Chronic Diseases in Primary Care

NCT07479810 | Enrolling By Invitation

• 1 other identifier: Prog. 334CET
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This quasi-experimental study aims to assess if a nurse-led proactive intervention can enhance self-care and reduce hospitalizations or accesses to emergency department visits in chronically ill adults over 65 years old. The questions that it seeks to answer are the following:

1. 1.Can a structured, proactive nurse-led intervention reduce hospitalizations and access to emergency departments?
2. 2.Can this intervention improve self-care, medication adherence, and the overall quality of life?

Conditions

Chronic Disease

Keywords

primary care; community nursing; chronic deseases; patient education

Outcome Measures

Primary Outcomes (1)

• Composite Outcome - access to the emergency department or hospitalization

  The number of patients with at least one event between: * access to the emergency department for pathological causes related to the chronic disease; * hospitalization for related pathological causes. Data will be collected from hospital integrated databases (Atlante, HR suite) from authorized employed healthcare professionals.

  6 and 12 months pre-post

Secondary Outcomes (3)

• Result endpoint: Medication adherence.

  6 and 12 months after the intervention

• Result endpoint: Self-care ability

  6 and 12 months after the intervention

• Result endpoint: Quality of received care

  6 and 12 months after the intervention

Other Outcomes (8)

• Process evaluations: periodic use of nursing service

  12 months after the intervention

• Process evaluation: service utilization for each user

  12 months after the intervention

• Process evaluations: GP visits

  12 months after the intervention

Study Arms (1)

Intervention

OTHER

Single arm

Other: Proactive Intervention

Interventions

Proactive Intervention OTHER

The educational program will be carried out as a structured intervention, aiming to actively involve patients in their own healthcare pathway, promoting changes in behavior and self-care. The first act will consist of a double-level assessment, first having nurses collect data to assess the educational needs, then delving into a structured assessment of social and educational needs from lifestyle, self-care, medication adherence, and frailty risk. After that, four communication approaches will be implemented to enhance educational effectiveness: teach-back, motivational interviewing, the SHERPA model, and Calgary Family Interviews.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosed with at least one non-oncological chronic condition;
• Aged over 65 years;
• Assigned to general practitioners in the district of reference of the Community Health Home.

You may not qualify if:

• Life expectancy of less than 12 months, as assessed by the general practitioner;
• Having more than one home access a week of intensive home care.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Casa della Comunità di Lonigo

Lonigo, Vicenza, Italy

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The intervention will involve family and community nurses proactively caring for patients with chronic conditions cared for at the Community Health Home located in a rural district in northern Italy. This proactive approach will be initiated through a phone call, during which the service will be introduced, and an appointment will be scheduled for either an outpatient or home nursing visit, depending on the patient's ability to access the Community Health Home. Following the initial structured assessment interview, patients will receive structured follow-up care with at least three contacts over six months. The frequency of these contacts will be increased at the nurse's discretion in cases of poor self-care ability or multiple educational needs identified during the initial interview. The follow-up will consist of in-person visits alternated with telephone follow-ups, focusing on self-care skill development and clinical monitoring.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: March 18, 2026
• Study Start: November 1, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)