NCT00321789

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

September 26, 2014

Completed
Last Updated

April 24, 2015

Status Verified

August 1, 2014

Enrollment Period

2.8 years

First QC Date

May 3, 2006

Results QC Date

September 2, 2014

Last Update Submit

April 6, 2015

Conditions

Hypercholesterolemia

Keywords

self caresocial support

Outcome Measures

Primary Outcomes (1)

  • Low-density Lipoprotein Cholesterol

    assessed with non-fasting blood test

    11-month follow-up

Secondary Outcomes (11)

  • Caloric Intake

    11-month follow-up

  • Saturated Fat (Grams/Day)

    11-month follow-up

  • Total Fat (Grams/Day)

    11-month follow-up

  • Cholesterol Intake

    11-month follow-up

  • Fiber Intake

    11-month follow-up

  • +6 more secondary outcomes

Study Arms (2)

Spouse-assisted intervention

EXPERIMENTAL

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

Behavioral: spouse-assisted intervention

Usual care

NO INTERVENTION

Couples assigned to this arm received educational materials at baseline and usual care thereafter, with no contact from the study interventionist.

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.

Spouse-assisted intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • veteran
  • elevated baseline low-density lipoprotein cholesterol level
  • married

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

  • Voils CI, Yancy WS Jr, Weinberger M, Bolton J, Coffman CJ, Jeffreys A, Oddone EZ, Bosworth HB. The trials and tribulations of enrolling couples in a randomized, controlled trial: a self-management program for hyperlipidemia as a model. Patient Educ Couns. 2011 Jul;84(1):33-40. doi: 10.1016/j.pec.2010.06.005. Epub 2010 Jul 5.

    PMID: 20599337RESULT

  • Voils CI, Yancy WS Jr, Kovac S, Coffman CJ, Weinberger M, Oddone EZ, Jeffreys A, Datta S, Bosworth HB. Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) - a randomized, controlled trial. Trials. 2009 Feb 6;10:10. doi: 10.1186/1745-6215-10-10.

    PMID: 19200384RESULT

  • Voils CI, Coffman CJ, Yancy WS Jr, Weinberger M, Jeffreys AS, Datta S, Kovac S, McKenzie J, Smith R, Bosworth HB. A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol. Prev Med. 2013 Jan;56(1):46-52. doi: 10.1016/j.ypmed.2012.11.001. Epub 2012 Nov 9.

    PMID: 23146744RESULT

  • Gallagher P, Yancy WS Jr, Jeffreys AS, Coffman CJ, Weinberger M, Bosworth HB, Voils CI. Patient self-efficacy and spouse perception of spousal support are associated with lower patient weight: baseline results from a spousal support behavioral intervention. Psychol Health Med. 2013;18(2):175-81. doi: 10.1080/13548506.2012.715176. Epub 2012 Sep 10.

    PMID: 22963235RESULT

  • King HA, Jeffreys AS, McVay MA, Coffman CJ, Voils CI. Spouse health behavior outcomes from a randomized controlled trial of a spouse-assisted lifestyle change intervention to improve patient low-density lipoprotein cholesterol. J Behav Med. 2014 Dec;37(6):1102-7. doi: 10.1007/s10865-014-9559-4. Epub 2014 Mar 2.

    PMID: 24584818RESULT

  • Sperber NR, Sandelowski M, Voils CI. Spousal support in a behavior change intervention for cholesterol management. Patient Educ Couns. 2013 Jul;92(1):121-6. doi: 10.1016/j.pec.2013.02.015. Epub 2013 Mar 27.

    PMID: 23541217RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Limitations and Caveats

The dietary measure underestimates dietary intake but should not invalidate differences between groups or across time. Sample size for dietary analyses was reduced due to missing data, but non-responders did not differ on measured characteristics.

Results Point of Contact

Title
Corrine I. Voils
Organization
Veterans Affairs Medical Center
corrine.voils@va.gov
919-286-0411

Study Officials

  • Corrine I. Voils, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2006

First Posted

May 4, 2006

Study Start

September 1, 2007

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

April 24, 2015

Results First Posted

September 26, 2014

Record last verified: 2014-08

Locations

US(1)