Trial Outcomes & Findings for Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus (NCT NCT01580098)
NCT ID: NCT01580098
Last Updated: 2015-09-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
193 participants
Primary outcome timeframe
12 months
Results posted on
2015-09-23
Participant Flow
Participant milestones
| Measure |
Control Group
treatment as usual
|
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.
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
76
|
114
|
3
|
|
Overall Study
COMPLETED
|
61
|
101
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Control Group
n=76 Participants
treatment as usual
|
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
n=117 Participants
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.
|
Total
n=193 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.38 years
STANDARD_DEVIATION 11.13 • n=5 Participants
|
60.35 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
61.54 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
76 participants
n=5 Participants
|
117 participants
n=7 Participants
|
193 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control Group
n=61 Participants
treatment as usual
|
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
n=101 Participants
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.
|
|---|---|---|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Physical Functioning 0-100 Score baseline
|
69.2 units on a scale (General health score)
Standard Deviation 25.8
|
72.5 units on a scale (General health score)
Standard Deviation 25.2
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Physical Functioning 0-100 Score
|
74.9 units on a scale (General health score)
Standard Deviation 24.1
|
77.1 units on a scale (General health score)
Standard Deviation 22.3
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Role Physical 0-100 Score baseline
|
58.5 units on a scale (General health score)
Standard Deviation 29.5
|
63.8 units on a scale (General health score)
Standard Deviation 24.3
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Role Physical 0-100 Score
|
68.3 units on a scale (General health score)
Standard Deviation 29.3
|
72.5 units on a scale (General health score)
Standard Deviation 25.1
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Bodily Pain 0-100 Score baseline
|
59.8 units on a scale (General health score)
Standard Deviation 33.6
|
62.2 units on a scale (General health score)
Standard Deviation 31.0
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Bodily Pain 0-100 Score
|
66.7 units on a scale (General health score)
Standard Deviation 30.9
|
66.5 units on a scale (General health score)
Standard Deviation 30.0
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
General Health 0-100 Score baseline
|
62.6 units on a scale (General health score)
Standard Deviation 19.3
|
62.2 units on a scale (General health score)
Standard Deviation 16.6
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
General Health 0-100 Score
|
67.9 units on a scale (General health score)
Standard Deviation 17.9
|
69.4 units on a scale (General health score)
Standard Deviation 18.8
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Vitality 0-100 Score baseline
|
56.3 units on a scale (General health score)
Standard Deviation 25.7
|
58.4 units on a scale (General health score)
Standard Deviation 62.5
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Vitality 0-100 Score
|
61.6 units on a scale (General health score)
Standard Deviation 23.6
|
63.2 units on a scale (General health score)
Standard Deviation 19.1
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Social Functioning 0-100 Score baseline
|
80.1 units on a scale (General health score)
Standard Deviation 23.1
|
81.3 units on a scale (General health score)
Standard Deviation 22.1
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Social Functioning 0-100 Score
|
86.7 units on a scale (General health score)
Standard Deviation 18.8
|
81.3 units on a scale (General health score)
Standard Deviation 26.6
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Role Emotional 0-100 Score baseline
|
67.5 units on a scale (General health score)
Standard Deviation 28.2
|
70.7 units on a scale (General health score)
Standard Deviation 24.5
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Role Emotional 0-100 Score
|
77.7 units on a scale (General health score)
Standard Deviation 28.4
|
78.7 units on a scale (General health score)
Standard Deviation 25.3
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Mental Health 0-100 Score baseline
|
72.2 units on a scale (General health score)
Standard Deviation 21.7
|
72.1 units on a scale (General health score)
Standard Deviation 18.8
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Mental Health 0-100 Score
|
76.1 units on a scale (General health score)
Standard Deviation 19.6
|
72.6 units on a scale (General health score)
Standard Deviation 20.1
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
PCS Physical Component Score baseline
|
43.7 units on a scale (General health score)
Standard Deviation 10.4
|
45.1 units on a scale (General health score)
Standard Deviation 9.9
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
PCS Physical Component Score
|
46.3 units on a scale (General health score)
Standard Deviation 9.6
|
47.9 units on a scale (General health score)
Standard Deviation 9.5
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
MCS Mental Component Score baseline
|
47.2 units on a scale (General health score)
Standard Deviation 11.9
|
47.9 units on a scale (General health score)
Standard Deviation 11.7
|
|
Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
MCS Mental Component Score
|
50.6 units on a scale (General health score)
Standard Deviation 11.9
|
49.1 units on a scale (General health score)
Standard Deviation 11.6
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
HbA1c was taken at the beginning of the study and after 12 months.
