Complex and Chronic PluripathologyENGESCCNCT06155591
Case Management of Complex Pluripathology in Primary Care
A study testing Community Nurse Case Manager (CNCM) in people with Complex and Chronic Pluripathology, run by José Ignacio Recio Rodriguez.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complex and Chronic Pluripathology
- What is being tested?
- Community Nurse Case Manager (CNCM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of the Community Nurse Case Manager in Primary Care for Complex and Pluripathological Chronic Dependent Patients: Study Protocol
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.
Read more
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.
- Conditions
- Complex and Chronic Pluripathology
- Being tested
- Community Nurse Case Manager (CNCM)
- Keywords
- Multimorbidity, Functional Dependence, Case Management, Primary Health Care, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Nurse Case Manager (CNCM)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Usual care of complex and pluripathological chronic patients (CPCP) |
| Experimental Group | Experimental | Usual care of CPCP + Community Nurse Case Manager (CNCM) standardized protocol Receives: Other: Community Nurse Case Manager (CNCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of daily living
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
Measured: 0,1,3,6,12 months
Cognitive performance
Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). A score of 26 or higher is considered normal
Measured: 0,3,6,12 months
Health-related quality of life
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.
Measured: 0,3,6,12 months
Secondary outcomes (16)
Frailty
Evaluated 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
Measured: 0,1,3,6,12 months
Primary caregiver overload
Evaluated by the Zarit scale. Score (22 - 110). A score ≥47 points being considered overburden
Measured: 0,3,6,12 months
Therapeutic adherence
Evaluated 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.
Measured: 1,3,6,12 months
User satisfaction
Evaluated 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
Measured: 1,3,6,12 months
Degree of dyspnoea
Evaluated by modified Medical Research Council Scale. This consists of 5 levels. The higher the level, the lower the tolerance to activity due to dyspnoea
Measured: 0,1,3,6,12 months
Symptoms attributable to heart disease
Evaluated 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
Measured: 0,1,3,6,12 months
Number of hospital admissions
Collected from the patient's medical history
Measured: 1,3,6,12 months
Number of drugs chronically prescribed
Collected from the patient's medical history
Measured: 0,1,3,6,12 months
Weight
Collected from the patient's medical history
Measured: 0 months
Height
Collected from the patient's medical history
Measured: 0 months
Body mass index
Collected from the patient's medical history
Measured: 0 months
Blood pressure systolic and diastolic
Measured in mmHg
Measured: 0,1,3,6,12 months
Oxygen saturation
Measured in %
Measured: 0,1,3,6,12 months
Heart rate
Measured in bpm
Measured: 0,1,3,6,12 months
Capillary blood glucose
Measured in mg/dl
Measured: 0,1,3,6,12 months
Capillary glycosylated haemoglobin
Measured in %
Measured: 0,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex and Chronic PluripathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- José Ignacio Recio Rodriguez
- Sponsor type
- University, hospital or other
- Collaborators
- Consejo General de Colegios Oficiales de Enfermería de España, Instituto Español de Investigación Enfermera, Gerencia Regional de Salud de Castilla y Leon
- Responsible party
- Sponsor-investigator, José Ignacio Recio Rodriguez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155591
- Sponsor's protocol ID
- GRS 2490/B/22
- Acronym
- ENGESCC
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iglesias-Sierra V, Sanchez-Aguadero N, Recio-Rodriguez JI, Sanchez-Salgado B, Garcia-Ortiz L, Alonso-Dominguez R. Effectiveness of the Community Nurse Case Manager in Primary Care for Complex, Pluripathological, Chronic, Dependent Patients: A Study Protocol. Nurs Rep. 2025 May 29;15(6):191. doi: 10.3390/nursrep15060191.
PubMed 40559482
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Community Nurse Case Manager in Primary Care for Complex and Pluripathological Chronic Dependent Patients: Study Protocol
- ClinicalTrials.gov ID
- NCT06155591
- Acronym / sponsor ID
- ENGESCC / GRS 2490/B/22
- Conditions
- Complex and Chronic Pluripathology
- Keywords
- Multimorbidity, Functional Dependence, Case Management, Primary Health Care, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- José Ignacio Recio RodriguezUniversity, hospital or other
- Collaborators
- Consejo General de Colegios Oficiales de Enfermería de España, Instituto Español de Investigación Enfermera, Gerencia Regional de Salud de Castilla y Leon
- Study start
- Jan 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Usual care of complex and pluripathological chronic patients (CPCP) |
| Experimental Group | Experimental | Other: Community Nurse Case Manager (CNCM)Usual care of CPCP + Community Nurse Case Manager (CNCM) standardized protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community 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. | Other | Experimental Group |
Primary outcome
Activities of daily living
Time frame: 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
Time frame: 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
Time frame: 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.
16 secondary outcomes
Frailty
Time frame: 0,1,3,6,12 months
Primary caregiver overload
Time frame: 0,3,6,12 months
Therapeutic adherence
Time frame: 1,3,6,12 months
User satisfaction
Time frame: 1,3,6,12 months
Degree of dyspnoea
Time frame: 0,1,3,6,12 months
Symptoms attributable to heart disease
Time frame: 0,1,3,6,12 months
Number of hospital admissions
Time frame: 1,3,6,12 months
Number of drugs chronically prescribed
Time frame: 0,1,3,6,12 months
Weight
Time frame: 0 months
Height
Time frame: 0 months
Body mass index
Time frame: 0 months
Blood pressure systolic and diastolic
Time frame: 0,1,3,6,12 months
Oxygen saturation
Time frame: 0,1,3,6,12 months
Heart rate
Time frame: 0,1,3,6,12 months
Capillary blood glucose
Time frame: 0,1,3,6,12 months
Capillary glycosylated haemoglobin
Time frame: 0,3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 40559482Iglesias-Sierra V, Sanchez-Aguadero N, Recio-Rodriguez JI, Sanchez-Salgado B, Garcia-Ortiz L, Alonso-Dominguez R. Effectiveness of the Community Nurse Case Manager in Primary Care for Complex, Pluripathological, Chronic, Dependent Patients: A Study Protocol. Nurs Rep. 2025 May 29;15(6):191. doi: 10.3390/nursrep15060191.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Community Nurse Case Manager (CNCM) in people with Complex and Chronic Pluripathology, run by José Ignacio Recio Rodriguez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia Iglesias Sierra (630098762, viglesiass@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of daily living (time frame: 0,1,3,6,12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.