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NCT06155591 | NOT YET RECRUITING | Complex and Chronic Pluripathology


Case Management of Complex Pluripathology in Primary Care
Sponsor:

José Ignacio Recio Rodriguez

Information provided by (Responsible Party):

José Ignacio Recio Rodriguez

Brief Summary:

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.

Condition or disease

Complex and Chronic Pluripathology

Intervention/treatment

Community Nurse Case Manager (CNCM)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 212 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Effectiveness of the Community Nurse Case Manager in Primary Care for Complex and Pluripathological Chronic Dependent Patients: Study Protocol
Actual Study Start Date : 2024-01
Estimated Primary Completion Date : 2025-04
Estimated Study Completion Date : 2025-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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

Case Management of Complex Pluripathology in Primary Care

Location Details

NCT06155591


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