The Impact of a Personalized Care Intervention on 90-day Post-Discharge Care

NCT06146582 | Completed DMC

• 1 other identifier: 21-003810
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this 90 day study is to demonstrate the extent to which participants with cardiovascular conditions can improve their recovery at home through a mobile app, support and resources made available to them after hospitalization. The study will evaluate the effectiveness of personal care intervention support, including one-on-one guidance, educational information, check-ins, and Laguna's mobile app to help participants recover better after hospitalization.

Conditions

Cardiovascular Diseases

Keywords

Readmissions; Behavioral Health; Care Transitions; Social Determinants of Health; Contextualizing Healthcare; Virtual Coaching

Outcome Measures

Primary Outcomes (1)

• Unplanned All Cause Readmission Rate

  90 Days Post-Discharge

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Group received support from Laguna Coaches

Behavioral: Laguna Coach and App Intervention Group

Control Arm

NO INTERVENTION

Group received no support from Laguna Coaches

Interventions

Laguna Coach and App Intervention Group BEHAVIORAL

Behavioral, mental and contextual support was delivered through personal interactions with Laguna Coaches via mobile app, phone, video, or web chat. Care interventions were individualized to best match each participant's needs and strengths. Support will be provided to participants through interactions over approximately 90 days.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the hospital with a diagnosis of a cardiovascular disorder as defined by the coded diagnoses for that admission
• Discharged to home
• Converse in English
• Uses a telephone (landline or cell phone)

You may not qualify if:

• Participant unable to provide informed consent
• Participant lacks cognitive ability to participate in the study interventions as judged by the individual initiating the consenting process

Sponsors & Collaborators

• Laguna Health, Inc: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Thomas P Olson, Ph.D., M.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were assigned upon consent randomly to an intervention or control group. The intervention group received support from Laguna Coaches and Laguna's mobile app for 90 days, the control group did not receive any support from Laguna coaches or Laguna's app.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: November 15, 2021
• Primary Completion: October 5, 2023
• Study Completion: December 29, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)