跳至主要内容
临床试验/NCT04048980
NCT04048980Unknown不适用

Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2018年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
432
试验地点
1
主要终点
Knowledge of nurses

研究概览

简要总结

This is a quasi-experimental design with repeated observations, taken at baseline, post-intervention, and at one and three months post-intervention. Participants will be patients hospitalized with cognitive disorders o dementia and a femur fracture. The study will be developed in four general hospitals in Spain and will include 430 patients with dementia (PwD) and their informal caregivers (IC). The study sample will be assigned to the control group (n=215) from each hospital involved and will receive the standard treatment. After completing the recruitment for the control group, the investigators will start to recruit patients until experimental patient group is complete (n=215) from each hospital to whom the CARExDEM intervention will be implemented.

详细描述

The high vulnerability of PwD hospitalized generates the need to confront this challenge from a global and continuous perspective along with the clear lack of intervention studies with PwD hospitalized at a national and international level.

The aim of this study is to design, implement and evaluate the effectiveness of an intervention program for nurses looking after hospitalized patients with proximal femur fracture and dementia or cognitive impairment, in acute hospitals and its impact in quality of care, morbidity reduction, improvement of continuity of care and reduction in costs.

The study will be conducted in four traumatology units of high technology public hospitals across Spain: the autonomous communities included are Catalonia (Hospital Clinic Barcelona), Madrid (Hospital Puerta de Hierro Madrid), Cantabria (Hospital Marqués de Valdecilla) and Navarra (Complejo hospitalario de Navarra). The study will be held in a 3 year frame time.

Participants will be patients with dementia and their caregiver elected consecutively (n=432), and healthcare professionals working in the traumatology unit. All questionnaires selected are valid and reliable and widely used among studies with PwD. All questionnaires were translated already to Spanish and we have permission of the authors for using them. They are structured in Likert scaling. The whole questionnaire can be completed in 45 minutes (for patient questions) and 15 minutes (for informal caregivers).

Data will be collected by trained interviewers at hospital admission (within 24 hours), discharge, 1 moth follow up at the outpatient traumatology visit and 3 months follow up (phone call). Questionnaires have been customized in one document according to the collection phase. Questions will be responded according to patient and caregiver data.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 65
  • Hospitalized for surgery
  • Informal caregiver able to understand the recommendations of health professionals
  • Score of 5 or less in the Short Portable Mental Status Questionnaire (SPMSQ) test
  • Signed informed consent form.
  • Informal caregivers:
  • Living with the PwD or visiting at least three times per week at home or nursing home
  • Signed informed consent form.

排除标准

  • Patients younger than 65
  • Psychiatric symptoms or Korsakov syndrome
  • No signed consent form.

研究组 & 干预措施

Control Group

No Intervention

Patients with dementia or cognitive impairment and femur fracture receiving the traditional care in traumatology units.

Experimental Group

Experimental

Patients with dementia or cognitive impairment and femur fracture receiving an intervention in traumatology units.

干预措施: CARExDEM (Behavioral)

结局指标

主要结局

Knowledge of nurses

时间窗: 3 months

An "ad hoc" questionnaire was created to know the nurses knowledge of care of patients with dementia. Sociodemographic data as age, level of studies, experience in years at the hospital, and questions about self-assessment abilities,implication with patient care, patient empowerment, evaluation of self training. The questionnaire has 25 questions and applies from (all patients to no patients). It also has open questions about barriers and facilitators regarding patient education in the unit. There is no total scoring, as questions are qualitative mostly and it not considered a scale.

Informal Caregiver Costs

时间窗: 3 months

RUD (Resource Utilization in Dementia) questionnaire. Evaluates the caregiver's input on resource utilization. Frequency and duration of hospitalization, visits to health care professionals and type of care, medication use, use of social services, caregiver time spent with patient on basic activities and instrumental activities of daily living, caregiver work status and whether informal caregiver substitutes for paid work. Time (in hours) of dedication of informal caregiver for patient. Healthcare services used in the last month (primary care doctor or nurse, physiotherapists, social services...) There is no total scoring as it is not a scale. Costs will be estimated by multiplying the number of units for each relevant factor from the questionnaire with the corresponding unit price vector. Total costs will be measured as average monthly costs in euros.

