Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTulane University
About this trial
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness, implementation, and sustainability of a community health worker (CHW)-led multifaceted intervention compared to enhanced usual care for hypertension control in Black communities. In the BLESSED trial, the investigators plan to recruit 1,176 adults with hypertension (approximately 28 per church) from 42 predominantly Black churches in the Greater New Orleans area. The multifaceted intervention will last for 18 months, followed by a post-intervention follow-up visit at 24 months. The BLESSED trial aims to generate evidence regarding the effectiveness, implementation, and sustainability of this CHW-led church-based multifaceted intervention in eliminating hypertension disparities in the United States (US) general population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women aged ≥18 years
Community members associated with the participating churches (church members and their families and friends)
Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg
Willing and able to participate in the intervention.
Disqualifiers
Prior hospitalization in the last 3 months for chronic heart failure or heart attack
Current diagnosis of cancer requiring chemotherapy or radiation therapy
Stage-5 chronic kidney disease requiring chronic dialysis or transplant
Pregnant or planning to become pregnant in the next 18 months
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline
BehavioralThe recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension
Treatment groups
1,176 Participants
are divided into 2 treatment groupsGroup A: Community health worker-led implementation strategyExperimental treatment 1 intervention
Group B: Group-based Education StrategyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in mean change of systolic blood pressure
Difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups
Time frame
Measured from baseline to 18 months2
Implementation fidelity summary score
The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home blood pressure (BP) monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive medications taken in patients with hypertension. The score ranged from zero to six with a higher score indicates greater fidelity.
Time frame
Measured at 6, 12, and 18 monthsSecondary outcomes
1
Difference in the proportion of patients with controlled BP between intervention and control groups
Difference in the proportion of patients with controlled BP (\<130/80 mm Hg) between intervention and control groups at 18 months
Time frame
Measured from baseline to 18 months2
Difference in mean change of diastolic BP
Difference in mean change of diastolic BP (DBP) from baseline to 18 months between intervention and control groups
Time frame
Measured from baseline to 18 months3
Side effects of medications and adverse events
Change in side effects of medications and adverse events from baseline to 18 months
Time frame
Measured from baseline to 18 months4
Cost-effectiveness
Cost-effectiveness assessed as incremental direct costs per additional percentage of hypertension control
Time frame
Measured from baseline to 18 monthsOther outcomes
1
Change in quality of life
The difference in QoL between the two arms over 18 months. QoL will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame
Measured from baseline to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tulane University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov