NCT03730285

Brief Summary

Evaluation of discharge after arrival at emergency unit, Kolding Hospital combined with treatment and rehabilitation in the home either by telemedicine or the usual treatment

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Status
unknown

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

First Submitted

Initial submission to the registry

February 28, 2016

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

February 28, 2016

Last Update Submit

November 1, 2018

Conditions

Emergencies

Keywords

telemedicine, patient satisfaction, randomization

Outcome Measures

Primary Outcomes (1)

  • Walking distance

    Measurement of walking distance regularly by home care nurse (in meters)

    3 months

Secondary Outcomes (2)

  • Days of admittance

    3 months

  • Fall in home

    3 months

Study Arms (2)

Telemedicine

ACTIVE COMPARATOR

Discharge with telemedicine contact to emergency nurse, doctor, and municipality

Device: Telemedicine

Control

NO INTERVENTION

Standard care with 24-48 h observation at emergency unit

Interventions

TelemedicineDEVICE

Installation of videotelephone with broadband in patient's home

Telemedicine

Eligibility Criteria

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

You may qualify if:

  • municipal home care at admittance
  • admitted to medical emergency care unit at Kolding Hospital

You may not qualify if:

  • ketoacidosis,
  • hyperosmolar diabetic coma,
  • serious hypercalcemia,
  • acute renal insufficiency with serum-creatinin \> 175 mmol/l,
  • serious cardiac failure
  • septicemia
  • acute coronary disease
  • apoplexia cerebri
  • neuroinfection
  • progressive or active cancer
  • hepatic disease
  • serious psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • van Mastrigt GA, Joore MA, Nieman FH, Severens JL, Maessen JG. Health-related quality of life after fast-track treatment results from a randomized controlled clinical equivalence trial. Qual Life Res. 2010 Jun;19(5):631-42. doi: 10.1007/s11136-010-9625-5. Epub 2010 Mar 26.

    PMID: 20340049BACKGROUND

  • Shea S, Weinstock RS, Teresi JA, Palmas W, Starren J, Cimino JJ, Lai AM, Field L, Morin PC, Goland R, Izquierdo RE, Ebner S, Silver S, Petkova E, Kong J, Eimicke JP; IDEATel Consortium. A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study. J Am Med Inform Assoc. 2009 Jul-Aug;16(4):446-56. doi: 10.1197/jamia.M3157. Epub 2009 Apr 23.

    PMID: 19390093BACKGROUND

  • Mayes PA, Silvers A, Prendergast JJ. New direction for enhancing quality in diabetes care: utilizing telecommunications and paraprofessional outreach workers backed by an expert medical team. Telemed J E Health. 2010 Apr;16(3):358-63. doi: 10.1089/tmj.2009.0110.

    PMID: 20406123BACKGROUND

MeSH Terms

Conditions

EmergenciesPatient Satisfaction

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Ole W Rasmussen, DrMedScie

    Kolding Sygehs, Medical Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole W Rasmussen, Dr Med Scie

CONTACT

004576362000Ole.Winther.Rasmussen@rsyd.dk

Finn F Lauszus, PhD

CONTACT

004578430999finlau@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

February 28, 2016

First Posted

November 5, 2018

Study Start

November 1, 2019

Primary Completion

January 1, 2021

Study Completion

April 1, 2021

Last Updated

November 5, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

publication planned