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Telemedicine Strategy With Home Treatment Save Resources

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
A videotelephone, TandBerg E20,
Behavioral motivation
Sponsored by
Kolding Sygehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring diabetes, telemedicine, glycemia, lipids, blood pressure

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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. -

Exclusion Criteria:

Exclusion criteria were type 1 diabetes, speech disabilities, non-Danish speakers or with severe chronic disease like renal failure (GFR<30 ml/min), liver insufficiency or in cancer treatment.

-

Sites / Locations

  • Endrinology Dept, Kolding Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Telemedicine group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Glycemia
Percent of glycosylated hemoglobin, HbA1c

Secondary Outcome Measures

Lipids
Total-cholesterol

Full Information

First Posted
August 11, 2014
Last Updated
November 15, 2018
Sponsor
Kolding Sygehus
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1. Study Identification

Unique Protocol Identification Number
NCT02214017
Brief Title
Telemedicine Strategy With Home Treatment Save Resources
Official Title
Can a Telemedicine Strategy With Home Treatment Save Resources in Acute Medical Conditions While Maintaining Quality of Care?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kolding Sygehus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Chronic illnesses, such as asthma, diabetes, heart failure, and hypertension, represent a significant burden of disease Chronic diseases also impose huge costs on the health care systems responsible for managing them as well as their significance for those affected. Non-pharmacological treatment is mandatory for type 2 diabetes patients characterized by central obesity, sedentary lifestyle, and overeating (1). Secondary failure to reach treatment goals despite an extensive National diabetes rehabilitation program in Denmark is often seen (2). Outpatient control shows positive effects on outpatient rehabilitation (3) reducing HbA1c, weight, and blood pressure. However, some patients never accomplish good diabetes regulation and in others regulation deteriorates over time. New approaches are required and need testing to motivate and give feedback to the patients at home. Telemedicine has the capacity to achieve this, where a diabetic nurse may optimize motivation, treatment, and diet through direct feedback adapted to milieu of the patient in accordance with a potential spouse. Good metabolic control is important as diabetes is inevitable a factor for increased risk of cardiovascular disease, neuropathy, and nephropathy (4). The quality of life and reduction in work ability is affected, thus, life expectancy is shortened by 6-8 years. Multi-factorial intervention may delay this (5). The high incidence of the serious implications strengthens the importance of achieving good metabolic control through lifestyle changes. Health education shows reduction in cardiovascular risk factors (6-8), which often disappears after the end of the intervention (6-8). Good self-care and compliance improve the outcome and reduces diabetes complications (9) and we need new tools to achieve higher attendance to the National diabetes program. Telemedicine represents a novel tool of educating and controlling chronic diseases. It reduced HbA1c for five years with in trials designed to test video-conferencing, clinical data entry and review, web-based education materials, and monitored chat groups (10). Home telemonitoring was compared with telephone calls reducing the HbA1c levels in type 2 diabetes (11) and the technology confer a statistically significant reduction in HbA1c of 0.5 % when applied as add-on to standard treatment. It was used adjunctively to a broader telemedicine initiative for adults with diabetes. The largest telemedicine study initiated by the Ministry of Health in England (Whole Systems Demonstrator) randomized 3320 patients [12] with heart failure and diabetes to telemedicine care. It showed that the telemedicine intervention as add-on therapy resulted a statistically significant reduction in mortality from 8.3% versus 4.6%. Similarly, it showed a reduction of number of inpatients and the number of bed days by 11% and 14%, respectively. The patients' health-related quality of life was unchanged. The savings was less than the additional cost of using telemedicine and overall it cost 15% more per patient. This point at two important factors when applying telemedicine solutions: First, it should preferably replace the standard care and not add-on and, second, be based on the patient's own computer, tablet or smartphone, all of which will reduce the cost substantially. Telemedicine is available for 98-99% of all inhabitants in Denmark by broadband, which allows video conference at home. A few randomized trials with this technology are available at present. We aimed at implementing a telemedicine model in our setting and the design and method should evaluate the quality of treatment as well as technical problems and replace the standard treatment. Aim: We compared clinical data from a telemedicine group with a standard care group treated by the same medical algorithm. We wanted to reduce the barriers for the use of a home monitoring and -treatment among elderly, type 2 diabetes patients Hypothesis: Treatment by telemedicine or standard care in type 2 diabetes patients results in similar clinical HbA1c, blood pressure, and lipids. Materials and methods: Individually visits at the outpatient clinic to plan improvement of glycemic control were made before information of the study was given. Individual goals of the treatment and the drugs needed to fulfil the objectives were agreed on. The patients received the information for the study, and if they wanted to participate, they signed an approval of participation and randomization was performed. All medical treatment, control of blood glucose, blood pressure, lipids, and education was executed via videotelephone in the telemedicine group In the control group patients attended usual procedure in the outpatient clinic with regular visits. Summary of recommendations for glycemic, blood pressure, and lipid control for the participants were: HbA1c 6.5-7.5% (48-58 mmol/L) , fasting blood glucose 6.5-7.5 mmol/l, diurnal blood pressure < 130/80 mmHg, LDL-cholesterol <100 mg/dL (<2.5 mmol/L) and start of medication with elevated urinary albumin/creatinine excretion ≥30 (μg/mg). The treatment algorithm was lifestyle adjustment plus antidiabetic drugs described elsewhere. When the goals were reached within 3 weeks, the videotelephone was disconnected and patients were encouraged to continue glycemic control at their general practitioner. However, the trial went on with a follow-up and evaluation after six month according to the 'intention-to-treat' principle to see if a difference in the initial care mattered significantly. A videotelephone in the telemedicine group was delivered and serviced by the Danish Tele Company. The trial included type 2 diabetes patients allocated from October 2011 until July 2012 referred to the outpatient clinic from general practitioners. At entry, all patients were screened by albumin/creatinine excretion rate, blood pressure, and electrocardiogram, lipid profile, diabetic food control, and arteriosclerotic symptoms (angina pectoris, claudication, and fatigue). Diurnal blood pressure was measured by monitors. All measurements were repeated six months after inclusion in all participants

