NCT02214017

Brief Summary

Progress in technology has made telemedicine-based solutions with video consultations available in the management and treatment of chronic diseases like diabetes, heart failure and lung insufficiency at home. However, no direct comparisons on health outcomes of telemedicine using video consultations versus usual outpatient treatment are available. We wanted to implement a model of telemedicine and to evaluate health indicators in type 2 diabetes patients treated by video consultations or the standard outpatient treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable type-2-diabetes-mellitus

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, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

November 19, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

August 11, 2014

Results QC Date

August 21, 2017

Last Update Submit

November 15, 2018

Conditions

Keywords

diabetestelemedicineglycemialipidsblood pressure

Outcome Measures

Primary Outcomes (1)

  • Glycemia

    Percent of glycosylated hemoglobin, HbA1c

    Six months of treatment

Secondary Outcomes (1)

  • Lipids

    Six months of treatment

Other Outcomes (1)

  • Blood Pressure

    Six months of treatment

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Diabetic patients attended usual procedure in the outpatient clinic with regular visits

Behavioral: Behavioral motivation

Telemedicine group

EXPERIMENTAL

After initial check-up in the outpatient dept. medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group. A videotelephone, TandBerg E20, in the telemedicine group was delivered and serviced by the Danish Tele Company, TDC.

Device: A videotelephone, TandBerg E20,Behavioral: Behavioral motivation

Interventions

Telemedicine group

Optimization of medical care in diabetes

Standard careTelemedicine group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participants had to live at home, be able to communicate by videotelephone, had no psychiatric disorders, an age between 40 and 85 years and be able to administer medication. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endrinology Dept, Kolding Hospital

Kolding, 6000, Denmark

Location

Related Publications (5)

  • Bower P, Cartwright M, Hirani SP, Barlow J, Hendy J, Knapp M, Henderson C, Rogers A, Sanders C, Bardsley M, Steventon A, Fitzpatrick R, Doll H, Newman S. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial. BMC Health Serv Res. 2011 Aug 5;11:184. doi: 10.1186/1472-6963-11-184.

    PMID: 21819569BACKGROUND
  • 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
  • Stone RA, Rao RH, Sevick MA, Cheng C, Hough LJ, Macpherson DS, Franko CM, Anglin RA, Obrosky DS, Derubertis FR. Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial. Diabetes Care. 2010 Mar;33(3):478-84. doi: 10.2337/dc09-1012. Epub 2009 Dec 15.

    PMID: 20009091BACKGROUND
  • Wootton R. Twenty years of telemedicine in chronic disease management--an evidence synthesis. J Telemed Telecare. 2012 Jun;18(4):211-20. doi: 10.1258/jtt.2012.120219.

    PMID: 22674020BACKGROUND
  • Rasmussen OW, Lauszus FF, Loekke M. Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic. J Telemed Telecare. 2016 Sep;22(6):363-8. doi: 10.1177/1357633X15608984. Epub 2015 Oct 14.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Information Motivation Behavioral Skills Model

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Models, PsychologicalModels, TheoreticalInvestigative Techniques

Results Point of Contact

Title
Finn Lauszus
Organization
Herning Hospital

Study Officials

  • Ole W Rasmussen, Dr.Med.Scie

    Kolding Sygehus

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, Associate Professor

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 12, 2014

Study Start

October 1, 2011

Primary Completion

July 1, 2012

Study Completion

October 1, 2012

Last Updated

November 19, 2018

Results First Posted

November 19, 2018

Record last verified: 2018-11

Locations