Contact information
Type
Scientific
Primary contact
Dr Peter Hübner
ORCID ID
Contact details
Hochstrasse 13-19
Bad Neuenahr
53474
Germany
+49 (0)2641 751 2105
peter.huebner@klinik-niederrhein.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05008
Study information
Scientific title
Acronym
Study hypothesis
An intermittent rehabilitation consisting of three weeks in-patient treatment, a follow up week after six months and frequent telephone calls leads to higher efficacy than standard rehabilitation.
Ethics approval
Applied to the ethics committee of the Medical School Hanover, awaiting approval as of 10/08/06.
Study design
Randomised controlled trial with one intervention and one control group.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Type two diabetes
Intervention
The intervention for both groups consists of a three week in-patient treatment. The goal is to improve diabetes specific knowledge and skills like balanced diet, physical exercise, foot care etc. Additionally the intervention group receives a follow-up week after six month to refresh the knowledge and gets expert advice every six weeks on the phone. This intensive care has the aim to remind and motivate the patients.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Metabolic parameter HbA1c
Secondary outcome measures
1. Cardiovascular Risk-Score PROCAM
2. Body Mass Index (BMI)
3. Diabetes related quality of life and coping skills
4. Satisfaction with therapy
5. Diabetes related costs
The data will be collected in the beginning, after the rehabilitation and one year later.
Overall trial start date
01/10/2006
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Covered by Deutsche Rentenversicherung (social pension fund)
2. Type two diabetes
3. Employable
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
420 patients
Participant exclusion criteria
1. Inadequate knowledge of the German language
2. Inadequate writing and literacy
3. Phone calls are impossible
4. Follow-up is impossible
5. Serious secondary disease
6. Not employable in the next 12 months
Recruitment start date
01/10/2006
Recruitment end date
30/09/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Hochstrasse 13-19
Bad Neuenahr
53474
Germany
Sponsor information
Organisation
Refonet (Germany)
Sponsor details
Burgweg 3
Bad Neuenahr
53474
Germany
+49 (0)2641 90620
service@refonet.de
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Refonet - Rehabilitations-Forschungsnetzwerk der Deutschen Rentenversicherung Rheinland (No. 05008) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary