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

Not Applicable

Completed

• Conditions: Venous Leg Ulcer; Amputation Stump; Arterial Leg Ulcer; Foot Ulcer, Diabetic; Leg Ulcer
• Interventions: Other: SNAK intervention

• Registration Number: NCT06255288
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Study Start: 2024-01-23
• Study First Submitted: 2024-01-25
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-13
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dialogue, patient information and protein supplement	SNAK intervention	Patient will receive: 1. Structured nutritional dialogue during two visits to the clinic. 2. Written patient information (pamphlet) during their first visit to the clinic. 3. Protein supplement drink during two visits to the clinic. 4. Prescription of protein supplement drink during their first visit to the clinic.

Primary Outcome Measures

Name	Time	Method
SNAK Feasibility questionnaire (SFQ) - Element 3: Evaluating protein supplement	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.	The intervention is considered non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients: 1. Were offered a protein supplement drink.; 2. Were offered a prescription for protein supplement drinks.; 3. Agree that patients should be offered a protein supplement drink.; The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
Qualitative evaluation of nurses' Capability, Opportunity, and Motivation (COM-B) to implement the intervention.	Measured 16 weeks after first inclusion.	COM-B will be explored using a semi-structured focus group interview with the nurses and will be carried out in the outpatient clinic following the end of inclusion (16 weeks after first inclusion).
Procedural uncertainties - Number of patients willing to participate.	Measured 4, 8, 12, and 16 weeks after first inclusion.	Following criteria are considered to evaluate the recruitment of participation in the intervention.; 1. If less than 30% are willing to participate in the intervention, then the intervention is considered non-feasible.; 2. If recruitment falls within the range of 30 to 80% modification will be considered.; If 80% or more are recruited, the study is deemed feasible without modification.
SNAK Feasibility questionnaire (SFQ) - Element 1: Evaluating structured dialogue	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.	The intervention is deemed non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients: 1. Noticed the dialogue tool.; 2. Had a conversation with the nurses about nutrition and wound healing using the dialogue tool.; 3. Found the conversation with the nurses about nutrition and wound healing relevant and valuable.; 4. Considered it acceptable to have a conversation with the nurses about nutrition and wound healing.; The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
SNAK Feasibility questionnaire (SFQ) - Element 4: Evaluating overall intervention	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.	The intervention is considered non-feasible if fewer than 80% of the patients, during their visit to the outpatient clinic, are confident that they can follow the advice regarding nutrition and lifestyle in their daily lives.; The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).
SNAK Feasibility questionnaire (SFQ) - Element 2: Evaluating patient and relative information	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.	The intervention is considered non-feasible if, during their visit to the outpatient clinic, fewer than 80% of the patients: 1. Received a leaflet.; 2. Could read and understand the leaflet.; 3. Found the information in the leaflet relevant.; 4. have attempted to use the suggested recipes or food categories.; 5. have attempted to change their diet.; The SFQ has two scoring systems: 1) Binary scores (yes/no) with a non-applicable option as well and 2) categorical 5-point score (1 is the highest score and 5 is the lowest score in regards to agreement on statements related to the interventions feasibility). The 5-point categorical score will be presented with median and interquartile ranges (IQR).

Secondary Outcome Measures

Name	Time	Method
Recruitment rates	Every week until study completion (16 weeks after first inclusion).	The number of eligible patients that agree to participate will be collected.
Drop out rates	Every week until study completion (16 weeks after first inclusion).	The number of included patients that withdraw consent or drop out for other reasons will be collected. Furthermore, we will collect reasons for dropout.

Trial Locations

Locations (1)

Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital; 🇩🇰 Copenhagen, Denmark