Time to Heal (Wound, Healing, Dialogue, Nutrition) (SNAK)

Hvidovre University Hospital

Status: Enrolling

Conditions: Foot Ulcer, Diabetic; Venous Leg Ulcer; Amputation Stump; Arterial Leg Ulcer; Leg Ulcer

Treatments: Other: SNAK intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06255288

F-23054461

Details and patient eligibility

About

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.

Full description

The study aims to address the following research questions:

Primary Research Questions:

Is the patient recruitment process feasible? Is the delivery of the intervention feasible? Is the intervention acceptable to the patients? Is the intervention acceptable to the nurses? Is the intervention consistently maintained during the study period? Are the data collection procedures feasible? Are the outcome measures feasible? What are the reasons for any dropouts?

Secondary Research Questions:

What are the patients' and relatives' views on receiving the intervention? Are there any longitudinal differences in outcomes for the patient group? 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with leg ulcers caused by arterial or venous disease or neuropathy caused by diabetes.
• Patient with an amputation wound.
• Speak and understand Danish.

Exclusion criteria

• Patients with wounds caused by high-intensity trauma.
• Patients in the end-of-life phase.
• Patients living in nursing homes.
• Patients with cognitive impairment.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Dialogue, patient information and protein supplement

Experimental group

Description:

Patient will receive: Structured nutritional dialogue during two visits to the clinic. Written patient information (pamphlet) during their first visit to the clinic. Protein supplement drink during two visits to the clinic. Prescription of protein supplement drink during their first visit to the clinic.

Treatment:

Other: SNAK intervention