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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19682354
Publication citations
-
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.