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A Patient-Spouse Intervention for Self-Managing High Cholesterol

NCT00321789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2015-04-24

Study results available
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Summary

We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. A randomized controlled trial compared a one-year, telephone-based patient-spouse intervention to usual care. The primary outcome was LDL-C measured three times (baseline, 6 months, 11 months); secondary outcomes were adherence to medication, diet, and exercise, also assessed at baseline, 6 months, and 11 months.

Conditions

Interventions

BEHAVIORAL

spouse-assisted intervention

Couples assigned to this arm received nine monthly phone calls from a nurse. The patient created monthly goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. The spouse created plans to support patient goal achievement.

Sponsors & Collaborators

Principal Investigators

  • Corrine I. Voils, PhD · Durham VA Medical Center, Durham, NC

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-07-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00321789 on ClinicalTrials.gov