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

February 17, 2025 updated by: Pia Søe Jensen, Hvidovre University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2650
        • Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dialogue, patient information and protein supplement

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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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:

  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
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:

  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
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:

  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
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).
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.
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).
Measured 16 weeks after first inclusion.
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.

  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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Every week until study completion (16 weeks after first inclusion).
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.
Every week until study completion (16 weeks after first inclusion).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hvidovre University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roskilde University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pia Søe Jensen, Hvidovre University Hospital, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F-23054461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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