EmergenciesNCT03730285
Fast-track Discharge With Telemedicine
A study testing Telemedicine in people with Emergencies, run by Kolding Sygehus.
Trial 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 Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Emergencies
- What is being tested?
- Telemedicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- municipal home care at admittance
- admitted to medical emergency care unit at Kolding Hospital
Who cannot join
- ketoacidosis,
- hyperosmolar diabetic coma,
- serious hypercalcemia,
- acute renal insufficiency with serum-creatinin > 175 mmol/l,
- serious cardiac failure
- septicemia
Show all 12Show fewer
- acute coronary disease
- apoplexia cerebri
- neuroinfection
- progressive or active cancer
- hepatic disease
- serious psychiatric disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fast-track Discharge Combined With Treatment and Rehabilitation at Home With Telemedicine
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
Read the detailed description
Participants are acute in-patients at the Medical Department, Kolding Hospital. Participants shall be informed about the project, and all screened initially within 30 minutes. After 3-4 hours adjusted treatment and possible need for new investigations are conducted. Patients are randomized at discharge to home treatment with rounds via telemedicine with support of emergency team of nurses or hospitalization in emergency unit. Observations, treatment and rehabilitation follow the same standards and guidelines for all patients. The cohort of patients is recruited between Oct 1, 2015 until January 1, 2016. The study is a randomized quality evaluation study of patient satisfaction, of the emergency team at Kolding Municipality, re-admittance rate, use of other health services, and new services from the municipality.
- Conditions
- Emergencies
- Being tested
- Telemedicine
- Keywords
- telemedicine, patient satisfaction, randomization
- Medical subject headings
- Emergencies, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineDevice
Installation of videotelephone with broadband in patient's home
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Active comparator | Discharge with telemedicine contact to emergency nurse, doctor, and municipality Receives: Device: Telemedicine |
| Control | No intervention | Standard care with 24-48 h observation at emergency unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance
Measurement of walking distance regularly by home care nurse (in meters)
Measured: 3 months
Secondary outcomes (2)
Days of admittance
Days in hospital according t hospital charts
Measured: 3 months
Fall in home
No. of falls in home recorded by home care nurse
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study startNov 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Winther Rasmussen, Kolding Sygehus
- Investigators
- Ole W Rasmussen, DrMedScie, Principal investigator, Kolding Sygehs, Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730285
- Sponsor's protocol ID
- Fast-track telemedicine
- Status last verified
- Nov 2018
- First submitted
- 28 Feb 2016
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publication planned
Publications
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.
PubMed 20340049Shea 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.
PubMed 19390093Mayes 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.
PubMed 20406123
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track Discharge Combined With Treatment and Rehabilitation at Home With Telemedicine
- ClinicalTrials.gov ID
- NCT03730285
- Acronym / sponsor ID
- Fast-track telemedicine
- Conditions
- Emergencies
- Keywords
- telemedicine, patient satisfaction, randomization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Participants are acute in-patients at the Medical Department, Kolding Hospital. Participants shall be informed about the project, and all screened initially within 30 minutes. After 3-4 hours adjusted treatment and possible need for new investigations are conducted. Patients are randomized at discharge to home treatment with rounds via telemedicine with support of emergency team of nurses or hospitalization in emergency unit. Observations, treatment and rehabilitation follow the same standards and guidelines for all patients. The cohort of patients is recruited between Oct 1, 2015 until January 1, 2016. The study is a randomized quality evaluation study of patient satisfaction, of the emergency team at Kolding Municipality, re-admittance rate, use of other health services, and new services from the municipality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Active comparator | Device: TelemedicineDischarge with telemedicine contact to emergency nurse, doctor, and municipality |
| Control | No intervention | –Standard care with 24-48 h observation at emergency unit |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- municipal home care at admittance
- admitted to medical emergency care unit at Kolding Hospital
Key exclusion criteria (12 listed)
- ketoacidosis,
- hyperosmolar diabetic coma,
- serious hypercalcemia,
- acute renal insufficiency with serum-creatinin > 175 mmol/l,
- serious cardiac failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineInstallation of videotelephone with broadband in patient's home | Device | Telemedicine |
Primary outcome
Walking distance
Time frame: 3 months
Measurement of walking distance regularly by home care nurse (in meters)
2 secondary outcomes
Days of admittance
Time frame: 3 months
Fall in home
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Background: PubMed 20340049van 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.
- Background: PubMed 19390093Shea 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.
- Background: PubMed 20406123Mayes 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.
- Individual participant dataSharing planned: Yes. publication planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole W Rasmussen, DrMedScie principal investigator
Kolding Sygehs, Medical Department
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Emergencies, run by Kolding Sygehus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ole W Rasmussen, Dr Med Scie (004576362000, Ole.Winther.Rasmussen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730285, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2018.