Heart Failure，CongestiveNCT05130008
Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure
A study testing Digitally-enabled CHW Care and Usual CHW Care in people with Heart Failure，Congestive, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- Digitally-enabled CHW Care and Usual CHW Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- HF diagnosis
- English proficiency
- Residence within 30 miles of MGH
- Being cared for by a cardiologist or primary care provider who manages their HF
- Current use and ownership of a smart phone
Who cannot join
- Cognitive deficits that prevent digital or human engagement
- Lack of health insurance
- Invoked health proxy or guardianship status
- History of smart phone use
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial.
Read the detailed description
Heart failure (HF) is a highly prevalent disease in the United States, with elevated morbidity and mortality. Nearly 6.2 million people in the US are affected by HF and this number is expected to rise to 8.5 million by 2030. Total direct medical costs of HF, mostly generated by inpatient hospitalizations, are estimated to increase from $21 billion in 2012 to $53 billion by 2030. HF is the leading cause of 30-day readmissions in the US; a quarter of these are considered to be preventable. Most patients with HF are readmitted to hospital medicine services for non-HF co-morbidities (e.g. pneumonia) with clinical, social, and behavioral factors driving readmissions. Despite numerous interventions designed to prevent readmissions, including telemetry monitoring, only marginal HF outcome improvement has been observed. HF readmission rates remain elevated and could be prevented by a multidisciplinary approach promoting better connections to and communication with clinical care teams while addressing social and behavioral barriers to HF care.
One approach that has demonstrated improved chronic disease outcomes by addressing social, behavioral, and basic clinical barriers to care- and has yet to be formally studied in HF populations- is community health workers (CHWs). CHWs are members of clinical teams who address social, economic, educational, behavioral, and basic clinical factors influencing health outcomes while fostering patient connections to care teams. CHW care delivery is one of a few interventions shown to reduce readmissions in patients with chronic disease. CHWs have basic clinical knowledge of specific conditions, along with a skillset designed to address social and behavioral drivers of health outcomes like 30-day readmissions. However, CHW care is challenged by key factors, including intensive 1:1 care delivery, limiting its scale and efficiency.
In 2016, a biotechnology company launched a HF digital platform within a mobile phone application to help reduce 30-day readmissions in patients with HF by 1) leveraging artificial intelligence to minimize false alarms in biometric monitoring, 2) promoting early identification of decline in HF patients, and 3) encouraging digital and in-person communication between patients and care teams. In preliminary findings, digital platform clinical trial data has shown promise in reducing HF 30-day readmissions. This study will investigate the effectiveness of this platform in combination with CHW care in reducing readmissions for medically and socially complex patients with HF. Through a partnership with the digital platform creators, our team has helped develop a prototype for patients with HF cared for by CHWs ("digitally-enabled" CHW care). Specifically, the aim of this proposal are to assess the acceptability, feasibility, and preliminary effectiveness of implementing a digitally-enabled CHW intervention compared to CHW care to reduce HF 30-day readmissions within a pilot RCT (n=50) My central hypothesis is that pairing patients with a digitally-enabled CHW intervention that addresses social and behavioral barriers to HF care, promotes communication with clinical care teams, and improves CHW efficiency will reduce 30-day readmissions while improving patient engagement with HF care.
- Conditions
- Heart Failure，Congestive
- Being tested
- Digitally-enabled CHW Care, Usual CHW Care
- Keywords
- community health worker care, digital platform, remote monitoring, readmissions, clinical trial, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally-enabled CHW CareOther
Patients will be paired with a CHW and be encouraged to wear the arm biosensor continuously, take blood pressure daily, respond to short symptom assessments daily or every other day, complete weekly life quality surveys, watch weekly HF educational videos and engage in digital (e.g., video visit) and phone-based, and in-person CHW interactions. Each participant will have access to the digital platform and CHW staff during their hospitalization and for the 30 days following discharge for a typical study duration of approximately 32-35 days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.
