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

Sponsor

Laguna Health, Inc (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06146582

Collaborator

Mayo Clinic (Other)

187

Enrollment

Location

Arms

25.5

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Readmissions in Cardiovascular Disorders	Behavioral: Laguna Coach and App Intervention Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

187 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 15, 2021

Actual Primary Completion Date :

Oct 5, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Unplanned All Cause Readmission Rate [90 Days Post-Discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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