Prehabilitation of Elderly Frail or Pre-frail Patients Prior to Elective Surgery - a Randomized Controlled Multicenter Study (PRAEP-Go)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,199
- 试验地点
- 23
- 主要终点
- Degree of care dependency
研究概览
简要总结
The aim of the study is to evaluate the effect of a shared decision-making conference and three-week prehabilitation program on the outcome "care dependency" one year after surgery. The cost-effectiveness of the intervention will also be evaluated in this N = 1400 patient, national multicenter, assessor-blinded, randomized, pragmatic, controlled, parallel-group, clinical trial.
The objective of PRÄP-GO is to establish and employ a suitable preoperative case-care management system to improve the short and long-term outcome of elderly surgical patients with signs of a frailty syndrome, improving postoperative quality of life and reducing care dependency by a three-week individualized prehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study patients:
- •Inclusion Criteria:
- •Age ≥ 70 years
- •Consent by Patient or Legal Representative
- •Elective surgery planned
- •Expected anesthesia duration≥ 60 min
- •Statutory health insurance
- •Frailty syndrome (≥1 positive out of 5 standardized parameters according to the Physical Frailty Phenotype according to Fried et. al.)
排除标准
- •Severe cardiac or pulmonary disease (NYHA IV, Gold IV)
- •Intracranial interventions
- •Moribund patients (palliative situation)
- •Not enough language skills
- •Participation in another interventional rehabilitation study or other interventional clinical trial that has not been approved by the study management committee (Exception: Participation in adjuvant intervention study)
研究组 & 干预措施
Standard of Care
Prefrail and frail patients receive no prehabilitation, but receive standard of care
Prehabilitation
Prefrail and frail patients receive prehabilitation (new form of care)
干预措施: Prehabilitation- new form of care (Behavioral)
结局指标
主要结局
Degree of care dependency
时间窗: Up to one year
Assessment results in a degree of care dependency from personal help according to the German dependency assessment (= "Neues Begutachtungs-Assessment" (NBA)) (Wingenfeld et al., 2008). The results of the assessments ranges between 0 and 100 points, which are transformed into a 0-5 ordinal scale. Higher points in the assessments indicate higher demand of care dependency. Accordingly, higher numbers on the ordinal scale indicate a higher level of care dependency as defined in the German statutory care insurance program.
次要结局
- Arm circumference(Up to one year)
- Length of stay Intensive Care Unit(Participants are followed up for the duration of rehabilitation, an expected average of 1 day])
- Muscle strength(Up to one year)
- Functional mobility(Up to one year)
- Every mobility(Up to one year)
- Change in NBA score(Up to one year)
- NBA domain change(Up to one year)
- Surrogate for Neurocognitive Disorder (NCD)(Up to one year)
- Screening tool for cognitive vulnerability(Up to one year)
- Dementia risk assessed by MOCA(Up to one year)
- Extent of involvement in shared decision-making process(At the beginning of the observation)
- Barthel Index(Up to one year)
- Delirium(Up to one year)
- Frailty(Up to one year)
- Perioperative complications by Clavien-Dindo(Up to hospital discharge)
- Autonomy Preference(At the beginning of the observation)
- Calf circumference(Up to one year)
- Nutritional Status(Up to one year)
- Change in body weight(Up to one year)
- Instrumental Activities of daily living (IADL)(Up to one year)
- Functional endurance(Up to one year)
- Function of the respiratory system(Up to one year)
- Depression(Up to one year)
- Anxiety(Up to one year)
- Health related quality of life(Up to one year)
- Disability by WHODAS 2.0(Up to one year)
- Falls(Up to one year)
- Fear of Falling(Up to one year)
- Satisfaction with the intervention: ZUF-8(Up to one year)
- Mortality(Up to one year)
- Stair climbing speed(Up to one year)
- Timed Up & Go Test (TUG(Up to one year)
- Postoperative functional mobility(Up to one year)
- Admission Intensive Care Unit (ICU) Admission rate on Intensive Care Unit (ICU)(Participants are followed up for the duration of rehabilitation, an expected average of 1 day])
- Duration of hospital stay(Participants are followed up for the duration of rehabilitation, an expected average of 7 days])
研究者
Claudia Spies
Univ.- Prof. Dr. Claudia Spies
Charite University, Berlin, Germany