Enhancing self-care in leg ulcer patients: tandem practices as a model for interdisciplinary care

ISRCTN ISRCTN42122226
DOI https://doi.org/10.1186/ISRCTN42122226
Secondary identifying numbers 01GL0507
Submission date
03/07/2006
Registration date
28/07/2006
Last edited
07/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Monika A. Rieger
Scientific

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

Phone +49 (0)2302 926712
Email monika.rieger@uni-wh.de

Study information

Study designOpen, multicentre randomised controlled trial (randomisation on the level of general practioners' practices)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeQuality of life
Scientific title
Study acronymTANDEM study
Study objectivesDoes 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(s)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).
Health condition(s) or problem(s) studiedVenous leg ulcers
InterventionNurses 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 typeOther
Primary outcome measureAt 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 measuresAt 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 study start date01/12/2005
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteria1. 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)
Key exclusion criteriaExclusion 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)
Date of first enrolment01/12/2005
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

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

Sponsor information

Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung) (BMBF) / German Aerospace Center (DLR)
Not defined

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

Website www.pt-dlr.de
ROR logo "ROR" https://ror.org/04pz7b180

Funders

Funder type

Government

Main Sponsor:

No information available

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

No information available

Additional funding:

No information available

B. Braun foundation (Melsungen, Germany)

No information available

Bauerfeind AG (Zeulenroda, Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/08/2009 Yes No