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
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.
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:
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 →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.
Patients:
Inclusion Criteria:
Exclusion Criteria:
Providers:
Inclusion Criteria: Care team members who participate in the study clinic.
The intervention arm will receive usual care, a free blood pressure cuff in addition to the ASPIRE Components.
Behavioral: ASPIRE Intervention
The control group will receive usual care and a free blood pressure cuff.
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.
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
Change in systolic blood pressure (SBP)
difference in the mean change in SBP (mmHg) between the intervention and control arms
Time frame: 3 months
Change in diastolic blood pressure (DBP)
difference in the mean change in DBP (mmHg) between the intervention and control arms
Time frame: 3 months
Blood pressure control
proportion of patients with controlled blood pressure (mmHg)
Time frame: 3 months
Medication intensification
proportion of patients who had a medication intensification.
Time frame: 3 months
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
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
Plan to share: No
No publications or documents are linked to this record.
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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Wake Forest University Health Sciences