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CompletedNCT06175793Updated Apr 11, 2025

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

An interventional study of ASPIRE Intervention in Hypertension, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-11.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 50 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Patients:

Inclusion criteria

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    ASPIRE Intervention Arm

    The intervention arm will receive usual care, a free blood pressure cuff in addition to the ASPIRE Components.

    Behavioral: ASPIRE Intervention

  • No intervention
    Control Arm

    The control group will receive usual care and a free blood pressure cuff.

Interventions

  • BehavioralASPIRE Intervention

    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.

06

What researchers measure

Primary outcomes

  1. SMBP Feasibility

    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.

    Time frame: 1 month

Secondary outcomes

  1. Change in systolic blood pressure (SBP)

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

    Time frame: 3 months

  2. Change in diastolic blood pressure (DBP)

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

    Time frame: 3 months

  3. Blood pressure control

    proportion of patients with controlled blood pressure (mmHg)

    Time frame: 3 months

  4. Medication intensification

    proportion of patients who had a medication intensification.

    Time frame: 3 months

Other outcomes

  1. Patient and Care Team Acceptability

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

    Time frame: 1 month

  2. Patients and Care Team Satisfaction

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

    Time frame: 1 month

07

Study locations

1 site
  • ADMG Oak Lawn IM Clinci
    Oak Lawn, Illinois 60453, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06175793
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Dec 19, 2023
Start date
Jan 15, 2024
Primary completion
May 31, 2024
Completion
May 31, 2024
Last update
Apr 11, 2025

Study contacts

Rasha Khatib, PhD
principal investigator · Advocate Aurora Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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