N/A
Completed N=1,820
Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project)
Uncontrolled Hypertension
Source: ClinicalTrials.gov NCT02674464 ↗
Enrolled (actual)
1,820
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Number of Participants With Controlled Blood Pressure — 462; 442 Participants — p=0.68
Summary
The RICH LIFE Project is a two-armed, cluster-randomized trial, comparing the effectiveness of an enhanced standard of care arm, "Standard of Care Plus" (SCP), to a multi-level intervention, "Collaborative Care/Stepped Care" (CC/SC), in improving blood pressure control, patient activation and reducing disparities in blood pressure control among 1,890 adult patients with uncontrolled hypertension and cardiovascular disease risk factors at thirty primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized blood pressure measurement training, and audit and feedback of blood pressure control rates at the practice provider level. Fifteen practices in the CC/SC arm receive all the SCP interventions plus the implementation of the collaborative care model with additional stepped-care components of community health worker referrals and subspecialist curbside consults and an on-going virtual workshop for organizational leaders in quality improvement and disparities reduction. The primary clinical outcomes are the percent of patients with blood pressure <140/90 mm Hg and change from baseline in mean systolic blood pressure at 12 months. The primary patient reported outcome is change from baseline in self-reported patient activation at 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Controlled Blood Pressure |
462; 442 | 0.68 |
| PRIMARY Patient Activation Measure (PAM-13) |
65.4; 66.1; 66.7; 67.9 | 0.60 |
| SECONDARY Mean Systolic Blood Pressure |
151.8; 152.5; 137.1; 138.7 | 0.38 |
| SECONDARY Mean Diastolic Blood Pressure |
84.7; 86.7; 78.9; 79.8 | 0.05 |
| SECONDARY Change in Global Framingham Risk Score |
— | — |
| SECONDARY Change in Mean Total Cholesterol (mg/dL) |
— | — |
| SECONDARY Change in Mean LDL-C (mg/dL) |
— | — |
| SECONDARY Change in Mean HDL (mg/dL) |
— | — |
| SECONDARY % With Controlled Total Cholesterol |
— | — |
| SECONDARY Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c) |
— | — |
| SECONDARY % With Hemoglobin A1c< 7.0 |
— | — |
| SECONDARY Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus) |
— | — |
| SECONDARY % With BP <140/90 mmHg |
— | — |
| SECONDARY % With BP <130/80 mmHg |
— | — |
| SECONDARY % With BP <120/80 mmHg |
— | — |
| SECONDARY Change in Medication Adherence 4-Item Scale |
— | — |
| SECONDARY Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score |
— | — |
| SECONDARY Change in Patient Ratings of Trust |
— | — |
| SECONDARY Change in Hypertension Knowledge and Attitudes |
— | — |
| SECONDARY Change in Health Related Quality of Life (PROMIS Global Scale) |
— | — |
| SECONDARY Change in Patient Attainment of Self-Defined Goals |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients (≥21 years of age) obtaining primary care from a provider at a participating practice
- A diagnosis of hypertension or SBP≥140mmHg or DBP≥90mmHg twice in the past year or on antihypertensive medications plus at least one of the following CVD risk factors:
- Diabetes mellitus (fasting blood sugar> 125mg/dl or hemoglobin A1c>6.5 or on a hypoglycemic medication);
- Dyslipidemia (LDL >130 mg/dl, HDL 200 or on a lipid lowering agent);
- Coronary heart disease
- Current tobacco smokers
- Depression by International Classification of Disease, 9th edition (ICD-9), codes or Patient Health Questionnaire (PHQ) score >9
Exclusion Criteria
- Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months
- Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician.
- Alcohol or substance use disorder if not sober/abstinent for ≥30 days
- Planning to leave clinic within 6 months or move out of geographic area within 18 months
- Individuals with cognitive impairment or other condition which makes them unable to participate in the intervention
- Participating in another lifestyle modification, weight reduction, or treatment trial
Data sourced from ClinicalTrials.gov (NCT02674464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.