A Feasibility Cluster RCT Investigating Improving Fluid Intake in Community-dwelling Urinary Catheterised District Nurse Patients Using an Innovative Prompting Cup, Education or a Combination of These Interventions.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Data Collection
研究概览
简要总结
PARCHED (Prompting And encouRaging Community Hydration through EDucation) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. The investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty.
PARCHED will randomise four areas in Cwm Taf University Health Board to receive one of four different interventions. Individuals will receive an intervention based on which area they live in, each participant will take part in the study for 12 weeks.
详细描述
PARCHED is a cluster feasibility randomized control trial (RCT) exploring the potential of an innovative prompting cup and education as person-centred and holistic tools to empower nursing leadership to reduce frailty in a catheterised community-dwelling population. This project will investigate interventions to improve hydration as potentially economically viable solutions to reducing frailty in a vulnerable population. Interventions have been developed using behaviour change theory and techniques. 80 participants will be recruited and will receive one of three interventions or usual care for a period of 12 weeks, data will be collected at baseline, 4 weeks and 12 weeks. Questionnaires, semi-structured interviews, and routine hospital records will be collected or accessed as part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •PARCHED will recruit district nurse patients at medium or high risk of dehydration (using the G, U and L of the GULP tool1),
- •with a urinary catheter,
- •living at home in community or residential care,
- •aged 18 years or above
排除标准
- •Inability to provide informed consent,
- •medical conditions or dietary restrictions that would substantially limit ability to complete study requirements (i.e. intravenous fluid intake, inability to lift cup),
- •living in nursing care setting,
- •end of life pathway,
- •diagnosed swallowing difficulty,
- •inability to communicate in English or Welsh.
结局指标
主要结局
Data Collection
时间窗: 12 weeks
Completion of Case Report Forms
Retention of District Nurses
时间窗: 12 Weeks
Recruitment of participants
时间窗: 12 Weeks
Acceptability and practicality of intervention for participants
时间窗: 12 Weeks
Participants will be approached to complete semi structured interviews which will explore the mechanisms and outcomes of the interventions.
Retention of participants
时间窗: 12 Weeks
次要结局
- Tilburg Frailty Indicator Questionnaire(12 weeks)
- Montreal cognitive assessment(12 weeks)
- Long-term follow up by NHS databases(12 months)
- Quality of life Questionnaire(12 weeks)
- PANAS mood questionnaire(12 weeks)
- Hydration self-efficacy Questionnaire(12 weeks)
- Hydration risk score (G, U and L of the GULP tool)(12 weeks)
- Semi-structured longitudinal interviews with District Nurses(12 weeks)
- Healthcare cost questionnaire(12 weeks)
- Evaluation Questionnaire(12 Weeks)
- Fluid and food frequency questionnaires(12 weeks)