Cardiovascular DiseasesNCT06146582
The Impact of a Personalized Care Intervention on 90-day Post-Discharge Care
A study testing Laguna Coach and App Intervention Group in people with Cardiovascular Diseases, run by Laguna Health, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Laguna Coach and App Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Laguna Coach and App Intervention Group
- Keywords
- Readmissions, Behavioral Health, Care Transitions, Social Determinants of Health, Contextualizing Healthcare, Virtual Coaching
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laguna Coach and App Intervention GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Group received support from Laguna Coaches Receives: Behavioral: Laguna Coach and App Intervention Group |
| Control Arm | No intervention | Group received no support from Laguna Coaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned All Cause Readmission Rate
Measured: 90 Days Post-Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start15 Nov 2021
- Primary completion5 Oct 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laguna Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Thomas P Olson, Ph.D., M.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146582
- Sponsor's protocol ID
- 21-003810
- Status last verified
- Mar 2024
- First submitted
- 17 Nov 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Personalized Care Intervention on 90-day Post-Discharge Care
- ClinicalTrials.gov ID
- NCT06146582
- Acronym / sponsor ID
- 21-003810
- Conditions
- Cardiovascular Diseases
- Keywords
- Readmissions, Behavioral Health, Care Transitions, Social Determinants of Health, Contextualizing Healthcare, Virtual Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Laguna Health, IncIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Laguna Coach and App Intervention GroupGroup received support from Laguna Coaches |
| Control Arm | No intervention | –Group received no support from Laguna Coaches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laguna Coach and App Intervention GroupBehavioral, 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. | Behavioural | Intervention Arm |
Primary outcome
Unplanned All Cause Readmission Rate
Time frame: 90 Days Post-Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas P Olson, Ph.D., M.S. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laguna Coach and App Intervention Group in people with Cardiovascular Diseases, run by Laguna Health, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned All Cause Readmission Rate (time frame: 90 Days Post-Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.