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
Scientific
University of Witten / Herdecke, Alfred-Herrhausen-Str. 50
Witten
58448
Germany
| Phone | +49 (0)2302 926712 |
|---|---|
| monika.rieger@uni-wh.de |
Study information
| 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 |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 | 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 study start date | 01/12/2005 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
58448
Germany
Sponsor information
Federal Ministry of Education and Research (Bundesministerium fuer Bildung und Forschung) (BMBF) / German Aerospace Center (DLR)
Not defined
Not defined
BMBF
Projektträger im DLR Gesundheitsforschung
Heinrich-Konen-Str. 1
Bonn
53227
Germany
| Website | www.pt-dlr.de |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
