NCT05574790

Brief Summary

A prospective qualitative quantitative study was designed to create predictive models of readmission in multimorbid patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

October 7, 2022

Last Update Submit

September 21, 2023

Conditions

Keywords

multimorbid PatientsReadmissionMortalityPredictive

Outcome Measures

Primary Outcomes (2)

  • Readmission

    number of readmissions in the early period (transition to discharge, 1 month

    1 month

  • Readmission

    number of readmissions in the annual period

    1 year

Study Arms (1)

Admitted

We will include patients who had been admitted by meeting Ollero et al categories in hospitalization ward

Other: annual follow up

Interventions

Collection of the following information during the year following discharge from the initial episode (initial cohort): readmissions, dates and causes of readmission, mortality

Admitted

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

multimorbid patients who are equivalently complex and with high risk for destabilization, difficult to manage and with mutual interrelationships.

You may qualify if:

  • Patients over 18 years of age
  • Patients discharged from the Internal Medicine departments of the participating centers due to acute pathology, de novo or decompensation of a chronic pathology who also present at least 2 of the cathegories of Ollero et al.

You may not qualify if:

  • Patients admitted for end-of-life treatment, scheduled admissions, exacerbation of rheumatic pathology or systemic disease, study of anaemia in patients with no-known comorbidity, search for neoplasia and acute processes without associated comorbidity. -
  • Failure to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Galdakao Usansolo

Galdakao, Bizkaia, 48960, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Study Officials

  • Susana García Gutiérrez, PhD

    Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 12, 2022

Study Start

February 7, 2022

Primary Completion

June 30, 2022

Study Completion

August 30, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations