CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 255 enrolled
Drug / intervention
spouse-assisted interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00321789
NCT00321789N/ACompleted

A Patient-Spouse Intervention for Self-Managing High Cholesterol

US Department of Veterans Affairs·interventional·Posted May 4, 2006·Updated Apr 24, 2015

In Brief

A clinical study evaluating spouse-assisted intervention for Hypercholesterolemia. Completed, enrolled 255 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2006
Enrollment StartSep 1, 2007
Primary CompletionJul 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.2 years ago

Interventions

spouse-assisted interventionbehavioral

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.