A Pilot Clinical Trial of TENA Identifi in the Nursing Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Wet Events Per 24 Hours
研究概览
简要总结
The purpose of this study is to prospectively compare a standard of care manual toileting protocol (e.g., "check and change" strategy) to toileting patterns recorded by the TENA Identifi system in identifying incontinence patterns and events, and, whether such data differentially improve a care planning strategy, nursing effort, product use, and wet-time for urinary incontinence.
详细描述
Urinary incontinence in nursing homes influences resident dignity and quality of life. It also drives significant use of healthcare resources, including time and caregiver assistance, and costs of care. Various toileting programs are used to address urinary incontinence, including habit training, bladder training, prompted voiding, and check and change procedures. Clinical trials have found that 33% to 60% of residents either became continent or reduced the frequency of incontinence episodes to less than one per day with the introduction of a prompted voiding program.
There are several drawbacks to current programs. Manually recorded wet checks do not identify when incontinence occurs, only when wetness is detected, reducing the precision of time of incontinence to the window of time between checks. Nursing home staff create individualized care plans for each resident, based on standard check and change procedures, but poor precision in ascertaining timing and quantity of incontinence episodes can contribute to less frequent resident toileting or changing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 55 years of age or older with stable clinical status
- •Long-stay status (more than 90 days)
- •Ambulatory and able to use a toilet either independently or with assistance
- •Minimum Data Set (MDS) Level 1 (occasionally), 2 (frequently) or 3 (always) rating of incontinence
- •Currently wearing disposable briefs for urinary incontinence
排除标准
- •Chronically bed-bound (MDS G0110A rating 8)
- •MDS self-performance rating of 4 (total dependence) for toilet use
- •Fecal incontinence (MDS H0400 rating 0)
- •Use of urinary appliance such as catheters or ostomies (MDS H0100 Z)
- •Private duty nurse care
- •Residents who tear at clothing or disposable undergarments
- •Current urinary tract infection receiving treatment
- •Current diarrhea receiving treatment
- •Residents who are not likely to benefit from a toileting plan based on assessment of nursing staff
研究组 & 干预措施
TENA Identifi with sensor wear data
All individuals in this arm will receive care planning using TENA Identifi sensor wear data
干预措施: Care planning using TENA Identifi sensor wear data (Other)
TENA Identifi without sensor wear data
All individuals in this arm will receive care planning without using TENA Identifi sensor wear data
干预措施: Care planning without using TENA Identifi sensor wear data (Other)
结局指标
主要结局
Wet Events Per 24 Hours
时间窗: 6 days
Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control
次要结局
- Time Wet Per 24 Hours(6 days)
- Number of Brief Changes Per 24 Hours(6 days)