Improve the Patients' Recovery by Engagement and Partnerships With Family- CaregiveRs to End Delirium (iPREPARED) - A Feasibility and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Feasibility of study recruitment to intervention study
研究概览
简要总结
This research is being done to find out if patients and caregivers who use the iPREPARED mobile health technology experience less delirium, a type of acute confusion, and if they do experience delirium, the delirium will be less severe and distressful.
iPREPARED prepares patients and caregivers on what to expect during their hospital stay and provides instructions and resources on how to use non-pharmacologic strategies like re-orientation, distraction techniques, and other activities to maintain their brain health during their hospital stay.
详细描述
The purpose of this pilot study is to assess the feasibility, acceptability, and preliminary efficacy of the iPREPARED mobile health technology to reduce delirium incidence in a two-group, pilot randomized- controlled clinical trial. In the context of this intervention, the caregiver is defined as a patient-identified family member or friend that can accompany the patient in their hospital journey.
Aim 1: Determine the feasibility, acceptability, and usability of the iPREPARED intervention for use by older hospitalized adults (>60yo) and their caregivers (patient-caregiver dyad).
Aim 2: To estimate the effect size needed to reduce the incidence of delirium in participants using the iPREPARED intervention.
Aim 3: Identify patient-caregiver reported strategies to improve the usability of the iPREPARED intervention.
Secondary Outcomes:
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria:
- •60 years of age or older
- •Have 1 risk factor for delirium (pre-existing cognitive impairment, vision/hearing impairment, identified as high risk for falls, illness rated as severe)
- •Estimated length of stay of 24 hours or more in hospital
- •Have an informal caregiver (18 years of age or older, family member or friend) willing to participate
排除标准
- •Patient lacks capacity to consent
- •Unable to communicate or participate in study due to language barriers or sensory deficits
- •Prisoners
- •Documented history of dementia in the medical record
- •Patient admitted to hospice service or actively dying
- •Delirium present upon admission to hospital
- •COVID-19 positive test
- •Caregiver Inclusion Criteria:
- •18 years of age or older
- •Family member, friend, or neighbor of the patient willing to participate in the study and support the patient during the study period (support can be in-person or virtual)
- •Caregiver Exclusion Criteria:
- •- Unable or unwilling to participate due to language barriers, availability, or other communication barriers
研究组 & 干预措施
IPREPARED Hospital Recovery Club
Participants and their recovery partners (informal caregivers) will use the iPREPARED mobile health technology. They will watch a short video to prepare them for their hospital stay and asked to use the provided resources and tools to maintain their brain health during their hospital stay.
干预措施: iPREPARED (Behavioral)
Standard Hospital Care Group
Participants will receive standard protocolized care procedures.
结局指标
主要结局
Feasibility of study recruitment to intervention study
时间窗: Number approached for study that were eligible and number consented into study over 2-year study.
Total number of patient-caregiver dyads enrolled in the study
Usability and acceptability of digital technology
时间窗: From enrollment through study completion, an average of 4 days
Measured using the System Usability Scale and the treatment acceptability preference questionnaire which measure the participants self-reported usability and acceptability of the iPREPARED intervention.
Delirium incidence
时间窗: From enrollment through study completion, an average of 4 days
The incidence of delirium will be assessed upon enrollment then twice daily on days 1-4 of the study, and upon hospital discharge using the 3DCAM. Effect sizes between groups will be generated for future larger studies.
次要结局
- Acute Stress associated with the hospitalization(From enrollment through study completion, an average of 4 days)
- Delirium-related distress(From enrollment through study completion, an average of 4 days)
- Biomarkers(At enrollment and Day 4)
- 30-day readmission rates(30-days after hospital discharge date)
- Length of hospital stay(From enrollment through study completion, an average of 4 days)
- Delirium Severity(From enrollment through study completion, an average of 4 days)
- Discharge disposition(From enrollment through study completion, an average of 4 days)
- Resiliency(At enrollment into study)
- General Self-Rated Health Status(At enrollment into study)
研究者
Heidi L. Lindroth PhD RN
Principal Investigator
Mayo Clinic