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Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure

Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05130008
Enrollment
56
Registered
2021-11-22
Start date
2022-09-23
Completion date
2024-08-31
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure,Congestive

Keywords

community health worker care, digital platform, remote monitoring, readmissions, clinical trial, heart failure

Brief 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 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.

Interventions

OTHERDigitally-enabled CHW Care

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.

BEHAVIORALUsual CHW Care

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor team will be blinded to the intervention assignments of participants. Due to the nature of the intervention, the participants, the investigator, and the care providers are unable to be blinded to the participant assignments.

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Cognitive deficits that prevent digital or human engagement * Lack of health insurance * Invoked health proxy or guardianship status * History of smart phone use

Design outcomes

Primary

MeasureTime frameDescription
Intervention Acceptability30 daysProportion of patients indicating that they would be willing to use the intervention again
Intervention Feasibility30 daysProportion of patients that used the intervention during the study period

Secondary

MeasureTime frameDescription
Heart Failure Knowledge (Associated With a Subset of Participants Assessed for This Measure Prior to Being Randomized to the Intervention or Control Arm)BaselineProportion of patients perceiving their heart failure knowledge as very good or good (per an internally validated knowledge questionnaire; very good, good, fair, poor)
30-day Readmission Rate30 daysProportion of patients readmitted to the hospital within 30-days after hospital discharge
30-day Missed Appointment Rate30 daysProportion of patients missing PCP or specialty appointments within 30-days after hospital discharge
30-day Emergency Department Visit Rate30 daysProportion of patients returning to the Emergency Department within 30-days of hospital discharge

Other

MeasureTime frameDescription
Medication Compliance30 daysProportion of patients demonstrating improved medication compliance on the MMAS after the intervention
Quality of Life (Patient Perceptions and Attitudes, Functionality and Mobility)30 daysProportion of patients demonstrating improved perceived quality of life on the KCCQ after the intervention
Patient Satisfaction30 daysProportion of patients indicating after intervention that they were satisfied on a scale ranging from satisfied to neutral to not satisfied

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
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. Digitally-enabled CHW Care: 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.
25
Usual CHW Care
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. Usual CHW Care: 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.
31
Total56

Baseline characteristics

CharacteristicInterventionUsual CHW CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
8 Participants10 Participants18 Participants
Age, Categorical
Between 18 and 65 years
17 Participants21 Participants38 Participants
Age, Continuous61.6 years
STANDARD_DEVIATION 16.3
69.4 years
STANDARD_DEVIATION 10.3
65.1 years
STANDARD_DEVIATION 12.9
Race/Ethnicity, Customized
Asian, non-Hispanic
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Black, non-Hispanic
3 Participants6 Participants9 Participants
Race/Ethnicity, Customized
Hispanic/ Latin
2 Participants2 Participants4 Participants
Race/Ethnicity, Customized
More than one race
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White, non-Hispanic
17 Participants22 Participants39 Participants
Region of Enrollment
United States
25 participants31 participants56 participants
Sex: Female, Male
Female
11 Participants17 Participants28 Participants
Sex: Female, Male
Male
14 Participants14 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 251 / 31
other
Total, other adverse events
0 / 250 / 31
serious
Total, serious adverse events
0 / 251 / 31

Outcome results

Primary

Intervention Acceptability

Proportion of patients indicating that they would be willing to use the intervention again

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionIntervention Acceptability19 Participants
Usual CHW CareIntervention Acceptability25 Participants
Primary

Intervention Feasibility

Proportion of patients that used the intervention during the study period

Time frame: 30 days

Population: Given the specificity of the heart failure intervention, feasibility or use of the intervention may reflect 100% of participants being engaged with the intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionIntervention Feasibility19 Participants
Usual CHW CareIntervention Feasibility28 Participants
Secondary

30-day Emergency Department Visit Rate

Proportion of patients returning to the Emergency Department within 30-days of hospital discharge

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention30-day Emergency Department Visit Rate8 Participants
Usual CHW Care30-day Emergency Department Visit Rate7 Participants
Secondary

30-day Missed Appointment Rate

Proportion of patients missing PCP or specialty appointments within 30-days after hospital discharge

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention30-day Missed Appointment Rate0 Participants
Usual CHW Care30-day Missed Appointment Rate3 Participants
Secondary

30-day Readmission Rate

Proportion of patients readmitted to the hospital within 30-days after hospital discharge

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention30-day Readmission Rate3 Participants
Usual CHW Care30-day Readmission Rate8 Participants
Secondary

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)

Time frame: Baseline

Population: Aim 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionHeart Failure Knowledge (Associated With a Subset of Participants Assessed for This Measure Prior to Being Randomized to the Intervention or Control Arm)25 Participants
Other Pre-specified

Medication Compliance

Proportion of patients demonstrating improved medication compliance on the MMAS after the intervention

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionMedication Compliance8 Participants
Usual CHW CareMedication Compliance5 Participants
Other Pre-specified

Patient Satisfaction

Proportion of patients indicating after intervention that they were satisfied on a scale ranging from satisfied to neutral to not satisfied

Time frame: 30 days

Population: Participants indicating after intervention that they were satisfied on a scale ranging from satisfied to neutral to not satisfied

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionPatient Satisfaction19 Participants
Usual CHW CarePatient Satisfaction26 Participants
Other Pre-specified

Quality of Life (Patient Perceptions and Attitudes, Functionality and Mobility)

Proportion of patients demonstrating improved perceived quality of life on the KCCQ after the intervention

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionQuality of Life (Patient Perceptions and Attitudes, Functionality and Mobility)16 Participants
Usual CHW CareQuality of Life (Patient Perceptions and Attitudes, Functionality and Mobility)15 Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026