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临床试验/NCT06155591
NCT06155591尚未招募不适用

Effectiveness of the Community Nurse Case Manager in Primary Care for Complex and Pluripathological Chronic Dependent Patients: Study Protocol

José Ignacio Recio Rodriguez0 个研究点目标入组 212 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
212
主要终点
Activities of daily living

研究概览

简要总结

Aims

To assess the effect of the implementation of the Community Nurse Case Manager (CNCM) in the care of complex and pluripathological chronic patients (CPCP) with dependence, from Primary Care, on functional capacity, cognitive performance, quality of life, consumption of health resources, clinical parameters, overload of the main caregiver, and satisfaction of the user and/or caregiver.

Design

Pre- and post-intervention quasi-experimental study in CPCP.

Methods

212 subjects will be recruited from two urban health centers in Salamanca (Spain) with complex and chronic pluripathology (CCP) associated to cardiac, respiratory pathology and/or diabetes mellitus, who are dependent and have a planned hospital discharge.

An initial evaluation will be performed after hospital discharge in both groups, including: anamnesis (prescribed drugs and symptoms attributable to the underlying pathology), physical examination (blood pressure, heart rate and oxygen saturation), determination of capillary HbA1c, and assessment of functional capacity (Barthel), cognitive performance (MoCA), quality of life (COOP-WONCA), therapeutic adherence and overload of the main caregiver (Zarit). There will be another evaluation at 3,6 and 12 months, when these same variables will be collected, in addition to the number of readmissions in each period and the satisfaction of the user and/or caregiver (Satisfad 14). The nurse from the Primary Care team will provide both groups with the usual care contemplated for this type of patient in the Portfolio of Services of the Health Service of Castilla y León. Additionally, in the experimental group there will be telephone follow-up and the caregiver will be trained on the signs of decompensation and the care required.

Conclusion

The deployment of the NCM (Nurse Care Manager) in Primary Care will provide comprehensive and individualized care to the CPCP and the main caregiver with proactive monitoring. In addition, it will reinforce the involvement of the caregiver and the patient to improve their self-care and will detect early signs and symptoms of decompensation to avoid hospital readmissions.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Dependent complex and pluripathological chronic patients (CPCP) with associated cardiac and/or respiratory pathologies and/or diabetes mellitus
  • Frail ≥1 point
  • Require a main caregiver to perform basic activities of daily living (ABVD)
  • Barthel ≤60 points and/or grade II or III dependency recognised by Social Services
  • Are immobilised at home and/or require social resource management
  • Agree to sign (themselves or their legal guardians) the informed consent for participation in the study

排除标准

  • Patients with other pathologies associated with complex pluripathology
  • With non-habitual caregivers
  • Barthel ≥60 points or grade I dependency recognised by Social Services
  • Who reside outside the area assigned to the Garrido Sur and Miguel Armijo health centres despite being assigned to them

结局指标

主要结局

Activities of daily living

时间窗: 0,1,3,6,12 months

Evaluated by Barthel index. Score (0-100). A person is considered totally dependent if it is ˂20 points; severely dependent if it is between 25-60 points; moderately dependent if it is between 65-90 points; and mildly dependent if it is equal to 95 points

Cognitive performance

时间窗: 0,3,6,12 months

Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). A score of 26 or higher is considered normal

Health-related quality of life

时间窗: 0,3,6,12 months

Evaluated by Health-related quality of life (COOP-WONCA test). This consists of a drawing representing a level of functioning on seven areas with a 5-level Likert scale. Higher scores express worse levels of functioning/well-being.

次要结局

  • Primary caregiver overload(0,3,6,12 months)
  • Therapeutic adherence(1,3,6,12 months)
  • User satisfaction(1,3,6,12 months)
  • Degree of dyspnoea(0,1,3,6,12 months)
  • Symptoms attributable to heart disease(0,1,3,6,12 months)
  • Number of drugs chronically prescribed(0,1,3,6,12 months)
  • Frailty(0,1,3,6,12 months)
  • Number of hospital admissions(1,3,6,12 months)
  • Weight(0 months)
  • Height(0 months)
  • Body mass index(0 months)
  • Blood pressure systolic and diastolic(0,1,3,6,12 months)
  • Heart rate(0,1,3,6,12 months)
  • Oxygen saturation(0,1,3,6,12 months)
  • Capillary blood glucose(0,1,3,6,12 months)
  • Capillary glycosylated haemoglobin(0,3,6,12 months)

研究者

发起方
José Ignacio Recio Rodriguez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

José Ignacio Recio Rodriguez

Full Professor at the University. PhD

University of Salamanca

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