Usual CHW CareBehavioural
Patients will be paired with a CHW for 30-days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients identified by the MGH readmission database and the EHR as eligible for the study will be enrolled. Participants will be paired with a community health worker and oriented to the digital platform ( mobile app, digital weight scale, digital blood pressure monitor, biosensor with armband). Participants will have access to the community health worker and the digital platform throughout the 30-day study interval. Receives: Other: Digitally-enabled CHW Care |
| Usual CHW Care | Active comparator | Patients identified by the MGH readmission database and the EHR as eligible for the study will be enrolled. Participants will be paired with a community health worker. Participants will have access to the community health worker throughout the 30-day study interval. Receives: Behavioral: Usual CHW Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
Proportion of patients indicating that they would be willing to use the intervention again
Measured: 30 days
Intervention Feasibility
Proportion of patients that used the intervention during the study period
Measured: 30 days
Secondary outcomes (4)
30-day Readmission Rate
Proportion of patients readmitted to the hospital within 30-days after hospital discharge
Measured: 30 days
30-day Missed Appointment Rate
Proportion of patients missing PCP or specialty appointments within 30-days after hospital discharge
Measured: 30 days
30-day Emergency Department Visit Rate
Proportion of patients returning to the Emergency Department within 30-days of hospital discharge
Measured: 30 days
Heart Failure Knowledge (Associated With a Subset of Participants Assessed for This Measure Prior to Being Randomized to the Intervention or Control Arm)
Proportion of patients perceiving their heart failure knowledge as very good or good (per an internally validated knowledge questionnaire; very good, good, fair, poor)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start23 Sep 2022
- Primary completion1 Jun 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jocelyn Carter, Massachusetts General Hospital
- Investigators
- Jocelyn Carter, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130008
- Sponsor's protocol ID
- 2018P002014
- Other IDs
- 1K23HL150287-01
- Status last verified
- Apr 2025
- First submitted
- 10 Nov 2021
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data can be available by request only after academic journal publication. Any formal requests should be sent by external research teams and will be reviewed by the corresponding author.
Publications
Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
PubMed 23616602McHugh MD, Ma C. Hospital nursing and 30-day readmissions among Medicare patients with heart failure, acute myocardial infarction, and pneumonia. Med Care. 2013 Jan;51(1):52-9. doi: 10.1097/MLR.0b013e3182763284.
PubMed 23151591Abdel-All M, Putica B, Praveen D, Abimbola S, Joshi R. Effectiveness of community health worker training programmes for cardiovascular disease management in low-income and middle-income countries: a systematic review. BMJ Open. 2017 Nov 3;7(11):e015529. doi: 10.1136/bmjopen-2016-015529.
PubMed 29101131Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27.
PubMed 29703724Carter JAC, Swack N, Isselbacher E, Donelan K, Thorndike A. Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Pilot Randomized Controlled Trial. JMIR Cardio. 2024 Aug 8;8:e59948. doi: 10.2196/59948.
PubMed 38959294Carter J, Swack N, Isselbacher E, Donelan K, Thorndike A. Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 6;13:e55687. doi: 10.2196/55687.
PubMed 38216543
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT05130008
- Acronym / sponsor ID
- 2018P002014
- Conditions
- Heart Failure，Congestive
- Keywords
- community health worker care, digital platform, remote monitoring, readmissions, clinical trial, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Posted 20 Apr 2025
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 assess the acceptability, feasibility, and preliminary effectiveness of implementing a 30-day digitally-enabled community health worker intervention compared to usual care with a community health worker in reducing heart failure 30-day readmissions within a pilot randomized controlled trial.
Detailed description
Heart failure (HF) is a highly prevalent disease in the United States, with elevated morbidity and mortality. Nearly 6.2 million people in the US are affected by HF and this number is expected to rise to 8.5 million by 2030. Total direct medical costs of HF, mostly generated by inpatient hospitalizations, are estimated to increase from $21 billion in 2012 to $53 billion by 2030. HF is the leading cause of 30-day readmissions in the US; a quarter of these are considered to be preventable. Most patients with HF are readmitted to hospital medicine services for non-HF co-morbidities (e.g. pneumonia) with clinical, social, and behavioral factors driving readmissions. Despite numerous interventions designed to prevent readmissions, including telemetry monitoring, only marginal HF outcome improvement has been observed. HF readmission rates remain elevated and could be prevented by a multidisciplinary approach promoting better connections to and communication with clinical care teams while addressing social and behavioral barriers to HF care.
One approach that has demonstrated improved chronic disease outcomes by addressing social, behavioral, and basic clinical barriers to care- and has yet to be formally studied in HF populations- is community health workers (CHWs). CHWs are members of clinical teams who address social, economic, educational, behavioral, and basic clinical factors influencing health outcomes while fostering patient connections to care teams. CHW care delivery is one of a few interventions shown to reduce readmissions in patients with chronic disease. CHWs have basic clinical knowledge of specific conditions, along with a skillset designed to address social and behavioral drivers of health outcomes like 30-day readmissions. However, CHW care is challenged by key factors, including intensive 1:1 care delivery, limiting its scale and efficiency.
