NCT07099508

Brief Summary

This pilot study investigates the feasibility of a prospective longitudinal observational approach to identify variables influencing home nursing care time. Conducted within the ULSS 6 Euganea health district in Italy, the study will analyze nursing care and travel time across approximately 350 home visits involving up to 200 voluntarily enrolled adult patients. Data will be collected anonymously by nurses using a digital tool (REDCap), capturing a predefined core set of variables previously selected via the Delphi method. The study aims to understand the association between individual, contextual, and organizational variables and the time required for home nursing interventions. Results will inform better planning and resource allocation for home care services.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

Same day

First QC Date

July 18, 2025

Last Update Submit

July 25, 2025

Conditions

Keywords

Home Nursing CareNursing time measurementTravel timeHealth planning

Outcome Measures

Primary Outcomes (1)

  • Factors thath influence home care nurses

    Measure the factors that influence the work of home care nurses in individual subjects and different territorial contexts in relation to care time. * patient's socioeconomic status (age, level of education, understanding of italian language, rural or urban context,..) * patient's clinical status (hospitalizations, type of assistance needed, type of support, diagnosis, mobility status..) * caregiver (type, hours of formal and informal caregiving, coping, knowledge of the patient's medical history,..) * visit specific variables (presence of animals, number of services provided, time required for the service in minutes,..) * IDC-PAL items

    From the enrollment to the end of the study at two months

Secondary Outcomes (1)

  • Time and space spent by the nurse traveling to the patient's home

    From the enrollment to the end at two months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving home care nursing services: * Condition of frailty or dependence: often associated with chronic or degenerative diseases. * Presence or absence of family support network: the lack of caregivers can increase the required frequency of visits. * Multimorbidity: patients often suffer from multiple chronic conditions (e.g., diabetes, heart failure, COPD, dementia). * Disabilities or functional limitations: motor, sensory, or cognitive impairments that necessitate home-based care. * Ongoing or complex healthcare needs: including advanced wound care, stoma management, enteral/parenteral nutrition, intravenous therapy. * End-of-life or palliative care: some patients receive home palliative care (e.g., type III Integrated Home Care).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Matteo Martinato, MSc, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 1, 2025

Study Start

September 1, 2025

Primary Completion

September 1, 2025

Study Completion

November 1, 2025

Last Updated

August 1, 2025

Record last verified: 2025-07