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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- SNAK Feasibility questionnaire (SFQ) - Element 3: Evaluating protein supplement
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with leg ulcers caused by arterial or venous disease or neuropathy caused by diabetes.
- •Patient with an amputation wound.
- •Speak and understand Danish.
排除标准
- •Patients with wounds caused by high-intensity trauma.
- •Patients in the end-of-life phase.
- •Patients living in nursing homes.
- •Patients with cognitive impairment.
结局指标
主要结局
SNAK Feasibility questionnaire (SFQ) - Element 3: Evaluating protein supplement
时间窗: 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).
Qualitative evaluation of nurses' Capability, Opportunity, and Motivation (COM-B) to implement the intervention.
时间窗: 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).
Procedural uncertainties - Number of patients willing to participate.
时间窗: 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.
SNAK Feasibility questionnaire (SFQ) - Element 1: Evaluating structured dialogue
时间窗: 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).
SNAK Feasibility questionnaire (SFQ) - Element 4: Evaluating overall intervention
时间窗: 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).
SNAK Feasibility questionnaire (SFQ) - Element 2: Evaluating patient and relative information
时间窗: 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).
次要结局
- 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).)
研究者
Pia Søe Jensen
Postdoc and Associate Professor
Hvidovre University Hospital