Outcome measures
| Measure |
Control Group
n=61 Participants
treatment as usual
|
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
n=101 Participants
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.
|
|---|---|---|
|
HbA1c
HbA1c values: first examination
|
8.1 HbA1c [%]
Standard Deviation 1.2
|
8.7 HbA1c [%]
Standard Deviation 1.9
|
|
HbA1c
HbA1c values after 12 months
|
7.5 HbA1c [%]
Standard Deviation 1.1
|
7.5 HbA1c [%]
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Outcome measures
| Measure |
Control Group
n=54 Participants
treatment as usual
|
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
n=77 Participants
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.
|
|---|---|---|
|
Blood Pressure
diastolic baseline
|
86.7 mmHg
Standard Deviation 12.9
|
88.9 mmHg
Standard Deviation 12.6
|
|
Blood Pressure
systolic baseline
|
150.4 mmHg
Standard Deviation 21.3
|
153.7 mmHg
Standard Deviation 23.1
|
|
Blood Pressure
diastolic after 12 months
|
85.2 mmHg
Standard Deviation 13.0
|
84.8 mmHg
Standard Deviation 12.6
|
|
Blood Pressure
systolic after 12 months
|
149.3 mmHg
Standard Deviation 21.1
|
148.7 mmHg
Standard Deviation 23.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Outcome measures
| Measure |
Control Group
n=56 Participants
treatment as usual
|
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
n=81 Participants
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.
|
|---|---|---|
|
Blood Lipids
LDL Cholesterol after 12 months
|
104.3 mg/dL
Standard Deviation 38.7
|
107.6 mg/dL
Standard Deviation 44.2
|
|
Blood Lipids
LDL Cholesterol baseline
|
107.5 mg/dL
Standard Deviation 36.3
|
112.1 mg/dL
Standard Deviation 42.5
|
|
Blood Lipids
Cholesterol after 12 months
|
185.2 mg/dL
Standard Deviation 41.6
|
186.1 mg/dL
Standard Deviation 51.3
|
|
Blood Lipids
Cholesterol after baseline
|
186.8 mg/dL
Standard Deviation 37.8
|
197.6 mg/dL
Standard Deviation 53.1
|
|
Blood Lipids
HDL-cholesterol after 12 months
|
51.3 mg/dL
Standard Deviation 17.6
|
48.1 mg/dL
Standard Deviation 16.9
|
|
Blood Lipids
HDL-cholesterol baseline
|
48.2 mg/dL
Standard Deviation 16.8
|
47.1 mg/dL
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Outcome measures
| Measure |
Control Group
n=61 Participants
treatment as usual
|
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
n=101 Participants
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.
|
|---|---|---|
|
Body Weight
body weight baseline
|
90.2 kilograms
Standard Deviation 19.0
|
90.74 kilograms
Standard Deviation 20.0
|
|
Body Weight
body weight after 12 months
|
91.22 kilograms
Standard Deviation 19.32
|
91.64 kilograms
Standard Deviation 19.94
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: No data about medical changes could be analysed at the end of the study, no data were collected.
Insulin, Change? -\> Yes/No
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsThe number of inpatient stays comparing intervention and control group was conducted.
Outcome measures
| Measure |
Control Group
n=76 Participants
treatment as usual
|
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
n=117 Participants
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.
|
|---|---|---|
|
Number of Hospitalisations
|
0.33 number of inpatient stays
Standard Deviation 0.63
|
0.38 number of inpatient stays
Standard Deviation 0.71
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hannes Steinberger
Landeskrankenanstalten-Betriebsgesellschaft
Phone: +4346355212 50303
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place