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

NCT ID: NCT06255288

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-23
• Study Completion Date: 2024-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SNAK intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roskilde University

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pia Søe Jensen

Postdoc and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pia Søe Jensen

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital, Copenhagen

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

F-23054461

Identifier Type: -

Identifier Source: org_study_id