NCT02928939

Brief Summary

Clinical practice guidelines do not take into account multimorbidity and various potential therapeutic conflicts. Identifying and quantifying therapeutic conflicts is crucial in multimorbid patients having more than two acute or chronic diseases. Guidance should be available for frequent encountered situations, e.g. gastrointestinal bleeding or exacerbation of diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,101

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

October 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

3.8 years

First QC Date

October 6, 2016

Last Update Submit

April 7, 2021

Conditions

Gastrointestinal HemorrhageDiabetes ComplicationsMultimorbidity

Keywords

multimorbiditymultiple chronic conditionsdrug-drug interactionsdrug-disease interactionspolypharmacyOral anticoagulantsSteroids

Outcome Measures

Primary Outcomes (2)

  • Patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs

    Do anticoagulants or antiplatelet drugs increase the risk of repeated bleeding in patients with gastrointestinal bleeding?

    5 years

  • Patients with diabetes mellitus and systemic corticosteroids

    Do systemic corticosteroids increase the risk of exacerbation in patients with diabetes mellitus?

    5 years

Study Arms (1)

Multimorbid patients

Other: drug-drug or drug-disease interaction

Interventions

drug-drug or drug-disease interactionOTHER
Multimorbid patients

Eligibility Criteria

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

We investigate in the field of multimorbidity in a tertiary hospital regarding therapeutic conflicts of GI bleeding and diabetes exacerbation.

You may qualify if:

  • Inpatients at the University Hospital Zurich, USZ
  • Male and female patients, aged 18 years or older
  • Fulfilling the criteria for Use Case A or B (i.e. patients with gastrointestinal bleeding and anticoagulants or antiplatelet drugs, Use Case A or patients with diabetes mellitus and/or systemic corticosteroids, Use Case B)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageDiabetes ComplicationsMultiple Chronic Conditions

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusEndocrine System DiseasesChronic DiseaseDisease Attributes

Study Officials

  • Edouard Battegay, Prof. MD

    University Hospital Zurich, Department of Internal Medicine

    STUDY DIRECTOR

  • Klarissa Siebenhüner, MD

    University Hospital Zurich, Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

  • Patrick Beeler, MD

    University Hospital Zurich, Department of Internal Medicine

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 10, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2020

Study Completion

April 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

CH(1)