Intermittent rehabilitation in the therapy of type 2 diabetes

ISRCTN	ISRCTN23033749
DOI	https://doi.org/10.1186/ISRCTN23033749
Secondary identifying numbers	05008

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

Hochstrasse 13-19
Bad Neuenahr
53474
Germany

Phone	+49 (0)2641 751 2105
Email	peter.huebner@klinik-niederrhein.de

Study information

Study design	Randomised controlled trial with one intervention and one control group.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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	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 study start date	01/10/2006
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	420 patients
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

Sponsor information

Refonet (Germany)
Industry

Burgweg 3
Bad Neuenahr
53474
Germany

Phone	+49 (0)2641 90620
Email	service@refonet.de
Website	http://www.refonet.de
"ROR"	https://ror.org/04yeh2x21

Funders

Funder type

Industry

Refonet - Rehabilitations-Forschungsnetzwerk der Deutschen Rentenversicherung Rheinland (No. 05008) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.