N/A
Completed N=193
Medium-term Health Coaching and Life-long Monitoring in Diabetes Mellitus
Source: ClinicalTrials.gov NCT01580098 ↗Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire — 69.2; 72.5; 74.9; 77.1 units on a scale (General health score)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire |
69.2; 72.5; 74.9; 77.1; 58.5; 63.8 | — |
| PRIMARY HbA1c |
8.1; 8.7; 7.5; 7.5 | 0.025 sig |
| SECONDARY Blood Pressure |
86.7; 88.9; 150.4; 153.7; 85.2; 84.8 | 0.182 |
| SECONDARY Blood Lipids |
104.3; 107.6; 107.5; 112.1; 185.2; 186.1 | — |
| SECONDARY Body Weight |
90.2; 90.74; 91.22; 91.64 | — |
| SECONDARY Medication Changes |
— | — |
| SECONDARY Presence of Diabetic Complications |
— | — |
| SECONDARY Number of Hospitalisations |
0.33; 0.38 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01580098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.