Improve the Patients' Recovery With Family- Caregivers to End Delirium (iPREPARED)

April 2, 2026 updated by: Heidi L. Lindroth PhD RN, Mayo Clinic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. Association between delirium incidence and self-rated health status (GSRH).
  2. Association between delirium incidence, severity, and delirium-related distress (NCCN Distress thermometer) and resiliency (BRS resiliency scale).
  3. 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.
  4. 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.
  5. Plasma and serum biomarker differences between groups and between delirium/non- delirium cohort.

  6. 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:

    1. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: iPREPARED
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.
No Intervention: Standard Hospital Care Group
Participants will receive standard protocolized care procedures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Number approached for study that were eligible and number consented into study over 2-year 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.
From enrollment through study completion, an average of 4 days
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.
From enrollment through study completion, an average of 4 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delirium-related distress
Time Frame: From enrollment through study completion, an average of 4 days
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.
From enrollment through study completion, an average of 4 days
Resiliency
Time Frame: At enrollment into study
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.
At enrollment into study
General Self-Rated Health Status
Time Frame: At enrollment into study
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.
At enrollment into study
Delirium Severity
Time Frame: From enrollment through study completion, an average of 4 days
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.
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
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.
From enrollment through study completion, an average of 4 days
Biomarkers
Time Frame: At enrollment and Day 4
Plasma and serum biomarker differences between groups and between delirium/non-delirium cohort
At enrollment and Day 4
Discharge disposition
Time Frame: From enrollment through study completion, an average of 4 days
Place (home, rehabilitation facility, long term care facility) that patient was discharged from the hospital to for continued care.
From enrollment through study completion, an average of 4 days
30-day readmission rates
Time Frame: 30-days after hospital discharge date
Rate of patients that were re-admitted to the hospital following the index hospitalization
30-days after hospital discharge date
Length of hospital stay
Time Frame: From enrollment through study completion, an average of 4 days
Number of days admitted to hospital
From enrollment through study completion, an average of 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heidi Lindroth, PhD, RN, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-005022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared with the NIDUS network and for other interested investigators. Please contact study team.

IPD Sharing Time Frame

November 1 2021-December 31 2023

IPD Sharing Access Criteria

Email investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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