N/A
N=255
A Patient-Spouse Intervention for Self-Managing High Cholesterol
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00321789 ↗Enrolled (actual)
255
Serious AEs
0.4%
Results posted
Sep 2014
Primary outcome: Primary: Low-density Lipoprotein Cholesterol — 123.6; 115.3 mg/dL — p=0.44
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- spouse-assisted intervention (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low-density Lipoprotein Cholesterol |
123.6; 115.3 | 0.44 |
| SECONDARY Caloric Intake |
1175.3; 1253.9 | 0.03 sig |
| SECONDARY Saturated Fat (Grams/Day) |
15.1; 17.4 | 0.02 sig |
| SECONDARY Total Fat (Grams/Day) |
46.5; 54.2 | 0.02 sig |
| SECONDARY Cholesterol Intake |
152.1; 175.5 | 0.11 |
| SECONDARY Fiber Intake |
13.2; 11.9 | 0.26 |
| SECONDARY Frequency of Moderate Intensity Physical Activity |
10; 10 | 0.06 |
| SECONDARY Duration of Moderate Intensity Physical Activity |
7.3; 7.8 | 0.37 |
| SECONDARY Total Fat (%) |
35.4; 38.2 | 0.04 sig |
| SECONDARY Saturated Fat (%) |
11.4; 12.3 | 0.09 |
| SECONDARY Number of Participants With Goal LDL-C |
57; 62 | 0.87 |
| SECONDARY Number of Participants Prescribed Cholesterol Medication |
56; 56 | — |
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.
Eligibility Criteria
Inclusion Criteria
- veteran
- elevated baseline low-density lipoprotein cholesterol level
- married
Exclusion Criteria
- no telephone number;
- spouse unwilling to participate;
- patient or spouse cognitively impaired, unable to communicate via telephone, living in nursing home or receiving home health care, or refuses to provide informed consent;
- hospitalized past 3 months;
- survival prognosis less than 1 year;
- active psychosis or dementia; no primary care physician at VA;
- no medical visit to VA in past year;
- enrolled in another study focusing on lifestyle changes
Data sourced from ClinicalTrials.gov (NCT00321789). 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.