In 2016, a biotechnology company launched a HF digital platform within a mobile phone application to help reduce 30-day readmissions in patients with HF by 1) leveraging artificial intelligence to minimize false alarms in biometric monitoring, 2) promoting early identification of decline in HF patients, and 3) encouraging digital and in-person communication between patients and care teams. In preliminary findings, digital platform clinical trial data has shown promise in reducing HF 30-day readmissions. This study will investigate the effectiveness of this platform in combination with CHW care in reducing readmissions for medically and socially complex patients with HF. Through a partnership with the digital platform creators, our team has helped develop a prototype for patients with HF cared for by CHWs ("digitally-enabled" CHW care). Specifically, the aim of this proposal are to assess the acceptability, feasibility, and preliminary effectiveness of implementing a digitally-enabled CHW intervention compared to CHW care to reduce HF 30-day readmissions within a pilot RCT (n=50) My central hypothesis is that pairing patients with a digitally-enabled CHW intervention that addresses social and behavioral barriers to HF care, promotes communication with clinical care teams, and improves CHW efficiency will reduce 30-day readmissions while improving patient engagement with HF care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Digitally-enabled CHW CarePatients identified by the MGH readmission database and the EHR as eligible for the study will be enrolled. Participants will be paired with a community health worker and oriented to the digital platform ( mobile app, digital weight scale, digital blood pressure monitor, biosensor with armband). Participants will have access to the community health worker and the digital platform throughout the 30-day study interval. |
| Usual CHW Care | Active comparator | Behavioral: Usual CHW CarePatients identified by the MGH readmission database and the EHR as eligible for the study will be enrolled. Participants will be paired with a community health worker. Participants will have access to the community health worker throughout the 30-day study interval. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- HF diagnosis
- English proficiency
- Residence within 30 miles of MGH
- Being cared for by a cardiologist or primary care provider who manages their HF
Key exclusion criteria (4 listed)
- Cognitive deficits that prevent digital or human engagement
- Lack of health insurance
- Invoked health proxy or guardianship status
- History of smart phone use
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 |
|---|---|---|
| Digitally-enabled CHW CarePatients will be paired with a CHW and be encouraged to wear the arm biosensor continuously, take blood pressure daily, respond to short symptom assessments daily or every other day, complete weekly life quality surveys, watch weekly HF educational videos and engage in digital (e.g., video visit) and phone-based, and in-person CHW interactions. Each participant will have access to the digital platform and CHW staff during their hospitalization and for the 30 days following discharge for a typical study duration of approximately 32-35 days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends. | Other | Intervention |
| Usual CHW CarePatients will be paired with a CHW for 30-days. Participants will complete questionnaires at the time of enrollment and at study end. Participants will also complete exit interviews in-person or via phone after the study ends. | Behavioural | Usual CHW Care |
Primary outcome
Intervention Acceptability
Time frame: 30 days
Proportion of patients indicating that they would be willing to use the intervention again
Intervention Feasibility
Time frame: 30 days
Proportion of patients that used the intervention during the study period
4 secondary outcomes
30-day Readmission Rate
Time frame: 30 days
30-day Missed Appointment Rate
Time frame: 30 days
30-day Emergency Department Visit Rate
Time frame: 30 days
Heart Failure Knowledge (Associated With a Subset of Participants Assessed for This Measure Prior to Being Randomized to the Intervention or Control Arm)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23616602Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
- Background: PubMed 23151591McHugh MD, Ma C. Hospital nursing and 30-day readmissions among Medicare patients with heart failure, acute myocardial infarction, and pneumonia. Med Care. 2013 Jan;51(1):52-9. doi: 10.1097/MLR.0b013e3182763284.
- Background: PubMed 29101131Abdel-All M, Putica B, Praveen D, Abimbola S, Joshi R. Effectiveness of community health worker training programmes for cardiovascular disease management in low-income and middle-income countries: a systematic review. BMJ Open. 2017 Nov 3;7(11):e015529. doi: 10.1136/bmjopen-2016-015529.
- Background: PubMed 29703724Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27.
- Derived from this study: PubMed 38959294Carter JAC, Swack N, Isselbacher E, Donelan K, Thorndike A. Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Pilot Randomized Controlled Trial. JMIR Cardio. 2024 Aug 8;8:e59948. doi: 10.2196/59948.
- Derived from this study: PubMed 38216543Carter J, Swack N, Isselbacher E, Donelan K, Thorndike A. Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 6;13:e55687. doi: 10.2196/55687.
- Individual participant dataSharing planned: Yes. The data can be available by request only after academic journal publication. Any formal requests should be sent by external research teams and will be reviewed by the corresponding author.
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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.
Jocelyn Carter, MD principal investigator
Massachusetts General 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 Digitally-enabled CHW Care and Usual CHW Care in people with Heart Failure，Congestive, run by Massachusetts General 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 6 inclusion and 4 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 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intervention Acceptability (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 NCT05130008, which also lists 6 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 20 Apr 2025.