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

NCT06255288 | Completed

• 1 other identifier: F-23054461
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Leg ulcer; Nutrition; Dialogue; Diet; Nursing

Outcome Measures

Primary Outcomes (6)

• SNAK Feasibility questionnaire (SFQ) - Element 1: Evaluating structured dialogue

  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).

  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.

• SNAK Feasibility questionnaire (SFQ) - Element 2: Evaluating patient and relative information

  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).

  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.

• SNAK Feasibility questionnaire (SFQ) - Element 3: Evaluating protein supplement

  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).

  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.

• SNAK Feasibility questionnaire (SFQ) - Element 4: Evaluating overall intervention

  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).

  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.

• Qualitative evaluation of nurses' Capability, Opportunity, and Motivation (COM-B) to implement the intervention.

  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).

  Measured 16 weeks after first inclusion.

• Procedural uncertainties - Number of patients willing to participate.

  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.

  Measured 4, 8, 12, and 16 weeks after first inclusion.

Secondary Outcomes (2)

• Recruitment rates

  Every week until study completion (16 weeks after first inclusion).

• Drop out rates

  Every week until study completion (16 weeks after first inclusion).

Study Arms (1)

Dialogue, patient information and protein supplement

EXPERIMENTAL

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.

Other: SNAK intervention

Interventions

SNAK intervention OTHER

The intervention consists of structured dialogue, patient information, and a protein supplement. The structured dialogue part of the intervention consists of an A3 poster with illustrations and keywords which will be hanging in the outpatient clinics. The poster will be utilized by nurses, patients, and their relatives to facilitate a dialogue regarding nutrition and wound healing. The patient information part of the intervention consists of a leaflet with easy-to-read information, which patients and their relatives can bring home after their visit to the outpatient clinic. The leaflet will consist of general information as well as food categories and recipes they can use to enhance their daily protein intake. For the protein supplement part of the intervention, the patients will have access to protein supplement beverages while they are in the outpatient clinic waiting room. Furthermore, they will receive prescriptions for protein drinks, that they can pick up at their local pharmacy.

Dialogue, patient information and protein supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Roskilde University: collaborator

Study Sites (1)

Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital

Copenhagen, 2650, Denmark

Location

MeSH Terms

Conditions

Leg Ulcer; Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Pia Søe Jensen

  Hvidovre University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc and Associate Professor

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 13, 2024
• Study Start: January 23, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)