RECRUITING

Mobile Health Program for Rural Hypertension

Conditions

Hypertension,Essential Adherence, Medication Quality of Life hypertension adherence rurality

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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

Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).

Official Title

Multilevel Mobile Health Program to Improve Rural Hypertension

Quick Facts

Study Start:2023-09-04

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05546931

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. History of uncontrolled hypertension, identified from the electronic health record problem list and an average systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits, one of which is within 6 months of study entry 2. Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania; 3. English-speaking at level appropriate for informed consent and study participation; 4. No plans to relocate from the area within 12 months of enrollment.	1. Heart failure necessitating hospital admission ≤3 months prior to study inclusion; 2. Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion; 3. Planned major surgery, cardiovascular or non-cardiovascular; 4. Pregnancy or planned pregnancy within 12 months; 5. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer); 6. Inability to comprehend the study protocol, defined by failing 3 times to answer correctly a set of questions during consent; 7. Institutionalized status (e.g., nursing home, incarceration); 8. Inability to operate a smartphone or HBPM device due to sensory or neurocognitive deficit.

Inclusion Criteria

Exclusion Criteria

1. History of uncontrolled hypertension, identified from the electronic health record problem list and an average systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits, one of which is within 6 months of study entry
2. Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania;
3. English-speaking at level appropriate for informed consent and study participation;
4. No plans to relocate from the area within 12 months of enrollment.

1. Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
2. Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;
3. Planned major surgery, cardiovascular or non-cardiovascular;
4. Pregnancy or planned pregnancy within 12 months;
5. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
6. Inability to comprehend the study protocol, defined by failing 3 times to answer correctly a set of questions during consent;
7. Institutionalized status (e.g., nursing home, incarceration);
8. Inability to operate a smartphone or HBPM device due to sensory or neurocognitive deficit.

Contacts and Locations

Study Contact

Jared W Magnani, MD

CONTACT

4123830611

magnanij@pitt.edu

Study Locations (Sites)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

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 Date2023-09-04

Study Completion Date2027-06

Study Record Updates

Study Start Date2023-09-04

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

hypertension
adherence
rurality

Additional Relevant MeSH Terms

Hypertension,Essential
Adherence, Medication
Quality of Life