Regions of Europe Working Together for Health (Renewing Health)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 193
- Locations
- 6
- Primary Endpoint
- Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Blood Pressure(12 months)
- Blood Lipids(12 months)
- Body Weight(12 months)
- Medication Changes(12 months)
- Presence of Diabetic Complications(12 months)
- Number of Hospitalisations(12 months)