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

NCT ID: NCT05118867

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2027-12-31

Brief 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.

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

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

iPREPARED

Intervention Type: BEHAVIORAL

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.

Standard Hospital Care Group

Participants will receive standard protocolized care procedures.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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)

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

• Unable or unwilling to participate due to language barriers, availability, or other communication barriers

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Heidi L. Lindroth PhD RN

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heidi Lindroth, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

21-005022

Identifier Type: -

Identifier Source: org_study_id