RECRUITING

A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

Conditions

Hypertension High Blood Pressure Diabetes Chronic Kidney Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.

Official Title

A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

Quick Facts

Study Start:2023-10-16

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05321368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 years of age as of date of data extraction, 2. Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic, 3. Diagnosis of Hypertension (HTN) defined by International Classification of Diseases, Tenth code (ICD-10 code) and elevated systolic blood pressure (SBP) measure (≥140 mm Hg) on their most recent clinic visit. 4. Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN 5. Receives primary medical care at one of the participating health systems 6. Have a Maryland and D.C. home address	1. Age \<18 years 2. Diagnosis of end-stage renal disease (ESRD) treated with dialysis 3. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer) 4. Cognitive impairment or other condition preventing participation in the intervention 5. Planning to leave the practice or move out of the geographic area in 24 months 6. No longer consider the practice site their location for primary care 7. Unwillingness to provide informed consent

Inclusion Criteria

Exclusion Criteria

1. 18 years of age as of date of data extraction,
2. Self-identify as non-Hispanic white, non-Hispanic Black/African American and/or Hispanic,
3. Diagnosis of Hypertension (HTN) defined by International Classification of Diseases, Tenth code (ICD-10 code) and elevated systolic blood pressure (SBP) measure (≥140 mm Hg) on their most recent clinic visit.
4. Diagnosis of diabetes or chronic kidney disease (both defined by ICD-10 code), in addition to HTN
5. Receives primary medical care at one of the participating health systems
6. Have a Maryland and D.C. home address

1. Age \<18 years
2. Diagnosis of end-stage renal disease (ESRD) treated with dialysis
3. Serious medical condition which either limits life expectancy or requires active management (e.g., cancer)
4. Cognitive impairment or other condition preventing participation in the intervention
5. Planning to leave the practice or move out of the geographic area in 24 months
6. No longer consider the practice site their location for primary care
7. Unwillingness to provide informed consent

Contacts and Locations

Study Contact

Yvonne Commodore-Mensah, PhD, MSH

CONTACT

443-614-1519

ycommod1@jhu.edu

Principal Investigator

Yvonne Commodore-Mensah, PhD, MSH, RN

PRINCIPAL_INVESTIGATOR

JHU School Of Nursing

Study Locations (Sites)

Choptank Community Health Systems

Denton, Maryland, 21629

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Yvonne Commodore-Mensah, PhD, MSH, RN, PRINCIPAL_INVESTIGATOR, JHU School Of Nursing

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2023-10-16

Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

Hypertension
High Blood Pressure
Diabetes
Chronic Kidney Diseases