Heart FailureNCT06051058
Care Transitions App for Patients With Multiple Chronic Conditions
A study testing Care Transitions App in people with Heart Failure and Congestive Heart Failure, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this study is to widely implement and evaluate the Care Transitions App in a randomized controlled trial. The app the investigators designed for patients with multiple chronic conditions has four envisioned modules: 1) falls-reduction content, 2) a digital post-discharge transitional care plan (e.g.… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Congestive Heart Failure, Diabetes
- What is being tested?
- Care Transitions App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 798 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (55+) with a Brigham PCP or appointment in one of the 15 locations discharging from a BWH general medicine unit
- Discharging to home, home health care service or assisted living
- Fluent in spoken English in patient or healthcare proxy
- Patients with at least one of the conditions listed below + one additional chronic condition on the problem list.
- Patient with heart failure on the problem list
- Patient with type 2 diabetes on the problem list
- Patient with chronic kidney disease on the problem list
Who cannot join
- Adult patients (55+) with Westwood, Pembroke, or Transition Clinic PCP admitted to ICU, OBGYN, Surgical, Cardiology, Oncology, Orthopedics, or other Specialty Unit
- Pregnant
- Prisoner, institutionalized individual or in police custody
- Discharge planned within 3 hours of screening
- Patient too ill to participate or with active psychosis/serious mental illness, delirium, or severe dementia
- Not fluent in spoken English in patient and health proxy
Show all 9Show fewer
- Unlikely to be discharged to home
- Lacks a device capable of accessing the app
- Lack of a working telephone for 30-day follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02120
Lipika Samal, lsamal@bwh.harvard.edu
About this study
The objective of this study is to widely implement and evaluate the Care Transitions App in a randomized controlled trial. The app the investigators designed for patients with multiple chronic conditions has four envisioned modules: 1) falls-reduction content, 2) a digital post-discharge transitional care plan (e.g., after hospital care plan, including education, medications, follow-up appointments, warning signs to watch for, nutrition, and other care plan activities), 3) a new module for patients with MCC (diabetes, congestive heart failure, and chronic kidney disease) including condition-specific post-discharge care plans with relevant symptom management activities, 4) a new post-discharge report module which summarizes key care transition findings and allows for patients to enter notes and questions for their providers and their own goals for recovery.
Read the detailed description
Care transitions are a vulnerable period for patients, leading to a 20% rate of readmissions, 11% rate of post-discharge adverse drug events, 15% rate of falls, and 29% rate of total post-discharge adverse events. Hospital discharge for patients with multiple chronic conditions (MCC) is a challenge for the hospital care teams, primary care providers (PCPs) and patients/caregivers who face the challenge of complex medication regimens, as well as patient-specific challenges in fall prevention strategies. Specific challenges include poor communication among inpatient providers, patients, and ambulatory providers, poor quality and timeliness of discharge documentation, suboptimal patient understanding of post-discharge plans of care and their ability to carry out these plans, medication discrepancies and non-adherence after discharge, failure to follow up the results of tests pending at time of discharge, failure to schedule necessary ambulatory appointments, tests, and procedures, and lack of timely follow-up with ambulatory providers.
These risks are especially important for people living with multiple chronic conditions (PLWMCC), such as diabetes (DM), congestive heart failure (CHF), and chronic kidney disease (CKD). Each of these conditions requires a complex medication regimen which is often altered during the hospital admission. Often, the medications cannot be changed back to their original dose at the time of discharge because patients are eating less than usual, have become dehydrated, and their kidney function has been affected by nephrotoxic medications. Clearance of medications such as insulin is also altered and limited physical activity in the hospital places patients at increased risk for falls after discharge. All of these factors increase the risk of adverse events in the post-discharge period. An overarching goal of the intervention is to overcome common care transition challenges by simplifying the information patients and caregivers receive and empowering them to carry out their care plans.
Previous research supports the use of mobile apps for improving health outcomes among those living with chronic illness. While many apps are available for chronic disease management, most of them focus on a single chronic illness such as diabetes or heart failure, or self-management area such as medication management, sleep, or pain and do not specifically target the period of transition from hospital to home. The intervention will fill an existing gap by developing, rigorously testing, and disseminating a comprehensive Care Transitions App for patients with MCC that will provide comprehensive care transition information for disease self-management, medication safety, and fall prevention in a format that is simple and actionable.
The investigators will conduct a pragmatic randomized controlled trial in an academic medical center (Brigham and Women's Hospital) and primary care clinics to test the effectiveness of the Care Transitions App enrolling patients age 55 or older with MCC including Diabetes, congestive heart failure, and/or chronic kidney disease.
- Conditions
- Heart Failure, Congestive Heart Failure, Diabetes, Diabetes Mellitus, Chronic Kidney Diseases
- Being tested
- Care Transitions App
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Transitions AppBehavioural
Patients in the intervention arm will be randomized to receive the Care Transitions App and utilize it to support their care transition care plan for multiple chronic conditions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Care Transitions App | Experimental | Use of the Care Transitions App to support the care transition for patients hospitalized and discharged with multiple chronic conditions will be compared to usual care. Receives: Behavioral: Care Transitions App |
| No Intervention: Usual Care | No intervention | Usual care transition care for patients hospitalized and discharged with multiple chronic conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of the Care Transitions App on post-discharge adverse events
Overall rate of post-discharge adverse events
Measured: 30 Days
Secondary outcomes (1)
To determine the effect of the Care Transitions App on the 30-day readmission rate
30-day readmission rate
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start8 Oct 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a randomized trial with patients recruited inpatient from Brigham and Women's Hospital and nested within primary care practices in the MGB healthcare system. The unit of randomization is the patient.
