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IIR 05-273 – HSR&D Study

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IIR 05-273
A Patient-Spouse Intervention for Self-Managing High Cholesterol
Corrine I. Voils PhD
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: September 2006 - August 2010

BACKGROUND/RATIONALE:
Coronary heart disease is a leading cause of death and nonfatal heart attacks. Self-management of common risk factors such as elevated low-density lipoprotein cholesterol (LDL-C) is important for reducing risk for future coronary events. Patient self-management interventions involving significant lifestyle changes have shown limited effectiveness. The effectiveness could be enhanced by targeting spouses, who function as informal caregivers.


OBJECTIVE(S):
We conducted a randomized, controlled trial to determine whether a spouse-supported, self-management intervention would improve LDL-C and related health behaviors in patients with elevated LDL-C.

METHODS:
255 veterans who were married and had LDL-C > 76 mg/dL were randomized with their spouses to the usual care or intervention arm. The intervention involved monthly phone calls from a nurse involving goal setting (for patients) or providing support for goal achievement (spouses). The primary outcome was LDL-C at 11 months. Secondary outcomes were dietary intake and frequency and duration of moderate intensity exercise. Linear mixed modeling was used to compare outcomes between arms adjusting for baseline randomization stratification variables (White vs. Black race and low vs. medium/high coronary heart disease risk level). Because the distributions of the dietary variables were skewed, a square root transformation was conducted to normalize model residuals.

FINDINGS/RESULTS:
Patients were 95% male and 64% White. Mean (SD) baseline LDL-C was 126.3 (26.3) mg/dL. Changes in LDL-C did not differ between intervention and control arms (p=0.44, estimate 2.3 mg/dL, 95% CI [-3.6, 8.2 mg/dL]). Dietary polysaturated fat intake decreased significantly more in the intervention than control arm (p=0.02, estimate -0.2 log units, 95% CI [-0.3, 0.0]), as did saturated fat intake (p=0.03, estimate = -0.2 log units, 95% CI [-0.3, 0.0]). Dietary cholesterol trended toward a greater decrease in the intervention than control arm (p=0.11, estimate =-0.1 log units, 95% CI [-0.3, 0.0]). Changes in fiber intake did not differ between groups (p=0.26, estimate = 0.1 log units, 95% CI [-0.1, 0.2]). Frequency of moderate intensity exercise per week trended toward a greater increase in the intervention arm than the control arm (p=0.12, estimate = 1.4 times per week, 95% CI [-0.4, 3.3]). Changes in duration of moderate intensity exercise did not differ between intervention and control arms (p=0.41, estimate = 0.7 hours per week, 95% CI [-0.9, 2.2]). The cost of the intervention was $148 per couple.

IMPACT:
A low-cost, nurse-delivered, telephone-based, spousal support intervention focusing on lifestyle changes was insufficient for improving LDL-C but resulted in important dietary changes and modest improved physical activity. The intervention tested in this trial directly addresses two important VA priorities: caregiving and access. The intervention aimed to improve the quality of informal caregiving around lifestyle changes for a common chronic disease and required little time burden from caregivers. Because the intervention is delivered by telephone, it could have wide reach, not requiring travel burden by veterans and their informal caregivers.

PUBLICATIONS:

Journal Articles

  1. McVay MA, King HA, Jeffreys AS, Coffman CJ, Voils CI. Mechanisms of patient health behavior change in a randomized controlled trial of a spouse-assisted intervention. Psychology, health & medicine. 2015 Mar 16; 20(7):753-66.
  2. 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. Journal of behavioral medicine. 2014 Dec 1; 37(6):1102-7.
  3. Gallagher P, Yancy WS, 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. Psychology, health & medicine. 2013 Aug 5; 18(2):175-81.
  4. Sperber NR, Sandelowski M, Voils CI. Spousal support in a behavior change intervention for cholesterol management. Patient education and counseling. 2013 Jul 1; 92(1):121-6.
  5. Voils CI, Coffman CJ, Yancy WS, 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. Preventive medicine. 2013 Jan 1; 56(1):46-52.
  6. Voils CI, Yancy WS, 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 education and counseling. 2011 Jul 1; 84(1):33-40.
  7. Voils CI, Yancy WS, 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.
Conference Presentations

  1. King HA, Coffman CJ, McVay M, Jeffreys AL, Voils CI. Similarity in patient and spouse outcomes from a spouse-assisted lifestyle intervention. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2015 Apr 25; San Antonio, TX.
  2. King HA, Jeffreys AL, McVay M, Coffman CJ, Voils CI. Spouse Outcomes from a Spouse-Assisted Lifestyle Intervention to Lower Patient Cholesterol. Poster session presented at: VA Durham VAMC Annual Research Week; 2013 May 15; Durham, NC.
  3. King HA, Coffman CJ, McVay M, Voils CI. Spouse outcomes from a spouse-assisted intervention to lower patient cholesterol. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2013 Mar 22; San Francisco, CA.
  4. Gallagher MP, Yancy WS, Weinberger M, Coffman CJ, Jeffreys AL, Bosworth HB. The relationship between patient and spouse psychosocial factors and patient weight: Baseline results from the Couples Partnering for Lipid Enhancing Strategies (CouPLES) trial. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2011 Apr 30; Washington, DC.
  5. Voils CI, Yancy WS, Coffman CJ, Weinberger M, Jeffreys AL, McKenzie JB, Bosworth HB. Primary outcomes from the Couples Partnering for Lipid Enhancing Strategies (CouPLES) trial. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2011 Apr 4; Washington, DC.
  6. Voils CI, Yancy WS, Coffman CJ, Jeffreys AL, McKenzie JB, Bosworth HB. Outcomes from the Couples Partnering for Lipid Enhancing Strategies (CouPLES) trial. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2011 Apr 1; Washington, DC.
  7. Voils CI, Yancy WS, Weinberger M, Coffman CJ, McKenzie JB, Jeffreys AL, Oddone EZ, Bosworth HB. The relationship between spousal support for exercise and diet behaviors: Baseline analyses from the Couples Partnering for Lipid-Enhancing Strategies (CouPLES) trial. Poster session presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2010 Apr 8; Seattle, WA.
  8. Voils CI. Couples-based health intervention studies: Overcoming the challenges. Paper presented at: Society of Behavioral Medicine Annual Meeting and Scientific Sessions; 2009 Apr 1; Montréal, Canada.


DRA: Aging, Older Veterans' Health and Care, Health Systems
DRE: Treatment - Observational, Prevention
Keywords: Adherence, Cardiovasc’r disease, Self-care
MeSH Terms: none