DeliriumiPREPAREDNCT05118867
Improve the Patients' Recovery With Family- Caregivers to End Delirium
A study testing iPREPARED in people with Delirium, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- iPREPARED
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Improve the Patients' Recovery by Engagement and Partnerships With Family- CaregiveRs to End Delirium (iPREPARED) - A Feasibility and Acceptability Study
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.
Read the detailed description
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:
- Association between delirium incidence and self-rated health status (GSRH).
- Association between delirium incidence, severity, and delirium-related distress (NCCN Distress thermometer) and resiliency (BRS resiliency scale).
- Acute stress measured by the IPAT will be compared across the two groups. Acute stress measured by the Intensive Care Psychological Assessment Tool (IPAT) will be less in the intervention group.
- Delirium-related distress will be analyzed across the two groups. Delirium-related distress measured by the NCCN Distress Thermometer will be less in the intervention group.
- Plasma and serum biomarker differences between groups and between delirium/non- delirium cohort.
- Clinical outcomes including adverse hospital events (falls, nosocomial infections, aspirations), length of hospital stay, discharge disposition, mortality and 30-day readmission rates will be collected and examined between groups:
- Nosocomial infection is defined as a diagnosis not present on admission and occurred after 48 hours of hospital admission and includes UTI, Pneumonia, Decub ulcers, Cellulitis, CAUTI's and CLABSI's
- Conditions
- Delirium
- Being tested
- iPREPARED
- Keywords
- Aged 60 years old or older, Hospitalized with a risk of confusion, At risk of falling, At risk of vision or hearing impaired
- Medical subject headings
- Delirium, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPREPAREDBehavioural
iPREPARED is a mobile health technology that can be accessed via the web, tablet, or phone. It contains a preparatory video that outlines what to expect during the hospitalization. Instructional videos and examples are provided for the patient and their recovery partner to use to do their own reorientation, distraction techniques, physical activity, and sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| IPREPARED Hospital Recovery Club | Experimental | 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. Receives: Behavioral: iPREPARED |
| Standard Hospital Care Group | No intervention | Participants will receive standard protocolized care procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study recruitment to intervention study
Total number of patient-caregiver dyads enrolled in the study
Measured: Number approached for study that were eligible and number consented into study over 2-year study.
Usability and acceptability of digital technology
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.
Measured: From enrollment through study completion, an average of 4 days
Delirium incidence
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.
Measured: From enrollment through study completion, an average of 4 days
Secondary outcomes (9)
Delirium-related distress
The NCCN distress thermometer will be used twice daily to assess the level of self-reported distress associated with the signs and symptoms of delirium.
Measured: From enrollment through study completion, an average of 4 days
Resiliency
Measured using the brief resilience scale that assesses the participants ability to recover from stressful events through 6-item questionnaire asking participants to response to questions on a scale of strongly disagree, disagree, neutral, agree, or strongly agree.
Measured: At enrollment into study
General Self-Rated Health Status
Measured using the self-reported general self-rated health status (GSRH) asking participants to rate their general health as good, rather good, poor, or very poor.
Measured: At enrollment into study
Delirium Severity
Delirium severity will be assessed using the Delirium Rating Scale - R- 98 (DRS-R-98). This will be assessed upon enrollment, twice daily on hospital days 1-4, and upon discharge.
Measured: From enrollment through study completion, an average of 4 days
Acute Stress associated with the hospitalization
The Intensive Care Psychological Assessment Tool (IPAT) will be administered with concurrent delirium incidence and severity measurement.47 This is a 10-item scale that evaluates how a patient has been feeling since their admission. These answers will inform the delirium assessments.
Measured: From enrollment through study completion, an average of 4 days
Biomarkers
Plasma and serum biomarker differences between groups and between delirium/non-delirium cohort
Measured: At enrollment and Day 4
Discharge disposition
Place (home, rehabilitation facility, long term care facility) that patient was discharged from the hospital to for continued care.
Measured: From enrollment through study completion, an average of 4 days
30-day readmission rates
Rate of patients that were re-admitted to the hospital following the index hospitalization
Measured: 30-days after hospital discharge date
Length of hospital stay
Number of days admitted to hospital
Measured: From enrollment through study completion, an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start16 Dec 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: To update technology based on feedback from participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi L. Lindroth PhD RN, Mayo Clinic
- Investigators
- Heidi Lindroth, PhD, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118867
- Sponsor's protocol ID
- 21-005022
- Acronym
- iPREPARED
- Status last verified
- Apr 2026
- First submitted
- 8 Oct 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with the NIDUS network and for other interested investigators. Please contact study team.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve the Patients' Recovery by Engagement and Partnerships With Family- CaregiveRs to End Delirium (iPREPARED) - A Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT05118867
- Acronym / sponsor ID
- iPREPARED / 21-005022
- Conditions
- Delirium
- Keywords
- Aged 60 years old or older, Hospitalized with a risk of confusion, At risk of falling, At risk of vision or hearing impaired
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: To update technology based on feedback from participants
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Association between delirium incidence and self-rated health status (GSRH).
- Association between delirium incidence, severity, and delirium-related distress (NCCN Distress thermometer) and resiliency (BRS resiliency scale).
- Acute stress measured by the IPAT will be compared across the two groups. Acute stress measured by the Intensive Care Psychological Assessment Tool (IPAT) will be less in the intervention group.
- Delirium-related distress will be analyzed across the two groups. Delirium-related distress measured by the NCCN Distress Thermometer will be less in the intervention group.
- Plasma and serum biomarker differences between groups and between delirium/non- delirium cohort.
- Clinical outcomes including adverse hospital events (falls, nosocomial infections, aspirations), length of hospital stay, discharge disposition, mortality and 30-day readmission rates will be collected and examined between groups:
- Nosocomial infection is defined as a diagnosis not present on admission and occurred after 48 hours of hospital admission and includes UTI, Pneumonia, Decub ulcers, Cellulitis, CAUTI's and CLABSI's
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPREPARED Hospital Recovery Club | Experimental | Behavioral: iPREPAREDParticipants 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. |
| Standard Hospital Care Group | No intervention | –Participants will receive standard protocolized care procedures. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPREPAREDiPREPARED is a mobile health technology that can be accessed via the web, tablet, or phone. It contains a preparatory video that outlines what to expect during the hospitalization. Instructional videos and examples are provided for the patient and their recovery partner to use to do their own reorientation, distraction techniques, physical activity, and sleep hygiene. | Behavioural | IPREPARED Hospital Recovery Club |
Primary outcome
Feasibility of study recruitment to intervention study
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Delirium-related distress
Time frame: From enrollment through study completion, an average of 4 days
Resiliency
Time frame: At enrollment into study
General Self-Rated Health Status
Time frame: At enrollment into study
Delirium Severity
Time frame: From enrollment through study completion, an average of 4 days
Acute Stress associated with the hospitalization
Time frame: From enrollment through study completion, an average of 4 days
Biomarkers
Time frame: At enrollment and Day 4
Discharge disposition
Time frame: From enrollment through study completion, an average of 4 days
30-day readmission rates
Time frame: 30-days after hospital discharge date
Length of hospital stay
Time frame: From enrollment through study completion, an average of 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared with the NIDUS network and for other interested investigators. Please contact study team.
Related trials for Delirium
RecruitingObservational study
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Lindroth, PhD, RN principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPREPARED in people with Delirium, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study recruitment to intervention study (time frame: Number approached for study that were eligible and number consented into study over 2-year study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.