Intermittent rehabilitation in the therapy of type 2 diabetes
| ISRCTN | ISRCTN23033749 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23033749 |
| Protocol serial number | 05008 |
| Sponsor | Refonet (Germany) |
| Funder | Refonet - Rehabilitations-Forschungsnetzwerk der Deutschen Rentenversicherung Rheinland (No. 05008) (Germany) |
- Submission date
- 10/08/2006
- Registration date
- 04/12/2006
- Last edited
- 06/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Hübner
Scientific
Scientific
Hochstrasse 13-19
Bad Neuenahr
53474
Germany
| Phone | +49 (0)2641 751 2105 |
|---|---|
| peter.huebner@klinik-niederrhein.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial with one intervention and one control group. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Intermittent rehabilitation in the therapy of type 2 diabetes |
| Study objectives | An intermittent rehabilitation consisting of 3 weeks in-patient treatment, a follow up week after 6 months and frequent telephone calls leads to higher efficacy than standard rehabilitation. |
| Ethics approval(s) | Applied to the ethics committee of the Medical School Hanover, awaiting approval as of 10/08/06. |
| Health condition(s) or problem(s) studied | Type two diabetes |
| Intervention | The intervention for both groups consists of a 3-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 6 months to refresh the knowledge and gets expert advice every 6 weeks on the phone. This intensive care has the aim to remind and motivate the patients. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Metabolic parameter HbA1c |
| Key secondary outcome measure(s) |
1. Cardiovascular Risk-Score PROCAM |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 420 |
| Total final enrolment | 420 |
| Key inclusion criteria | 1. Covered by Deutsche Rentenversicherung (social pension fund) 2. Type 2 diabetes 3. Employable |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Hochstrasse 13-19
Bad Neuenahr
53474
Germany
53474
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2009 | 06/01/2021 | Yes | No |
Editorial Notes
06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
