Skip to main content
OpenTrials
Completed

NCT Number: NCT06175793

ASPIRE: Adapting Self-Blood Pressure Monitoring to Reduce Health Disparities

The goal of this study is to implement a pilot focusing on developing training manuals and materials for patients and the clinical team to ensure our intervention is delivered consistently and systematically for each patient.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ADMG Oak Lawn IM Clinci

Oak Lawn, Illinois, 60453, United States

About this study

Barriers to blood pressure control are multi-faceted and a silver-bullet solution/intervention does not exist. Therefore, the literature highlights the importance of creating multi-component interventions when addressing blood pressure control. The ASPIRE intervention consists of 5 components identified based on the study team's prior work and review of the literature.

Patients randomized to the intervention arm will receive all 5 components of the ASPIRE intervention. Patients randomized to the control arm will receive only the first component of the ASPIRE intervention and will continue to receive usual care. The ASPIRE intervention consists of 5 components aimed at supporting both patients and clinic care teams in successfully adopting self-measured blood pressure (SMBP) into their clinic workflow.

The 5 ASPIRE components are:

  • Access to cuff (Patient). Patients in the intervention arm and control arm will be measured for and will receive a blood pressure monitoring device to take home and keep beyond the study timeline.
  • Training (Patient). Only patients in the intervention arm will receive training and support on how to accurately measure their blood pressure. They will receive a folder containing an infographic that demonstrates how to accurately measure blood pressure at home. They will also receive a lifestyle infographic describing what they can do to improve their blood pressure.
  • Clear instructions (Patient). Patients in the intervention arm will also receive clear instructions on how to keep a record of their home blood pressure measures and share with their care team. They will be provided with a 7-day blood pressure long that details the number of blood pressure values they need to take in the mornings and evenings for seven days. Additionally, a clinic care team member serving as the ASPIRE coach will follow up with the intervention patients via a scheduled virtual call one week after they receive their materials (blood pressure monitoring device, infographics, and 7-day blood pressure log) to provide further support and instructions on self-measured blood pressure and to emphasize the importance of returning the blood pressure values to their care team.
  • SMBP EHR Documentation (ASPIRE Coach). To facilitate documentation of home blood pressure values in the electronic health record (EHR), the ASPIRE coach will average the blood pressure values patients return and document that average in the EHR. These home blood pressure averages will be shared with the patient's doctor who can use these values to modify treatment as appropriate.
  • Address Social Determinants of Health (Patient). Patients will be screened for social needs via a social determinants of health (SDOH) questionnaire that they will be asked to return to the care team. During the one week follow up virtual call the ASPIRE coach will address any identified social needs by following up with referrals as needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients:

Inclusion criteria

  • Adults >=18 years old
  • At least a 1-year history of hypertension
  • Must have at least one clinic visit during the study recruitment period (qualifying visit)
  • An elevated blood pressure value during their qualifying visit (defined as SBP above 140mm/Hg or DBP above 90mm/Hg)
  • Must be on at least one blood pressure lowering medication
  • Able to provide consent

Exclusion criteria

  • Patients residing in a nursing home or receiving home health care
  • Patients that don't speak English

Providers:

Inclusion criteria

Care team members who participate in the study clinic.

Treatment and study plan

ASPIRE Intervention

Behavioral

In addition to usual care and a free blood pressure cuff, participants in the intervention arm will receive the ASPIRE components: (1) ASPIRE Tool Kit, (2) ASPIRE Coach, (3) SMBP EHR Documentation, and (4) screening and addressing SDOHs.

Primary outcomes

  1. SMBP Feasibility

    Time frame: 1 month

    Feasibility of study methods will be evaluated using EHR data and returned SMBP logs and will include recruitment rates following patient's hypertension visits and loss to follow up rate over the 1 month follow up period.

Secondary outcomes

  1. Change in systolic blood pressure (SBP)

    Time frame: 3 months

    difference in the mean change in SBP (mmHg) between the intervention and control arms

  2. Change in diastolic blood pressure (DBP)

    Time frame: 3 months

    difference in the mean change in DBP (mmHg) between the intervention and control arms

  3. Blood pressure control

    Time frame: 3 months

    proportion of patients with controlled blood pressure (mmHg)

  4. Medication intensification

    Time frame: 3 months

    proportion of patients who had a medication intensification.

Other outcomes

  1. Patient and Care Team Acceptability

    Time frame: 1 month

    Patient and care team acceptability of the research methods and ASPIRE components will be evaluated based on in-depth interviews.

  2. Patients and Care Team Satisfaction

    Time frame: 1 month

    Patient and care team satisfaction with the research methods and ASPIRE components will be evaluated based on in-depth interviews.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2023
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.