Use of Restraints

时间窗: 3 months

Adapted questionnaire from Hammers et al. 8 items (Never - more tan once a day).7 items where each ítem is a type of restraint: Belt, chair or wheelchair with blockages (tables), handrails, adjusts sheets, infrared, sensors,door blockage in room.There is no total scoring, as items will be assessed individually to identify the type of restraint used.

Psychotropic medication

时间窗: 3 months

Records on chart about use of psychotropic medication. Name of medication administered during hospitalization or at home.

Pain assessment in dementia: MPAINAD scale

时间窗: 3 months

PAINAD scale (Pain assessment in dementia). 5 items evaluating breathing, negative vocalization, facial expression, body language and consolability. The total score ranges from 0-10 points. A possible interpretation of score is: 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain

Falls (number)

时间窗: 3 months

Record from proxy if any falls (witnessed/unwitnessed) It is considered a fall when a patient reached the floor from another level. Number of falls recorded

Functional capacity

时间窗: 3 months

Barthel Index: 10 items evaluating physical impairment; where each item scores 0-15 depending on item (0=dependent, 15 independent). Several authors have proposed guidelines for interpreting Barthel scores. Shah et al. suggested that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency. Total scoring Katz Index: 6 items. Evaluating activities by dependence or Independence. Scoring ranges from 0-6 where 0 is Low (patient very dependent and 6 High, patient very independent)

Caregiver burden

时间窗: 3 months

CRA (Caregiver reaction assessment) a 24-item instrument designed to measure the reactions of family members to caring for elderly relatives with a variety of illnesses. Items are rated on a 5-point scale (from "strongly agree" to "strongly disagree"). Caregiver's esteem (7 items);Lack of family support (5 items);Impact on finances assesses the adequacy, difficulty, and strain of finances on the caregiver and family (3 items);Impact on schedule (5 items);Impact on health assesses the caregiver's capability to provide care and health in relation to caregiving (4 items).Burden related to disrupted time (range 5-25), financial problems (range 3-15), lack of family support (range 5-25), health problems (range 4-20), and self-esteem (range 7-35). Higher=worse (greater burden)

Cognitive status

时间窗: 3 months

NPI-Q (Neuro-psychiatric inventory). 12 items evaluating psychopathology in dementia. Severity 1. = Mild (noticeable, but not a significant change) 2. = Moderate (significant, but not a dramatic change) 3. = Severe (very marked or prominent; a dramatic change). Scoring for distress: 0 = Not distressing at all Distress 0 = Not distressing at all 1. = Minimal (slightly distressing, not a problem to cope with) 2. = Mild (not very distressing, generally easy to cope with) 3. = Moderate (fairly distressing, not always easy to cope with) 4. = Severe (very distressing, difficult to cope with) 5. = Extreme or very severe (extremely distressing, unable to cope with). Total score: After all domains have been scored, adding up the total score out of a possible 144. (Less tan 20=mild problem, 20-50= moderate disturbance, 50+=severe disturbance

Comorbidity

时间窗: 3 months

Charlson comorbidity index (19 items) evaluating comorbidity. Comorbid diseases were coded as: 0=absent; 1=present. Severity was coded as: 1=not ill; 2=mildly ill; 3=moderately ill; 3=severely ill and 5=moribund. To create a scoring, the method Hutchinson and Thomas combining age and comorbidity.

次要结局

  • Psychotropic medication administration(3 months)
  • Frequency on psychotropic medication(3 months)
  • Injuries related to falls(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adelaida Zabalegui Yarnoz

Subdirector Reasearch and Education in Nursing

Hospital Clinic of Barcelona

研究点 (1)

Loading locations...

相似试验