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Behavioral support intervention for uncontrolled hypertension: a complier average causal effect (CACE) analysis

Yuanyuan Liang1, Benjamin R Ehler, Christopher S Hollenbeak

  • 1*Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio (UTHSCSA) †Center for Research to Advance Community Health ‡Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio §School of Public Health, University of Texas Health Science Center at Houston, Houston ∥Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio, San Antonio, TX ¶Departments of Surgery and Public Health Sciences, Penn State College of Medicine, Hershey, PA #University Health System **Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX.

Medical Care
|December 28, 2012
PubMed

Insights

The Peer Coach and Office Staff Support Trial found that adherence to the intervention significantly reduced coronary heart disease risk and systolic blood pressure in compliers. Non-compliers may require more intensive interventions for similar benefits.

Area of Science:

  • Cardiovascular disease research
  • Public health interventions
  • Clinical trial methodology

Background:

  • Randomized controlled trials (RCTs) often face challenges with participant noncompliance and missing data.
  • Complier Average Causal Effect (CACE) analysis is a statistical method to address these issues in RCTs.
  • Understanding intervention effects in compliers is crucial for evaluating treatment efficacy.

Purpose of the Study:

  • To perform a CACE analysis on the Peer Coach and Office Staff Support Trial.
  • To determine the intervention's effect on participants who adhered to the treatment (compliers).
  • To compare CACE findings with traditional intention-to-treat (ITT) analysis results.

Main Methods:

  • A randomized controlled trial involving 280 African American patients (aged 40-75) with uncontrolled hypertension.
  • Primary outcome: Change in 4-year coronary heart disease (CHD) risk.
  • Secondary outcome: Change in systolic blood pressure (SBP) over a 6-month intervention period.

Main Results:

  • Compliers (68% of intervention group) had better data completion and lower baseline CHD risk and SBP than noncompliers.
  • ITT analysis showed no significant effect on CHD risk (P=0.08) but a significant effect on SBP (P=0.003).
  • CACE analysis revealed a 1% greater reduction in 4-year CHD risk (P<0.05) and at least 8.1 mm Hg greater SBP reduction (P<0.05) for compliers receiving the intervention compared to controls.

Conclusions:

  • The intervention significantly reduced CHD risk and SBP among compliers.
  • Effective intervention delivery is key to achieving positive health outcomes.
  • Non-compliers may necessitate more intensive or tailored support strategies to benefit from interventions.
Abstract

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