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

Study Overview
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Brief Summary
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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.

Official Title
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Regions of Europe Working Together for Health (Renewing Health)

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Other: Self-monitoring for patients with Diabetes mellitus type 2
* Other: Nurse-monitoring for patients with Diabetes mellitus type 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria:
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>treatment as usual | |
| Experimental: Self-monitoring for patients with Diabetes mellitus type 2<br>Patients are self-monitoring and submitting their vital parameters. | Other: Self-monitoring for patients with Diabetes mellitus type 2<br>* Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.<br>|
| Experimental: Nurse-monitoring for patients with Diabetes mellitus type 2<br>Nurses are measuring and entering the vital parameters of the patients. | Other: Nurse-monitoring for patients with Diabetes mellitus type 2<br>* Nurses are submitting the vital parameters of the patient via mobile device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| HbA1c | HbA1c was taken at the beginning of the study and after 12 months. | 12 months | 

Secondary Outcome Measures

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