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

NCT05118867 | Suspended

• 1 other identifier: 21-005022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Feasibility of study recruitment to intervention 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

  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

  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 Outcomes (9)

• Delirium-related distress

  From enrollment through study completion, an average of 4 days

• Resiliency

  At enrollment into study

• General Self-Rated Health Status

  At enrollment into study

• Delirium Severity

  From enrollment through study completion, an average of 4 days

• Acute Stress associated with the hospitalization

  From enrollment through study completion, an average of 4 days

Study Arms (2)

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.

Behavioral: iPREPARED

Standard Hospital Care Group

NO INTERVENTION

Participants will receive standard protocolized care procedures.

Interventions

iPREPARED 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.

IPREPARED Hospital Recovery Club

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Delirium; Hearing Loss

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders

Study Officials

• Heidi Lindroth, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 12, 2021
• Study Start: December 16, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: November 1 2021-December 31 2023
• Access Criteria: Email investigator

Locations

US (1)