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

March 18, 2024 updated by: Laguna Health, Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed to provide support to a select group of participants by supplementing the hospital-provided discharge instructions. Laguna integrated hospital provided clinical guidance and Laguna's personalized contextual care protocols, with the goal of improving health outcomes and reducing readmissions within 90 days post-discharge.

Particiants in the intervention group received support from Laguna Health via Laguna's mobile app, phone, video, text, or web chat. Laguna provided contextual support to remove recovery barriers to these intervention participants.

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • 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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Group received support from Laguna Coaches
Behavioral: Laguna Coach and App Intervention Group
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.
No Intervention: Control Arm
Group received no support from Laguna Coaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unplanned All Cause Readmission Rate
Time Frame: 90 Days Post-Discharge
90 Days Post-Discharge

Collaborators and Investigators

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

Sponsor

Laguna Health, Inc

Collaborators

Mayo Clinic

Investigators

  • Principal Investigator: Thomas P Olson, Ph.D., M.S., Mayo Clinic

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)

November 15, 2021

Primary Completion (Actual)

October 5, 2023

Study Completion (Actual)

December 29, 2023

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-003810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD

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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