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Completed

NCT Number: NCT06255288

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

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.

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Key information

Conditions

Leg Ulcer Amputation Stump Arterial Leg Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Foot Ulcer, Diabetic Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Venous Leg Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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:

    • Noticed the dialogue tool.
    • Had a conversation with the nurses about nutrition and wound healing using the dialogue tool.
    • Found the conversation with the nurses about nutrition and wound healing relevant and valuable.
    • 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).

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

    Time frame: 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:

    • Received a leaflet.
    • Could read and understand the leaflet.
    • Found the information in the leaflet relevant.
    • have attempted to use the suggested recipes or food categories.
    • 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).

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

    Time frame: 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:

    • Were offered a protein supplement drink.
    • Were offered a prescription for protein supplement drinks.
    • 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).

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

    Time frame: 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).

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

    Time frame: 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).

  6. Procedural uncertainties - Number of patients willing to participate.

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

    Following criteria are considered to evaluate the recruitment of participation in the intervention.

    • If less than 30% are willing to participate in the intervention, then the intervention is considered non-feasible.
    • 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.

Secondary outcomes

  1. Recruitment rates

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

    The number of eligible patients that agree to participate will be collected.

  2. Drop out rates

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Roskilde University

Registry information

Official study 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

Acronym: SNAK

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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