NCT03513159

Brief Summary

The aim of the transsectoral care project TIGER is the reduction of readmission rates of geriatric patients. This aim shall be achieved by improving the hitherto inadequate care process for geriatric patients in the transition from hospital to home. The program offers substantial support of patients and their informal caregivers in the transition process from hospital to home via so called pathfinders, specialized nurses in geriatrics.The pathfinders effectively intertwine stationary and ambulatory care teams caring for a patient, thereby augmenting and complementing effective hospital release management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

April 17, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

April 17, 2018

Last Update Submit

March 2, 2021

Conditions

Keywords

transitional care, geriatric, readmission,dischargequality of life

Outcome Measures

Primary Outcomes (1)

  • Readmission Rate

    The number of readmissions of a patient into a hospital within up to 15 months (study period for the patient.plus 3 months prior to enrollment).

    up to 12 months

Secondary Outcomes (14)

  • Functionality and mobility - 1

    up to 12 months

  • Functionality and mobility - 2

    up to 12 months

  • Functionality and mobility - 3

    up to 12 months

  • Functionality and mobility - 4

    up to 12 months

  • Functionality and mobility - 5

    up to 12 months

  • +9 more secondary outcomes

Study Arms (2)

Pathfinder support

EXPERIMENTAL

Pathfinder support with development of an individual care plan for the intervention patients and their informal caregivers, with the hospital physicians already inside the hospital setting. This will then be developed and improved further during up to twelve months after hospital release with the primary physician. The pathfinders will coordinate the ambulatory care team services and closely involve the primary physicians. The patients and their informal caregivers will be empowered and educated to achieve a stabilization or improvement in functionality, independence, quality of life, coping with disease, nutritional status and wound healing process. In the regular assessments they will be tested for functionality and nutritional parameters, quality of life and stress scores.

Behavioral: Pathfinder support

Control without pathfinder support

NO INTERVENTION

Control patients will not be supported by pathfinders. In regular assessments they will be tested for functionality and nutritional parameters, quality of life and stress scores.

Interventions

A pathfinder will support the patient with structured activities.

Pathfinder support

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • will go back home after Hospital stay, AOK Patient, MiniMentalStateExamination MMSE score of at least 22, is living within 50 km range of the hospital

You may not qualify if:

  • palliative status, planned readmission into hospital within next 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the Order of St.John of God Regensburg

Regensburg, Bavaria, 93049, Germany

Location

Institute for Biomedicine of Aging, University of Erlangen-Nürnberg

Nuremberg, 90408, Germany

Location

Related Publications (2)

  • Gehr TJ, Freiberger E, Sieber CC, Engel SA. A typology of caregiving spouses of geriatric patients without dementia: caring, worried, desperate. BMC Geriatr. 2021 Sep 6;21(1):483. doi: 10.1186/s12877-021-02425-1.

  • Rimmele M, Wirth J, Britting S, Gehr T, Hermann M, van den Heuvel D, Kestler A, Koch T, Schoeffski O, Volkert D, Wingenfeld K, Wurm S, Freiberger E, Sieber C; TIGER consortium. Improvement of transitional care from hospital to home for older patients, the TIGER study: protocol of a randomised controlled trial. BMJ Open. 2021 Feb 8;11(2):e037999. doi: 10.1136/bmjopen-2020-037999.

Study Officials

  • Cornel Sieber, Prof. Dr.

    Institute for Biomedicine of Aging

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The patients data will be anonymized and entered into an electronic Case Report form. The Outcomes Assessor will only see the anonymized data.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The Intervention Group will be supported by the activities of the pathfinder, the Control Group will not. Both Groups will be tested for functional and nutritional Status and for Quality of life and stress scores.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 1, 2018

Study Start

April 25, 2018

Primary Completion

June 30, 2020

Study Completion

February 28, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

The final anonymized trial data set will be available to the TIGER consortium. After completion of evaluation and dissemination by the TIGER-consortium, the goal is that an anonymized data set will be made available to interested Researchers upon reasonable request, being deposited in a repository of the University. During finalization of the study a detailed data sharing plan will be developed and introduced into this trial registry.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
The repository of the data set is under construction with the University.
Access Criteria
Anonymized data set will be available to interested Researchers upon reasonable request

Locations