Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2006
Date assigned
04/12/2006
Last edited
04/12/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.refonet.de

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

Publication citations

Additional files

Editorial Notes