Cost-effectiveness of a Functional and Respiratory Rehabilitation Intervention in Patients Who Receive an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Cost of interventions assesed by antimicrobials used in infectious complications and chemotherapy conditioning.
研究概览
简要总结
The objective of the study is to evaluate the benefits and costs of a comprehensive rehabilitation program (physical, psychological, social and educational) for patients receiving hematopoietic stem cell transplantation (HSCT). It is a prospective longitudinal study with a control group. Patients will be included who will perform a transplant in the hospital environment. The variables of the study will be: number and type of complications, days of hospitalization, readmissions, economic cost of the program, exercise tolerance, assessment of muscular atrophy, health related quality of life, knowledge and self-management of the disease, all of them adjusted for the variables age, sex and hematological disease, as well as comorbidities. The evaluations will be performed before transplantation (between one and three months before), during the conditioning phase (intensive chemotherapy), before discharge, after immediate discharge and after discharge up to one year. The nursing team will perform the patient's therapeutic education, stimulation for physical activity, as well as evaluation and follow-up measures. Early detection of the needs of the rest of the rehabilitation team will be carried out. There will be a support function for the physiotherapist in regard to physical activity. In Spain there is no interdisciplinary team that provides comprehensive care and rehabilitation to this type of patients and few studies are dedicated to rehabilitation beyond physiotherapy as a preventive tool for future disabilities.
详细描述
Working hypothesis
-
- Patients who receive a Hematopoietic Stem Cell Transplantation (HSCT) who follow a comprehensive rehabilitation program, have fewer post-transplant complications, reduce the number of hospital stay days, and return to their daily lives more quickly.
-
- The economic costs derived from the incorporation of the rehabilitation program will be lower than the savings caused by the decrease in complications, hospital stay and consumption of health resources.
Goals
Main objectives
- To evaluate the quality of life related to health in the hematological patient who has received a HSCT and on which a new preventive functional rehabilitation intervention (other than physiotherapy) is applied.
- To compare the number and type of respiratory and other complications after HSCT among the intervention group compared to a control group.
- Estimate the effects of the rehabilitation program on tolerance to exercise in the short, medium and long term, as well as detect the change in lifestyle if this occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
86 patients in experimental group. 104 patients retrospectively collected from the inclusion of the first patient of the intervention group.
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant hemopathies candidates for HSCT.
- •controlled pain.
- •who sign informed consent.
排除标准
- •Severe musculoskeletal or neurological alterations prior to HSCT.
- •Severe psychiatric problems.
- •Language barrier.
研究组 & 干预措施
pre active HSCT
Candidates for transplantation of hematopoietic progenitors since May 12, 2012, regardless of sex and age, who agree to participate in the study and sign informed consent.
In the pre-transplantation visit with the physiotherapist: Measures of muscle mass and strength, quality of life questionnaires, program presentation, fitness assessment and lifestyle determination. The exercises will be personalized, stimulating your practice before admission and involving the family. During admission, the team will encourage the patient to remain active by adapting to the symptoms. At discharge, measures of resistance, exercise tolerance and quality of life at discharge, in the month after discharge, 3 months after discharge, 6 months after discharge and 12 months after discharge.
干预措施: Specific program functional and respiratory rehabilitation (Other)
control group
Patients' candidates for transplantation of hematopoietic progenitors prior to May 12, 2012, regardless of gender and age, who meet the inclusion criteria and are collected correlatively until completing 104 subjects.
Clinical history review to calculate the days of hospitalization in the different hospitalization units during the transplant. As well as the number and type of complications and the use of health resources. Status vitae. Baseline review of functional tests and exercise tolerance.
结局指标
主要结局
Cost of interventions assesed by antimicrobials used in infectious complications and chemotherapy conditioning.
时间窗: Admission
expressed in euros
Cost of interventions assesed by the number (number), characteristics and incidence of the immediate complications of HSCT
时间窗: Admisssion
Incidence expressed as a percentage. Comparison between the two groups (total number and percentage)
Cost of interventions assesed by the cost of hospitalization for HSCT
时间窗: Admission
For the calculation the days of hospitalization in each hospitalization unit care are counted. Then, the total number of days spent in each unit (D): (intensive care unit, ICU (A), isolation chamber (B), single room (C). The cost of hospitalization for HSCT: (a: price / day in the ICU, b: price / day in isolation chamber, c: price / day in single room, in euros). Dd = (Aa) + (Bb) + (Cc), in euros.
Cost of interventions assesed by the cost incorporation of a physiotherapist into the team
时间窗: Admission
To calculate the cost, a physiotherapist will be hired 4 hours / day for the intervention group. Day of hospitalization for the transplant (D) multiplied by the cost per day of the physiotherapist (euros).
次要结局
- Muscle atrophy: fat free mass index; measured by electrical bioimpedance(Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
- Muscular atrophy measured by hand grip(Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
- Mortality associated to HSCT(During the HSCT process, and up to a 2-year post HSCT follow-up.)
- Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) lymfhoma questionnaire (Scale info can be included in the description.)(Admission.)
- Adherence to the program and evaluation of the knowledge acquired by the patient.(Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
- Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) leukemia questionnaire (Scale info can be included in the description.)(Admission.)
- Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) multiple myeloma questionnaire (Scale info can be included in the description.)(Admission.)
- Exercise tolerance(Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
- Muscle atrophy: body mass index; measured by electrical bioimpedance(Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
- Referred quality of life: quality of life as assessed by the FACT (Functional Assessment of Cancer Therapy) Bone marrow transplant (Scale info can be included in the description.)(Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
- Referred quality of life: Levels of anxiety and depression will also be assessed using the Hospital Anxiety and Depression Scale (HAD) questionnaire. (Scale info can be included in the description.)(Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
- Muscle atrophy: loss or gain of weight; measured by electrical bioimpedance(Admission. Prior to hospital discharge or the same day discharge day. 1,3, 6, 12 months post discharge.)
研究者
Yolanda Torralba Garcia
Clinical investigator. BSN.
Hospital Clinic of Barcelona