Pro-Active Rehabilitation and Telephone Intervention in Type 2 Diabetics: a randomized controlled trial of patients enrolled in a DMP.
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00000058
- Lead Sponsor
- Rehabilitations-Forschungsnetzwerk der Deutschen Rentenversicherung Rheinland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 401
Inclusion Criteria
Study arm 1: Type 2 Diabetics enrolled in the DMP of a Germany health insurance company for at leas one year, rehabilitation need, 18 - 54 years.
Study arm 2 (telephone follow-up): 18 - 70 years, type 2 diabetes, German speakers, no acute substance-related disorder.
Exclusion Criteria
unsufficient language skills
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c (= 7%),<br>blood pressure (< 140/90 mm/Hg),<br>severe hypoglycemia,<br>global coronary risk (Cederholm, 2008),<br>complications. Assessments by questionnaire at screening for rehabilitation need and 12 months after screening. <br><br>Study arm 2 - telephone follow-up: Behavior change in physical activity (Stender et al., 1991), diet (food list based on Keller, 1998), medication adherence (MARS-D), smoking, improvements in depression (PHQ-9), well-being (WHO-5) and diabetes-related burden (PAID). Assessments by questionnaire at begin of inpatient rehabilitation and 12 months after discharge.<br>
- Secondary Outcome Measures
Name Time Method Social participation and<br>health related quality of life. Assessments by questionnaire at screening for rehabilitation need and 12 months after screening<br><br>Study arm 2 - telephone follwo-up: Blood glucose level (HbA1c), BMI, cardiovascular risk (Cederholm et al., 2008). <br>Data collection from medical records at begin of rehabiltiation and by questionnaire 12 months after discharge. <br>