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Case Management of Complex Pluripathology in Primary Care

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06155591
Acronym
ENGESCC
Enrollment
212
Registered
2023-12-04
Start date
2024-01-31
Completion date
2025-07-31
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex and Chronic Pluripathology

Keywords

Multimorbidity, Functional Dependence, Case Management, Primary Health Care, Nursing

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.

Interventions

OTHERCommunity Nurse Case Manager (CNCM)

Their action protocol has been designed and sequenced according to the circumstances in which the Complex and Pluripathological Chronic Patient finds themself: * Pre-hospital discharge. The hospital Nurse Case Manager (HNCM) will contact the CNCM to inform of the imminent hospital discharge. * Hospital discharge: A comprehensive nursing assessment of the CPCP based on Marjory Gordon's functional patterns will be carried out. * Planned visits: An infographic will be provided to identify signs and symptoms of decompensation/exacerbation and a direct dial telephone number. * Proactive telephone follow-up: The CNCM will make comfort calls every week for the first month, every 15 days until the 3-months visit and every month until the 6- and 12-months visits. * Exacerbations/decompensations: An appointment will be arranged with their Primary Care physician. * Hospital readmission: The CNCM will be kept informed of the process through the HNCM and CPCP's digital clinical history.

Sponsors

Consejo General de Colegios Oficiales de Enfermería de España
CollaboratorUNKNOWN
Instituto Español de Investigación Enfermera
CollaboratorUNKNOWN
Gerencia Regional de Salud de Castilla y Leon
CollaboratorOTHER
José Ignacio Recio Rodriguez
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Activities of daily living0,1,3,6,12 monthsEvaluated 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 performance0,3,6,12 monthsEvaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). A score of 26 or higher is considered normal
Health-related quality of life0,3,6,12 monthsEvaluated 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.

Secondary

MeasureTime frameDescription
Therapeutic adherence1,3,6,12 monthsEvaluated by a scale to assess the patient's skills and knowledge of the prescribed treatment, adapted from the DRUGS and Med-Take scales. A score \> 75%, the patient is adherence to treatment.
User satisfaction1,3,6,12 monthsEvaluated by Satisfad Questionnaire 14. Score (0-42). Each item is assessed through a 4-level Likert scale. A higher score means a higher level of satisfaction
Degree of dyspnoea0,1,3,6,12 monthsEvaluated by modified Medical Research Council Scale. This consists of 5 levels. The higher the level, the lower the tolerance to activity due to dyspnoea
Symptoms attributable to heart disease0,1,3,6,12 monthsEvaluated by the New York Heart Association Functional Classification. This consists of 4 Class. Class I patients have no symptoms, while those in classes II, III and IV have mild, moderate and severe symptoms, respectively
Number of hospital admissions1,3,6,12 monthsCollected from the patient's medical history
Number of drugs chronically prescribed0,1,3,6,12 monthsCollected from the patient's medical history
Capillary glycosylated haemoglobin0,3,6,12 monthsMeasured in %
Height0 monthsCollected from the patient's medical history
Body mass index0 monthsCollected from the patient's medical history
Blood pressure systolic and diastolic0,1,3,6,12 monthsMeasured in mmHg
Oxygen saturation0,1,3,6,12 monthsMeasured in %
Heart rate0,1,3,6,12 monthsMeasured in bpm
Capillary blood glucose0,1,3,6,12 monthsMeasured in mg/dl
Weight0 monthsCollected from the patient's medical history
Frailty0,1,3,6,12 monthsEvaluated by FRAIL questionnaire. This consists of 5 simple questions on fatigue, endurance, ambulation, comorbidity and weight loss. Persons scoring 1 point or more are considered frail
Primary caregiver overload0,3,6,12 monthsEvaluated by the Zarit scale. Score (22 - 110). A score ≥47 points being considered overburden

Contacts

Primary ContactVirginia Iglesias Sierra
viglesiass@saludcastillayleon.es630098762

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026