Clinical trial NCT06255288: Time to Heal (Wound, Healing, Dialogue, Nutrition)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Ulcer
Venous Leg Ulcer
Arterial Leg Ulcer
Foot Ulcer, Diabetic
Amputation Stump
Keywords: Leg ulcer
Nutrition
Dialogue
Diet
Nursing
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Roskilde University
First posted: 2024-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SNAK Feasibility questionnaire (SFQ) - Element 1: Evaluating structured dialogue
timeFrame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
measure: SNAK Feasibility questionnaire (SFQ) - Element 2: Evaluating patient and relative information
timeFrame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
measure: SNAK Feasibility questionnaire (SFQ) - Element 3: Evaluating protein supplement
timeFrame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
measure: SNAK Feasibility questionnaire (SFQ) - Element 4: Evaluating overall intervention
timeFrame: Measurements will be taken within 1 week after their second and third visits to the outpatient clinic. Each patient will be followed up to maximum 16 weeks after inclusion.
measure: Qualitative evaluation of nurses' Capability, Opportunity, and Motivation (COM-B) to implement the intervention.
timeFrame: Measured 16 weeks after first inclusion.
measure: Procedural uncertainties - Number of patients willing to participate.
timeFrame: Measured 4, 8, 12, and 16 weeks after first inclusion.
Secondary outcomes:
measure: Recruitment rates
timeFrame: Every week until study completion (16 weeks after first inclusion).
measure: Drop out rates
timeFrame: Every week until study completion (16 weeks after first inclusion).
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital, Copenhagen
name: Pia Søe Jensen
role: PRINCIPAL_INVESTIGATOR
References: