Heart FailureNCT04662541
Mobile Integrated Health in Heart Failure
A study testing Mobile Integrated Health (MIH) and Transitions of care coordinator (TOCC) in people with Heart Failure, run by Columbia University at 3 sites in United States.
Trial summary
The purpose of this study is to compare how two different types of care after a hospitalization reduce hospital readmissions and symptom burden. The two types of care are a Transitions of Care Coordinator and Mobile Integrated Health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Mobile Integrated Health (MIH) and Transitions of care coordinator (TOCC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,005 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Jan 2021to 1 Nov 2024
- 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
- Medicare or Medicaid recipient
- Current diagnosis of HF
- Receiving inpatient care at NewYork Presbyterian or Mount Sinai Health Systems
- Live in NYC
Who cannot join
- Non-English, Spanish, Mandarin, or French speaking
- Diagnosis of dementia or psychosis
- Anticipated discharge to, or current residence in, skilled nursing facility or rehab center
- Anticipated discharge to, or currently receiving, hospice including home hospice
- Current candidate for and awaiting heart transplant
- Current left ventricular assist device (LVAD)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mount Sinai Health System
New York, New York, 10029
Columbia University Irving Medical Center
New York, New York, 10032
New York Presbyterian/Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Using Mobile Integrated Health and Telehealth to Support Transitions of Care Among Heart Failure Patients - Parent Study
The purpose of this study is to compare how two different types of care after a hospitalization reduce hospital readmissions and symptom burden. The two types of care are a Transitions of Care Coordinator and Mobile Integrated Health. In the Transitions of Care Coordinator group, participants will receive a phone call from a care coordinator right after they go home following a hospitalization to check in. In the Mobile Integrated Health group, participants will be offered access to a community paramedic in case they need medical care while they are recovering at home after a hospitalization. The community paramedic will come to their home to perform an evaluation and set up a visit with an emergency physician via video conference. They may receive treatment at home or be transported to the emergency department. The investigators will be compare how well a Transitions of Care Coordinator and Mobile Integrated Health reduce readmissions to the hospital within 30 days of discharge and improve patient-reported health-related quality of life. The investigators hypothesize that participants in the Mobile Integrated Health group will have fewer readmissions to the hospital within 30 days of discharge and better health-related quality of life compared to participants in the Transitions of Care Coordinator group.
Read the detailed description
High 30-day readmission rates among heart failure (HF) patients (25% nationally) inflict substantial burden on both health systems and patients. The majority of hospital readmissions occur in the first seven days following a hospitalization for HF and are driven by lack of improvement in persistent symptoms. While early, proactive follow-up after hospital discharge can improve health outcomes and patient-reported quality of life, barriers within health systems (lack of appointment availability, transportation, limited ability to deliver medical therapies in the home) have hampered efforts to provide comprehensive follow-up. Evidence suggests that Mobile Integrated Health (MIH), involving community paramedicine coupled with telemedicine, may be an effective intervention to reduce readmissions. The long-term goal of this research is to provide rigorous evidence of MIH with a diverse, representative sample. In this pragmatic randomized clinical trial, the investigators will compare MIH to a Transitions of Care Coordinator (TOCC) intervention.
Specifically, the investigators aim to compare the effectiveness of MIH versus TOCC on healthcare utilization (aim 1), patient-reported outcomes (PROs; aim 2), and healthcare quality (aim 3). The investigators will also evaluate the factors that support the adoption, implementation, and maintenance from the perspective of multiple key stakeholders (aim 4). Participants in this RCT will be randomized 1:1 to either MIH (intervention) or TOCC (comparator). All participants will be enrolled and randomized during a hospitalization for HF. Participants in MIH will receive a follow-up phone call and access to community paramedics who provide a comprehensive assessment in the home, and specific medical therapies while consulting with an emergency room physician in real-time via telemedicine. Participants in TOCC will receive a follow-up phone call within 48-72 hours of discharge and connection to appropriate services (social work, care coordination, home care) as needed. Participants in both groups will complete PROs using a rigorously developed, visually enhanced mobile PRO reporting system.
The study population will include patients at NewYork-Presbyterian (NYP) and Mount Sinai health systems, which are part of the New York City-based INSIGHT PCORI-funded clinical research network. The targeted sample size across the two sites is 2,100 patients (1,050 per arm). This record is for the parent PCORI-funded trial evaluating MIH among HF patients. There is a separate sub-study being conducted locally at NYP which is described in another record.
- Conditions
- Heart Failure
- Being tested
- Mobile Integrated Health (MIH), Transitions of care coordinator (TOCC)
- Keywords
- Mobile Health, Mobile Integrated Health (MIH), Heart Failure (HF), mHealth
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Integrated Health (MIH)Other
MIH leverages paramedics in the community and telemedicine (technology-enabled communication for health purposes) to provide medical care to heart failure patients in the home.
Transitions of care coordinator (TOCC)Other
The TOCC group will receive a follow-up phone call shortly after discharge in which the patient is assessed and connected to clinical and social services as needed and patient education is reinforced.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Integrated Health (MIH) | Experimental | Patients with urgent medical needs are seen and treated in the home by trained community paramedics. The community paramedics perform a standardized assessment, including a physical examination, vital signs, home safety evaluation, and medication reconciliation. During the MIH encounter, the emergency medicine physician at each site is contacted via telemedicine. Physicians can access clinical notes, discharge summaries, and medication lists via the institutional EHR. Adjustments to outpatient medications can be e-prescribed and follow-up appointments can be scheduled with primary care clinicians. Receives: Other: Mobile Integrated Health (MIH) |
| Transitions of care coordinator (TOCC) | Active comparator | Patients receive a follow-up phone calls for a nurse coordinator within 48-72 hours of hospital discharge. Phone calls include clinical/social needs assessment with escalation to primary care team, emergency care, or social work as needed; patient education; and reminder about follow-up appointments. Receives: Other: Transitions of care coordinator (TOCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of all-cause hospital readmissions
Number of readmissions to the hospital for any reason following a hospitalization
Measured: 30 days
Patient-reported health-related quality of life score assessed using the KCCQ
Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning.
Measured: 30 days
Secondary outcomes (20)
Number of preventable emergency department visits
Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm
Measured: 30 days
Number of preventable emergency department visits
Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm
Measured: 60 days
Number of preventable emergency department visits
Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm
Measured: 90 days
Number of preventable emergency department visits
Number of emergency department visits following a hospitalization that are considered preventable according to a previously validated algorithm
Measured: 6 months
Number of unplanned hospital readmissions
Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm
Measured: 30 days
Number of unplanned hospital readmissions
Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm
Measured: 60 days
Number of unplanned hospital readmissions
Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm
Measured: 90 days
Number of unplanned hospital readmissions
Number of readmissions to the hospital following a hospitalization that are considered unplanned according to a validated algorithm
Measured: 6 months
Number of days at home
Number of days at home (alive and not in a hospital or other medical facility) following a hospitalization
Measured: 30 days
Patient-reported symptoms and functioning score assessed using PROMIS-29
Patient-reported symptoms and functioning score, measured using the Patient-Reported Outcomes Measurement Information System 29-item survey (PROMIS-29). PROMIS-29 domains are scored separately: physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, and pain interference. Each domain is scored using a standardized T-score ranging from approximately 20 to 80, with lower scores indicating less of the symptom (i.e., less fatigue), and higher scores indicating more of the symptom (i.e., more fatigue).
Measured: 30 days
Patient-reported symptoms and functioning score assessed using PROMIS-29
Patient-reported symptoms and functioning score, measured using the Patient-Reported Outcomes Measurement Information System 29-item survey (PROMIS-29). PROMIS-29 domains are scored separately: physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, and pain interference. Each domain is scored using a standardized T-score ranging from approximately 20 to 80, with lower scores indicating less of the symptom (i.e., less fatigue), and higher scores indicating more of the symptom (i.e., more fatigue).
Measured: 60 days
Patient-reported symptoms and functioning score assessed using PROMIS-29
Patient-reported symptoms and functioning score, measured using the Patient-Reported Outcomes Measurement Information System 29-item survey (PROMIS-29). PROMIS-29 domains are scored separately: physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with participation in social roles, and pain interference. Each domain is scored using a standardized T-score ranging from approximately 20 to 80, with lower scores indicating less of the symptom (i.e., less fatigue), and higher scores indicating more of the symptom (i.e., more fatigue).
Measured: 90 days
Patient self-care score assessed using the SCHFI
Patient self-care score assessed using the Self-Care of Heart Failure Index (SCHFI). SCHFI standardized scores are reported separately for each domain: self-care maintenance, self-care monitoring, and self-care management. Scores range from 0 to 100, with lower scores (closer to 0) representing worse self-care and higher scores (closer to 100) representing better self-care.
Measured: 30 days
Patient self-care score assessed using the SCHFI
Patient self-care score assessed using the Self-Care of Heart Failure Index (SCHFI). SCHFI standardized scores are reported separately for each domain: self-care maintenance, self-care monitoring, and self-care management. Scores range from 0 to 100, with lower scores (closer to 0) representing worse self-care and higher scores (closer to 100) representing better self-care.
Measured: 60 days
Patient self-care score assessed using the SCHFI
Patient self-care score assessed using the Self-Care of Heart Failure Index (SCHFI). SCHFI standardized scores are reported separately for each domain: self-care maintenance, self-care monitoring, and self-care management. Scores range from 0 to 100, with lower scores (closer to 0) representing worse self-care and higher scores (closer to 100) representing better self-care.
Measured: 90 days
Patient-reported health-related quality of life score assessed using the KCCQ
Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning.
Measured: 60 days
Patient-reported health-related quality of life score assessed using the KCCQ
Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning.
Measured: 90 days
Number of all-cause hospital readmissions
Number of readmissions to the hospital for any reason following a hospitalization
Measured: 60 days
Number of all-cause hospital readmissions
Number of readmissions to the hospital for any reason following a hospitalization
Measured: 90 days
Number of all-cause hospital readmissions
Number of readmissions to the hospital for any reason following a hospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start4 Jan 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 2,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Ruth Masterson Creber, Columbia University
- Investigators
- Ruth M. Masterson Creber, PhD, MSc, RN, Principal investigator, Columbia UniversityLeah Shafran Topaz, BPT, MSc, Study director, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662541
- Sponsor's protocol ID
- AAAU2716
- Other IDs
- IHS-2019C2-17373, 20-08022605-01
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2020
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masterson Creber R, Daniels B, Reading Turchioe M, Shafran Topaz L, Zhao Y, Choi J, Ellison M, Merchant RC, Blutinger E, Goyal P, Yu J, Weiner MG, Sholle E, Ramasubbu K, Alishetti S, Axsom K, Slotwiner D, Rao M, Diaz I, Spertus JA, Sharma R, Kaushal R. Mobile Integrated Health vs a Transitions of Care Coordinator for Patients Discharged After Heart Failure: The Mighty-Heart Randomized Clinical Trial. JAMA Intern Med. 2025 Nov 1;185(11):1341-1348. doi: 10.1001/jamainternmed.2025.4483.
PubMed 40952734Masterson Creber RM, Daniels B, Munjal K, Reading Turchioe M, Shafran Topaz L, Goytia C, Diaz I, Goyal P, Weiner M, Yu J, Khullar D, Slotwiner D, Ramasubbu K, Kaushal R. Using Mobile Integrated Health and telehealth to support transitions of care among patients with heart failure (MIGHTy-Heart): protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Mar 10;12(3):e054956. doi: 10.1136/bmjopen-2021-054956.
PubMed 35273051
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Mobile Integrated Health and Telehealth to Support Transitions of Care Among Heart Failure Patients - Parent Study
- ClinicalTrials.gov ID
- NCT04662541
- Acronym / sponsor ID
- AAAU2716
- Conditions
- Heart Failure
- Keywords
- Mobile Health, Mobile Integrated Health (MIH), Heart Failure (HF), mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,005 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 10 Dec 2020 (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 study is to compare how two different types of care after a hospitalization reduce hospital readmissions and symptom burden. The two types of care are a Transitions of Care Coordinator and Mobile Integrated Health. In the Transitions of Care Coordinator group, participants will receive a phone call from a care coordinator right after they go home following a hospitalization to check in. In the Mobile Integrated Health group, participants will be offered access to a community paramedic in case they need medical care while they are recovering at home after a hospitalization. The community paramedic will come to their home to perform an evaluation and set up a visit with an emergency physician via video conference. They may receive treatment at home or be transported to the emergency department. The investigators will be compare how well a Transitions of Care Coordinator and Mobile Integrated Health reduce readmissions to the hospital within 30 days of discharge and improve patient-reported health-related quality of life. The investigators hypothesize that participants in the Mobile Integrated Health group will have fewer readmissions to the hospital within 30 days of discharge and better health-related quality of life compared to participants in the Transitions of Care Coordinator group.
Detailed description
High 30-day readmission rates among heart failure (HF) patients (25% nationally) inflict substantial burden on both health systems and patients. The majority of hospital readmissions occur in the first seven days following a hospitalization for HF and are driven by lack of improvement in persistent symptoms. While early, proactive follow-up after hospital discharge can improve health outcomes and patient-reported quality of life, barriers within health systems (lack of appointment availability, transportation, limited ability to deliver medical therapies in the home) have hampered efforts to provide comprehensive follow-up. Evidence suggests that Mobile Integrated Health (MIH), involving community paramedicine coupled with telemedicine, may be an effective intervention to reduce readmissions. The long-term goal of this research is to provide rigorous evidence of MIH with a diverse, representative sample. In this pragmatic randomized clinical trial, the investigators will compare MIH to a Transitions of Care Coordinator (TOCC) intervention.
Specifically, the investigators aim to compare the effectiveness of MIH versus TOCC on healthcare utilization (aim 1), patient-reported outcomes (PROs; aim 2), and healthcare quality (aim 3). The investigators will also evaluate the factors that support the adoption, implementation, and maintenance from the perspective of multiple key stakeholders (aim 4). Participants in this RCT will be randomized 1:1 to either MIH (intervention) or TOCC (comparator). All participants will be enrolled and randomized during a hospitalization for HF. Participants in MIH will receive a follow-up phone call and access to community paramedics who provide a comprehensive assessment in the home, and specific medical therapies while consulting with an emergency room physician in real-time via telemedicine. Participants in TOCC will receive a follow-up phone call within 48-72 hours of discharge and connection to appropriate services (social work, care coordination, home care) as needed. Participants in both groups will complete PROs using a rigorously developed, visually enhanced mobile PRO reporting system.
The study population will include patients at NewYork-Presbyterian (NYP) and Mount Sinai health systems, which are part of the New York City-based INSIGHT PCORI-funded clinical research network. The targeted sample size across the two sites is 2,100 patients (1,050 per arm). This record is for the parent PCORI-funded trial evaluating MIH among HF patients. There is a separate sub-study being conducted locally at NYP which is described in another record.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Integrated Health (MIH) | Experimental | Other: Mobile Integrated Health (MIH)Patients with urgent medical needs are seen and treated in the home by trained community paramedics. The community paramedics perform a standardized assessment, including a physical examination, vital signs, home safety evaluation, and medication reconciliation. During the MIH encounter, the emergency medicine physician at each site is contacted via telemedicine. Physicians can access clinical notes, discharge summaries, and medication lists via the institutional EHR. Adjustments to outpatient medications can be e-prescribed and follow-up appointments can be scheduled with primary care clinicians. |
| Transitions of care coordinator (TOCC) | Active comparator | Other: Transitions of care coordinator (TOCC)Patients receive a follow-up phone calls for a nurse coordinator within 48-72 hours of hospital discharge. Phone calls include clinical/social needs assessment with escalation to primary care team, emergency care, or social work as needed; patient education; and reminder about follow-up appointments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medicare or Medicaid recipient
- Current diagnosis of HF
- Receiving inpatient care at NewYork Presbyterian or Mount Sinai Health Systems
- Live in NYC
Key exclusion criteria (6 listed)
- Non-English, Spanish, Mandarin, or French speaking
- Diagnosis of dementia or psychosis
- Anticipated discharge to, or current residence in, skilled nursing facility or rehab center
- Anticipated discharge to, or currently receiving, hospice including home hospice
- Current candidate for and awaiting heart transplant
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 |
|---|---|---|
| Mobile Integrated Health (MIH)MIH leverages paramedics in the community and telemedicine (technology-enabled communication for health purposes) to provide medical care to heart failure patients in the home. | Other | Mobile Integrated Health (MIH) |
| Transitions of care coordinator (TOCC)The TOCC group will receive a follow-up phone call shortly after discharge in which the patient is assessed and connected to clinical and social services as needed and patient education is reinforced. | Other | Transitions of care coordinator (TOCC) |
Primary outcome
Number of all-cause hospital readmissions
Time frame: 30 days
Number of readmissions to the hospital for any reason following a hospitalization
Patient-reported health-related quality of life score assessed using the KCCQ
Time frame: 30 days
Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning.
20 secondary outcomes
Number of preventable emergency department visits
Time frame: 30 days
Number of preventable emergency department visits
Time frame: 60 days
Number of preventable emergency department visits
Time frame: 90 days
Number of preventable emergency department visits
Time frame: 6 months
Number of unplanned hospital readmissions
Time frame: 30 days
Number of unplanned hospital readmissions
Time frame: 60 days
Number of unplanned hospital readmissions
Time frame: 90 days
Number of unplanned hospital readmissions
Time frame: 6 months
Number of days at home
Time frame: 30 days
Patient-reported symptoms and functioning score assessed using PROMIS-29
Time frame: 30 days
Patient-reported symptoms and functioning score assessed using PROMIS-29
Time frame: 60 days
Patient-reported symptoms and functioning score assessed using PROMIS-29
Time frame: 90 days
Patient self-care score assessed using the SCHFI
Time frame: 30 days
Patient self-care score assessed using the SCHFI
Time frame: 60 days
Patient self-care score assessed using the SCHFI
Time frame: 90 days
Patient-reported health-related quality of life score assessed using the KCCQ
Time frame: 60 days
Patient-reported health-related quality of life score assessed using the KCCQ
Time frame: 90 days
Number of all-cause hospital readmissions
Time frame: 60 days
Number of all-cause hospital readmissions
Time frame: 90 days
Number of all-cause hospital readmissions
Time frame: 6 months
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 19 Feb 2026.
- Derived from this study: PubMed 40952734Masterson Creber R, Daniels B, Reading Turchioe M, Shafran Topaz L, Zhao Y, Choi J, Ellison M, Merchant RC, Blutinger E, Goyal P, Yu J, Weiner MG, Sholle E, Ramasubbu K, Alishetti S, Axsom K, Slotwiner D, Rao M, Diaz I, Spertus JA, Sharma R, Kaushal R. Mobile Integrated Health vs a Transitions of Care Coordinator for Patients Discharged After Heart Failure: The Mighty-Heart Randomized Clinical Trial. JAMA Intern Med. 2025 Nov 1;185(11):1341-1348. doi: 10.1001/jamainternmed.2025.4483.
- Derived from this study: PubMed 35273051Masterson Creber RM, Daniels B, Munjal K, Reading Turchioe M, Shafran Topaz L, Goytia C, Diaz I, Goyal P, Weiner M, Yu J, Khullar D, Slotwiner D, Ramasubbu K, Kaushal R. Using Mobile Integrated Health and telehealth to support transitions of care among patients with heart failure (MIGHTy-Heart): protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Mar 10;12(3):e054956. doi: 10.1136/bmjopen-2021-054956.
- Individual participant dataSharing planned: No
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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.
Ruth M. Masterson Creber, PhD, MSc, RN principal investigator
Columbia University
Leah Shafran Topaz, BPT, MSc study director
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Integrated Health (MIH) and Transitions of care coordinator (TOCC) in people with Heart Failure, run by Columbia University at 3 sites 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 6 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Number of all-cause hospital readmissions (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662541, which also lists 2 linked publications.
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 19 Feb 2026.