Condition category
Circulatory System
Date applied
03/07/2006
Date assigned
28/07/2006
Last edited
07/01/2010
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 Monika A. Rieger

ORCID ID

Contact details

University of Witten / Herdecke
Alfred-Herrhausen-Str. 50
Witten
58448
Germany
+49 (0)2302 926712
monika.rieger@uni-wh.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GL0507

Study information

Scientific title

Acronym

TANDEM study

Study hypothesis

Does an additional nurse-led education programme improve wound healing, Health Related Quality of Life (HRQoL), and recurrence rates in patients suffering from venous leg ulcers treated by general practioners?

Ethics approval

Ethics committee of the University of Witten/Herdecke (reference number: 21/2005), date of approval: 17/05/2005 (first amendment: 28/10/2005, second amendment: 22/06/2006).

Study design

Open, multicentre randomised controlled trial (randomisation on the level of general practioners' practices)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

Venous leg ulcers

Intervention

Nurses offer an education programme to patients receiving usual care by their general practitioner (GP). In addition, the nurse specialist offers support to the medical doctor himself. The content of the nurse-led education programme was based on an evidence-based self-care activity catalogue which was derived from national and international clinical guidelines. The teaching of the nurse specialists was based on the theory of self-care competence. The control group received usual care from their GP, but not the nurse led education programme.

Both groups, the medical doctors in the intervention and in the control group, received written information on the "state-of-the- art"-therapy of patients with venous leg ulcers (short and comprehensive version of the actual official guideline).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

At 12 weeks (+/- two weeks)(t2):
1. Wound healing (proportion of healed leg ulcers)
2. Reduction of wound area (measured by digital planimetry)
3. Health-related quality of life (Freiburg Life Quality Assessment (FLQA), scale 1: physical complaints)

Secondary outcome measures

At six weeks (+/- one week)(t1), 12 weeks (+/- two weeks)(t2), 24 weeks (+/- four weeks)(t3) and 52 weeks (+/- four weeks)(t4) secondary outcomes:
1. Characteristics of healing (using the Leg Ulcer Measurement Tool [LUMT])
2. Health-related quality of life using the FLQA
3. Self-care competence
4. Health economic evaluation (use of resources
5. Costs of the intervention
6. Satisfaction and personal opinion of all concerned subjects (patients, medical doctors and their teams, relatives, nurses)

Overall trial start date

01/12/2005

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients suffering from venous leg ulcers (stadium C6 according to CEAP classification)
2. Patients receiving treatment in a study practice
3. Patients have an ability of self-care (or the control of dependent care e.g. by relatives)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Exclusion criteria (before the study i.e.: no inclusion):
1. Other stadium of chronic venous insufficiency
2. Other etiology of the leg ulcer (e.g. arterial insufficiency, ulcus mixtum, diabetic foot)
3. Cognitive impairment (hindering self-care)
4. Insuffient competence of the German language
5. Inability to read
6. Parallel participation in another clinical trial

Exclusion criteria (during the study):
1. Change of the general practitioner during the first six months after inclusion in the study
2. Ending of the study participation of the general practitioner
3. In-patient treatment (at least for 14 days)
4. Newly developed severe illness (hindering self-care)

Recruitment start date

01/12/2005

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Germany

Trial participating centre

University of Witten / Herdecke, Alfred-Herrhausen-Str. 50
Witten
58448
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung) (BMBF) / German Aerospace Center (DLR)

Sponsor details

BMBF
Projektträger im DLR Gesundheitsforschung
Heinrich-Konen-Str. 1
Bonn
53227
Germany

Sponsor type

Not defined

Website

www.pt-dlr.de

Funders

Funder type

Government

Funder name

Main Sponsor:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal Ministry of Education and Research (BMBF)/German Aerospace Center (DLR) (ref. number: 01GL0507)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Additional funding:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

B. Braun foundation (Melsungen, Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bauerfeind AG (Zeulenroda, 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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19682354

Publication citations

  1. Results

    Herber OR, Schnepp W, Rieger MA, Recruitment rates and reasons for community physicians' non-participation in an interdisciplinary intervention study on leg ulceration., BMC Med Res Methodol, 2009, 9, 61, doi: 10.1186/1471-2288-9-61.

Additional files

Editorial Notes