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

ISRCTN	ISRCTN42122226
DOI	https://doi.org/10.1186/ISRCTN42122226
Protocol serial number	01GL0507
Sponsor	Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung) (BMBF) / German Aerospace Center (DLR)
Funders	Main Sponsor:, Federal Ministry of Education and Research (BMBF)/German Aerospace Center (DLR) (ref. number: 01GL0507), Additional funding:, B. Braun foundation (Melsungen, Germany), Bauerfeind AG (Zeulenroda, Germany)

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

Primary study design	Interventional
Study design	Open, multicentre randomised controlled trial (randomisation on the level of general practioners' practices)
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TANDEM study
Study objectives	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(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) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key 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)
Key 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)
Date of first enrolment	01/12/2005
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

Germany

Study participating centre

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

Witten
58448
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	14/08/2009		Yes	No