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, telemedicine, glycemia, lipids, blood pressure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Diabetic patients attended usual procedure in the outpatient clinic with regular visits
Arm Title
Telemedicine group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
A videotelephone, TandBerg E20,
Intervention Type
Behavioral
Intervention Name(s)
Behavioral motivation
Intervention Description
Optimization of medical care in diabetes
Primary Outcome Measure Information:
Title
Glycemia
Description
Percent of glycosylated hemoglobin, HbA1c
Time Frame
Six months of treatment
Secondary Outcome Measure Information:
Title
Lipids
Description
Total-cholesterol
Time Frame
Six months of treatment
Other Pre-specified Outcome Measures:
Title
Blood Pressure
Description
Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207
Time Frame
Six months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. - Exclusion Criteria: Exclusion criteria were type 1 diabetes, speech disabilities, non-Danish speakers or with severe chronic disease like renal failure (GFR<30 ml/min), liver insufficiency or in cancer treatment. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole W Rasmussen, Dr.Med.Scie
Organizational Affiliation
Kolding Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endrinology Dept, Kolding Hospital
City
Kolding
ZIP/Postal Code
6000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21819569
Citation
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.
Results Reference
background
PubMed Identifier
19390093
Citation
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.
Results Reference
background
PubMed Identifier
20009091
Citation
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.
Results Reference
background
PubMed Identifier
22674020
Citation
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.
Results Reference
background
PubMed Identifier
26468213
Citation
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.
Results Reference
result
Links:
URL
http://biotech-health.com/en/articles/57649.html
Description
publication of results
Available IPD and Supporting Information:
Available IPD/Information Type
publication
Available IPD/Information URL
https://www.ncbi.nlm.nih.gov/pubmed/26468213
Available IPD/Information Identifier
doi: 10.1177/1357633X15608984

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Telemedicine Strategy With Home Treatment Save Resources

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