- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06255288
Time to Heal (Wound, Healing, Dialogue, Nutrition) (SNAK)
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 Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pia Søe Jensen, PhD
- Phone Number: +45 3862 2464
- Email: pjen0002@regionh.dk
Study Contact Backup
- Name: Christine K Schrøder, MHSc
- Email: christine.krogsgaard.schroeder@regionh.dk
Study Locations
-
-
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Copenhagen, Denmark, 2650
- Recruiting
- Outpatient clinic at the Department of Orthopedic Surgery, Hvidovre University Hospital
-
Contact:
- Pia Søe Jensen, PhD
- Phone Number: +45 3862 2464
- Email: pjen0002@regionh.dk
-
Contact:
- Christine K Schrøder, MHSc
- Email: christine.krogsgaard.schroeder@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
---|---|
Experimental: Dialogue, patient information and protein supplement
Patient will receive:
|
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
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:
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:
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:
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.
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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).
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Measured 16 weeks after first inclusion.
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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 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
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).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pia Søe Jensen, Hvidovre University Hospital, Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-23054461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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