- Masking
- None (open label)
- Enrolment
- 798 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Lipika Samal, Brigham and Women's Hospital
- Investigators
- Lipika Samal, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051058
- Sponsor's protocol ID
- 2023P001447
- Status last verified
- Jul 2026
- First submitted
- 18 Sep 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Transitions App for Patients With Multiple Chronic Conditions
- ClinicalTrials.gov ID
- NCT06051058
- Acronym / sponsor ID
- 2023P001447
- Conditions
- Heart Failure, Congestive Heart Failure, Diabetes, Diabetes Mellitus, Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 798 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Sep 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 objective of this study is to widely implement and evaluate the Care Transitions App in a randomized controlled trial. The app the investigators designed for patients with multiple chronic conditions has four envisioned modules: 1) falls-reduction content, 2) a digital post-discharge transitional care plan (e.g., after hospital care plan, including education, medications, follow-up appointments, warning signs to watch for, nutrition, and other care plan activities), 3) a new module for patients with MCC (diabetes, congestive heart failure, and chronic kidney disease) including condition-specific post-discharge care plans with relevant symptom management activities, 4) a new post-discharge report module which summarizes key care transition findings and allows for patients to enter notes and questions for their providers and their own goals for recovery.
Detailed description
Care transitions are a vulnerable period for patients, leading to a 20% rate of readmissions, 11% rate of post-discharge adverse drug events, 15% rate of falls, and 29% rate of total post-discharge adverse events. Hospital discharge for patients with multiple chronic conditions (MCC) is a challenge for the hospital care teams, primary care providers (PCPs) and patients/caregivers who face the challenge of complex medication regimens, as well as patient-specific challenges in fall prevention strategies. Specific challenges include poor communication among inpatient providers, patients, and ambulatory providers, poor quality and timeliness of discharge documentation, suboptimal patient understanding of post-discharge plans of care and their ability to carry out these plans, medication discrepancies and non-adherence after discharge, failure to follow up the results of tests pending at time of discharge, failure to schedule necessary ambulatory appointments, tests, and procedures, and lack of timely follow-up with ambulatory providers.
These risks are especially important for people living with multiple chronic conditions (PLWMCC), such as diabetes (DM), congestive heart failure (CHF), and chronic kidney disease (CKD). Each of these conditions requires a complex medication regimen which is often altered during the hospital admission. Often, the medications cannot be changed back to their original dose at the time of discharge because patients are eating less than usual, have become dehydrated, and their kidney function has been affected by nephrotoxic medications. Clearance of medications such as insulin is also altered and limited physical activity in the hospital places patients at increased risk for falls after discharge. All of these factors increase the risk of adverse events in the post-discharge period. An overarching goal of the intervention is to overcome common care transition challenges by simplifying the information patients and caregivers receive and empowering them to carry out their care plans.
Previous research supports the use of mobile apps for improving health outcomes among those living with chronic illness. While many apps are available for chronic disease management, most of them focus on a single chronic illness such as diabetes or heart failure, or self-management area such as medication management, sleep, or pain and do not specifically target the period of transition from hospital to home. The intervention will fill an existing gap by developing, rigorously testing, and disseminating a comprehensive Care Transitions App for patients with MCC that will provide comprehensive care transition information for disease self-management, medication safety, and fall prevention in a format that is simple and actionable.
The investigators will conduct a pragmatic randomized controlled trial in an academic medical center (Brigham and Women's Hospital) and primary care clinics to test the effectiveness of the Care Transitions App enrolling patients age 55 or older with MCC including Diabetes, congestive heart failure, and/or chronic kidney disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The design is a randomized trial with patients recruited inpatient from Brigham and Women's Hospital and nested within primary care practices in the MGB healthcare system. The unit of randomization is the patient.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Care Transitions App | Experimental | Behavioral: Care Transitions AppUse of the Care Transitions App to support the care transition for patients hospitalized and discharged with multiple chronic conditions will be compared to usual care. |
| No Intervention: Usual Care | No intervention | –Usual care transition care for patients hospitalized and discharged with multiple chronic conditions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients (55+) with a Brigham PCP or appointment in one of the 15 locations discharging from a BWH general medicine unit
- Discharging to home, home health care service or assisted living
- Fluent in spoken English in patient or healthcare proxy
- Patients with at least one of the conditions listed below + one additional chronic condition on the problem list.
- Patient with heart failure on the problem list
Key exclusion criteria (9 listed)
- Adult patients (55+) with Westwood, Pembroke, or Transition Clinic PCP admitted to ICU, OBGYN, Surgical, Cardiology, Oncology, Orthopedics, or other Specialty Unit
- Pregnant
- Prisoner, institutionalized individual or in police custody
- Discharge planned within 3 hours of screening
- Patient too ill to participate or with active psychosis/serious mental illness, delirium, or severe dementia
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 |
|---|---|---|
| Care Transitions AppPatients in the intervention arm will be randomized to receive the Care Transitions App and utilize it to support their care transition care plan for multiple chronic conditions. | Behavioural | Experimental: Care Transitions App |
Primary outcome
To determine the effect of the Care Transitions App on post-discharge adverse events
Time frame: 30 Days
Overall rate of post-discharge adverse events
1 secondary outcome
To determine the effect of the Care Transitions App on the 30-day readmission rate
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Lipika Samal, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Transitions App in people with Heart Failure and Congestive Heart Failure, run by Brigham and Women's Hospital 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lipika Samal, MD, MPH (617-732-7063, lsamal@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of the Care Transitions App on post-discharge adverse events (time frame: 30 Days). 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 9 Jul 2026.