Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| European Commission | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Nurse-monitoring for patients with Diabetes mellitus type 2 | Experimental | Nurses are measuring and entering the vital parameters of the patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-monitoring for patients with Diabetes mellitus type 2 | Other | Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | 12 months | |
| Blood Lipids | 12 months | |
| Body Weight |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Klagenfurt | Klagenfurt | Carinthia | 9020 | Austria | ||
| LKH Laas |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | treatment as usual |
| FG001 | Self-monitoring for Patients With Diabetes Mellitus Type 2 | Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital. |
| FG002 | Nurse-monitoring for Patients With Diabetes Mellitus Type 2 | nurse-monitoring for patients with Diabetes Mellitus Nurses are entering vital parameters of the patient with mobile devices |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | treatment as usual |
| BG001 | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital. Nurses are measuring and entering the vital parameters of the patients. Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device. No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm. Due to low enrollement in the Nurse Monitoring arm, it is combined in this module. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale (General health score) | 12 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | treatment as usual |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hannes Steinberger | Landeskrankenanstalten-Betriebsgesellschaft | +4346355212 50303 | hannes.steinberger@kabeg.at |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nurse-monitoring for patients with Diabetes mellitus type 2 | Other | Nurses are submitting the vital parameters of the patient via mobile device. |
|
| 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 |
| Kötschach |
| Carinthia |
| 9640 |
| Austria |
| LKH Villach | Villach | Carinthia | 9500 | Austria |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 |
Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital. Nurses are measuring and entering the vital parameters of the patients. Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device. No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm. Due to low enrollement in the Nurse Monitoring arm, it is combined in this module. |
|
|
| Primary | HbA1c | HbA1c was taken at the beginning of the study and after 12 months. | 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. | Posted | Mean | Standard Deviation | HbA1c [%] | 12 months |
|
|
|
|
| Secondary | Blood Pressure | Not all Participants delivered data, reliable data was used. No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood pressure after 12 months were delivered, so a calculation and evaluation for this group could not be conducted. | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
|
| Secondary | Blood Lipids | Not all Participants delivered reliable data; Measurements at the beginning of the trial and after 12 months; No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood lipids after 12 months were delivered, so a calculation and evaluation for this group could not be conducted. | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
| Secondary | Body Weight | baseline demographic characteristics; No patients of the Nurse-Monitoring Group finished the study, as a consequence no Body weight after 12 months were delivered, so a calculation and evaluation for this group could not be conducted. | Posted | Mean | Standard Deviation | kilograms | 12 months |
|
|
|
| Secondary | Medication Changes | Insulin, Change? -> Yes/No | No data about medical changes could be analysed at the end of the study, no data were collected. | Posted | 12 months |
|
|
| Secondary | Presence of Diabetic Complications | No data about the presence of diabetic complications could be analysed at the end of the study, no data was collected for this secondary outcome. | Posted | 12 months |
|
|
| Secondary | Number of Hospitalisations | The number of inpatient stays comparing intervention and control group was conducted. | Posted | Mean | Standard Deviation | number of inpatient stays | 12 months |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| EG001 | Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2 | Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital. Home nursing is also included. Nurses are measuring and entering the vital parameters of the patients. Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device. No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm. Due to low enrollement in the Nurse Monitoring arm, it is combined in this module. | 0 | 101 | 0 | 101 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| diastolic after 12 months |
|
| systolic after 12 months |
|
| Cholesterol after 12 months |
|
| Cholesterol after baseline |
|
| HDL-cholesterol after 12 months |
|
| HDL-cholesterol baseline |
|