Improve the Patients' Recovery With Family- Caregivers to End Delirium (NCT05118867) | Clinical Trial Compass
SuspendedNot Applicable
Improve the Patients' Recovery With Family- Caregivers to End Delirium
Stopped: To update technology based on feedback from participants
United States120 participantsStarted 2021-12-16
Plain-language summary
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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Patient Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of study recruitment to intervention study
Timeframe: Number approached for study that were eligible and number consented into study over 2-year study.
2
Usability and acceptability of digital technology
Timeframe: From enrollment through study completion, an average of 4 days
3
Delirium incidence
Timeframe: From enrollment through study completion, an average of 4 days