DEscripitive Patient Analysis to Enable Risk-based Qualit... | NCT06178302

Studies
DEscripitive Patient Analysis to Enable Risk-based Quality Improvement Measures in a lArge iNternal mediCIne grouP Practice

NCT06178302

Sponsor

Imed19

Status

Not yet recruiting

Last Update Posted

May 7, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Liver Dysfunction
Thyroid
Atherosclerosis
Heart Failure
Intestinal Disease
Heart Diseases

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2025Estimated

Primary Completion Date

Dec 2034Estimated

Completion Date

Jun 2035Estimated

First Submitted Date

Dec 3, 2023

First Submission Date that Met QC Criteria

Dec 11, 2023

First Posted Date

Dec 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2025

Last Update Posted Date

May 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background: Clinical trials often include patients from large hospitals or university clinics. Information on patients cared for at offices from statutory health insurance-accredited physicians represent evidence gaps.

Aims/Objectives:

The present study has three aims: First, to systematically describe the patient population of a large group practice for internal medicine. Second, to identify high-risk patients using established risk scores. And third, to include routine imaging data to optimize patient management.

Methods/Facility Enrolling Participants: This is a prospective, observational study assessing patients' baseline characteristics, risk evaluation and integrating data from imaging test. The setting of the present study is a large group practice for internal medicine which consists of statutory health insurance-accredited physicians. Study participants will be included during daily routine, real-world clinical care and therefore represent all-comers fulfilling the inclusion criteria:

Female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (TSH) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules.
Routine laboratory results available within the last 3 months.
Available imaging data within the last 3 months performed on site. Perspective: The study is designed to evaluate the current situation and quality of health care in defined patient populations in the routine clinical setting of a large-scale public office. These data will provide a profound rationale to identify quality issues and limitations in our performance of guideline-conform treatment in routine patient care.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Baseline characteristics	To describe the baseline characteristics (age, weight, height, routinely assesses laboratory parameters such as creatinin, thyroid hormones, liver enzymes, lipids) of patients with heart failure in a community based internal medicine practice.	Baseline/time of study inclusion
Risk evaluation	Describe risk according to risk scores (the CHADS-VASC Score, the EU- TIRADS score, the ASCVD risk score, FIB-4 Score )	At baseline and as available during routine clinical follow-up, up to 10 years (no formal follow-up visits/time frames))
Quality of care evaluation	Describe achievement of individual treatment targets according to current guidelines (Lipid targets, bloodpressure targets)	At baseline and as available during routine clinical follow-up, up to 10 years (no formal follow-up visits/time frames)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (TSH) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules.
Routine laboratory results available within the last 3 months.
Available imaging data within the last 3 months performed on site.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient population of a large group practice for internal medicine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christopher Adlbrecht, MD	Contact	+4313671373		ordination@imed19-privat.at

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases
D013959	Thyroid Diseases
D050197	Atherosclerosis
D006333	Heart Failure
D007410	Intestinal Diseases
D006331	Heart Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D004700	Endocrine System Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

Browse Leaves

Not provided

Browse Branches

Not provided