Venous Leg Ulcer Clinical Trial
Official title:
A Nurse-led Intervention Consisting of a Structured Dialogue, Patient and Relative Information, and Protein Supplement for Patients With Leg Ulcers in Clinical Practice: A Feasibility Study
The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.
The study aims to address the following research questions: Primary Research Questions: 1. Is the patient recruitment process feasible? 2. Is the delivery of the intervention feasible? 3. Is the intervention acceptable to the patients? 4. Is the intervention acceptable to the nurses? 5. Is the intervention consistently maintained during the study period? 6. Are the data collection procedures feasible? 7. Are the outcome measures feasible? 8. What are the reasons for any dropouts? Secondary Research Questions: 1. What are the patients' and relatives' views on receiving the intervention? 2. Are there any longitudinal differences in outcomes for the patient group? 3. Are there any individual patient-specific differences in outcomes over time? The feasibility study will recruit patients with a first-time referral to the outpatient clinic at the Department of Orthopaedic Surgery at Copenhagen University Hospital, Hvidovre, for leg ulcers caused by arterial or venous disease or neuropathy due to diabetes. The intervention will be administered by the clinic's nurses. After inclusion, each patient will be contacted by telephone following their next two clinic visits. The initial follow-up will assess patient characteristics, information about their wound using the Wound-Qol Questionnaire, and their perspective on receiving the intervention. The second and final follow-up will consist of an interview exploring their perspective on receiving the intervention. Additionally, focus group interviews with the nurses will be conducted to investigate their capability, opportunity, and motivation (COM-B model) for implementing the intervention. Both patient and nurse interviews will be recorded and transcribed. ;
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