleration set to \< 1m/s. The gait speed increased compared with the baseline period, that is, the subjects' physiological function tended to recover; Instead, physiological function tends to decline.
depressive symptoms
时间窗: This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.
The Hamilton Depressive Scale (HAMD-17) which consists of 17 items will be employed to screen for depressive symptoms and evaluate the mental status and severity of depressive symptoms. Scores were calculated by totaling the responses, which can be divided into four types (Health): normal/not depressed (0-7 points), mild/subthreshold (8-13), moderate/mild (14-18), severe/moderate (19-22), and severe/very severe (\>23).
次要结局
- activity of daily living(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- working memory portion of the executive function(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- quality of life of the elderly(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- verbal functions(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- sleep quality(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- language functions(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- the word memory function(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- the balance ability of the elderly(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- visuospatial structure ability and visual memory of the elderly(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
- the executive ability and the visuospatial ability(This variable will be measured at 0 (baseline) and after 3, 6 months post-intervention.)
研究者
Duan Li
Doctor Duan
Chengde Medical University