Study 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.
Eligible Conditions
- Congestive Heart Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 3 Secondary · Reporting Duration: 12 months
12 months
30-day Emergency Department visit rate
30-day missed appointment rate
30-day readmission rate
Care Team Connection
Heart Failure Knowledge
Intervention Acceptability
Intervention Feasibility
Pharmaceutical Preparations
Patient Satisfaction
Quality of Life (patient perceptions and attitudes, functionality and mobility)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Usual CHW Care
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention · No Placebo Group · N/A
Intervention
Other
Experimental Group · 1 Intervention: Digitally-enabled CHW Care · Intervention Types: OtherUsual CHW Care
Behavioral
ActiveComparator Group · 1 Intervention: Usual CHW Care · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,588 Previous Clinical Trials
46,945,652 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,699 Previous Clinical Trials
30,843,082 Total Patients Enrolled
Jocelyn Carter, MDPrincipal InvestigatorMassachusetts General Hospital
Eligibility Criteria
Age 18 - 99 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a heart failure diagnosis.
References
- Heidenreich, Paul A., Nancy M. Albert, Larry A. Allen, David A. Bluemke, Javed Butler, Gregg C. Fonarow, John S. Ikonomidis, et al.. 2013. “Forecasting the Impact of Heart Failure in the United States”. Circulation: Heart Failure. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/hhf.0b013e318291329a.
- McHugh 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.
- Abdel-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. Review.
- Spencer, Michael S., Edith C. Kieffer, Brandy Sinco, Gretchen Piatt, Gloria Palmisano, Jaclynn Hawkins, Alana Lebron, et al.. 2018. “Outcomes at 18 Months from a Community Health Worker and Peer Leader Diabetes Self-management Program for Latino Adults”. Diabetes Care. American Diabetes Association. doi:10.2337/dc17-0978.
- 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.
- Abdel-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.
- Jocelyn Carter 2022. "Implementing a Digitally-enabled Community Health Worker Intervention for Patients With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130008.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments