Diabetes Mellitus Type 2RenewingHealthNCT01580098

Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus

A study testing Self-monitoring for patients with Diabetes mellitus type 2 and Nurse-monitoring for patients with Diabetes mellitus type 2 in people with Diabetes Mellitus Type 2, run by Landeskrankenanstalten-Betriebsgesellschaft at 3 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: Self-monitoring for patients with Diabetes mellitus type 2 and Nurse-monitoring for patients with Diabetes mellitus type 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 193 participants
Where: 3 sitesAustria
Study dates: Feb 2010to Feb 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

T2DM diagnosed > 3 months prior to the enrollment
HbA1c >= 6,5 %
Capability of filling questionnaires by their own language
Being able to use the devices provided
Being cognitively able to participate

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

Austria3 sites

Klinikum Klagenfurt
Klagenfurt, Carinthia, 9020
LKH Laas
Kötschach, Carinthia, 9640
LKH Villach
Villach, Carinthia, 9500

Other trials in Austria

About this study

Official title: Regions of Europe Working Together for Health (Renewing Health)

Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

Conditions: Diabetes Mellitus Type 2
Being tested: Self-monitoring for patients with Diabetes mellitus type 2, Nurse-monitoring for patients with Diabetes mellitus type 2
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self-monitoring for patients with Diabetes mellitus type 2Other
Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurse-monitoring for patients with Diabetes mellitus type 2Other
Nurses are submitting the vital parameters of the patient via mobile device.

Study groups in NCT01580098
Study group	Role	What they receive
Control group	No intervention	treatment as usual
Self-monitoring for patients with Diabetes mellitus type 2	Experimental	Patients are self-monitoring and submitting their vital parameters. Receives: Other: Self-monitoring for patients with Diabetes mellitus type 2
Nurse-monitoring for patients with Diabetes mellitus type 2	Experimental	Nurses are measuring and entering the vital parameters of the patients. Receives: Other: Nurse-monitoring for patients with Diabetes mellitus type 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status.
Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests.
Measured: 12 months
HbA1c
HbA1c was taken at the beginning of the study and after 12 months.
Measured: 12 months

Secondary outcomes (6)

Blood Pressure
Measured: 12 months
Blood Lipids
Measured: 12 months
Body Weight
Measured: 12 months
Medication Changes
Insulin, Change? -> Yes/No
Measured: 12 months
Presence of Diabetic Complications
Measured: 12 months
Number of Hospitalisations
The number of inpatient stays comparing intervention and control group was conducted.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Feb 2014

First posted18 Apr 2012 (estimated)
Study startFeb 2010
Primary completionAug 2013
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus Type 2Studies 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: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01580098
Sponsor's protocol ID: D250487
Acronym: RenewingHealth
Status last verified: Apr 2015
First submitted: 17 Apr 2012
Last updated: 23 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Regions of Europe Working Together for Health (Renewing Health)
ClinicalTrials.gov ID: NCT01580098
Acronym / sponsor ID: RenewingHealth / D250487
Conditions: Diabetes Mellitus Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 193 participants (actual)
Lead sponsor: Landeskrankenanstalten-BetriebsgesellschaftIndustry (pharma, biotech, devices)
Collaborators: European Commission
Study start: Feb 2010
Primary completion: Aug 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 18 Apr 2012 (estimated)
Results: Posted 23 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control group	No intervention	–treatment as usual
Self-monitoring for patients with Diabetes mellitus type 2	Experimental	Other: Self-monitoring for patients with Diabetes mellitus type 2Patients are self-monitoring and submitting their vital parameters.
Nurse-monitoring for patients with Diabetes mellitus type 2	Experimental	Other: Nurse-monitoring for patients with Diabetes mellitus type 2Nurses are measuring and entering the vital parameters of the patients.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

T2DM diagnosed > 3 months prior to the enrollment
HbA1c >= 6,5 %
Capability of filling questionnaires by their own language
Being able to use the devices provided
Being cognitively able to participate

Key exclusion criteria (0 listed)

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
Self-monitoring for patients with Diabetes mellitus type 2Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.	Other	Self-monitoring for patients with Diabetes mellitus type 2
Nurse-monitoring for patients with Diabetes mellitus type 2Nurses are submitting the vital parameters of the patient via mobile device.	Other	Nurse-monitoring for patients with Diabetes mellitus type 2

Primary outcome

Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Time frame: 12 months
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests.
HbA1c
Time frame: 12 months
HbA1c was taken at the beginning of the study and after 12 months.

6 secondary outcomes

Blood Pressure
Time frame: 12 months
Blood Lipids
Time frame: 12 months
Body Weight
Time frame: 12 months
Medication Changes
Time frame: 12 months
Presence of Diabetic Complications
Time frame: 12 months
Number of Hospitalisations
Time frame: 12 months

Results and safety

Results posted to the registry on 23 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	76	61
Self-monitoring for Patients With Diabetes Mellitus Type 2	114	101
Nurse-monitoring for Patients With Diabetes Mellitus Type 2	3	0

Primary outcome: Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale (General health score)

Measure	Control Group n = 61	Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 n = 101
Physical Functioning 0-100 Score baseline	69.2 (25.8)	72.5 (25.2)
Physical Functioning 0-100 Score	74.9 (24.1)	77.1 (22.3)
Role Physical 0-100 Score baseline	58.5 (29.5)	63.8 (24.3)
Role Physical 0-100 Score	68.3 (29.3)	72.5 (25.1)
Bodily Pain 0-100 Score baseline	59.8 (33.6)	62.2 (31.0)
Bodily Pain 0-100 Score	66.7 (30.9)	66.5 (30.0)
General Health 0-100 Score baseline	62.6 (19.3)	62.2 (16.6)
General Health 0-100 Score	67.9 (17.9)	69.4 (18.8)

Population analysed: No patients of the Nurse-Monitoring Group finished the study, as a consequence no SF36 after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.

Primary outcome: HbA1c

Time frame: 12 months. Mean (Standard Deviation). Unit: HbA1c [%]

Measure	Control Group n = 61	Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 n = 101
HbA1c values: first examination	8.1 (1.2)	8.7 (1.9)
HbA1c values after 12 months	7.5 (1.1)	7.5 (1.5)

Control Group vs Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2: p = 0.025, Wilcoxon (Mann-Whitney)

Population analysed: No patients of the Nurse-Monitoring Group finished the study, as a consequence no HbA1c after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 61 (0%)	0 of 61 (0%)	Not reported
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2	0 of 101 (0%)	0 of 101 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus Type 2

Not yet recruitingPhase 3
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Active, not recruiting
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 0 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: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 23 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01580098.

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 23 Sep 2015.