The Relevance of Living Supports on Antiplatelet Adherence and Trial Participation: The SPS3 Trial

Abstract

Background

While living with others has been associated with improved functional outcome after acute stroke, it is unclear if this affects adherence to stroke prevention measures.

Aims

We examined the relationship between living arrangements and adherence to antiplatelet therapy assignment and participation status in an international randomized trial for secondary stroke prevention.

Method

Antiplatelet therapy adherence, trial retention outcomes, and baseline characteristics for participants enrolled in the Secondary Prevention of Small Subcortical Strokes study were compared between those who lived alone vs. with others (n = 2374). Participant status at end-of-trial was categorized into (1) on assigned antiplatelet, (2) off assigned anti-platelet by participant request, or (3) participant withdrew consent/lost to follow-up. Multivariable multivariate logistic regression was used to identify patient features at entry predictive of participant status at trial end.

Results

Living arrangement, alone vs. with other(s), was not significantly associated with participant status. Participants enrolled in the United States/Canada (odds ratio 3·1, confidence intervals 2·0–5·0, vs. Latin America), taking more (7+) prescription medications (odds ratio 1·7, confidence intervals 1·1–2·7, vs. 0–2 medications), and scoring lower on the Stroke Specific Quality of Life scale (odds ratio 1·3, confidence intervals 1·1–1·5, per 10 points) were more likely to withdraw or become lost to follow-up in the study vs. completing the study on assigned antiplatelet therapy. Participants enrolled in the United States/Canada (odds ratio 5·0, confidence intervals 2·4–10·0, vs. Latin America) and taking fewer (0–2) medications (odds ratio 1·9, confidence intervals 1·2–3·1 vs. 3–6 medications) were more likely to request discontinuation of assigned antiplatelet medication vs. completing the study.

Conclusion

Living with others was not independently predictive of protocol adherence in this cohort. Number of medications and Stroke Specific Quality of Life scale score may be more indicative of likelihood of trial participation and acceptance of long-term antiplatelet regimen.

Keywords

adherence antiplatelet therapy clinical trial living support retention stroke

Get full access to this article

View all access options for this article.

References

Gliksman

Lazarus

Wilson

Leeder

. Social support, marital status and living arrangement correlates of cardiovascular disease risk factors in the elderly. Soc Sci Med 1995; 40: 811–4.

Lau

Kirby

. The relationship between living arrangement and preventive care use among community-dwelling elderly persons. Am J Public Health 2009; 99: 1315–21.

Bushnell

Olson

Zhao

. Secondary preventive medication persistence and adherence 1 year after stroke. Neurology 2011; 77: 1182–90.

Jørgensen

Nakayama

Raaschou

Olsen

. Acute stroke care and rehabilitation: An analysis of the direct cost and its clinical and social determinants. The copenhagen stroke study. Stroke 1997; 28: 1138–41.

Orensky

Holdford

. Predictors of noncompliance with warfarin therapy in an outpatient anticoagulation clinic. Pharmacotherapy 2005; 25: 1801–8.

Kotila

Waltimo

Niemi

Laaksonen

Lempinen

. The profile of recovery from stroke and factors influencing outcome. Stroke 1984; 15: 1039–44.

Reid

Dai

Christian

. Developing predictive models of excellent and devastating outcome after stroke. Age Ageing 2012; 41: 560–4.

Ayis

Coker

Rudd

Dennis

Wolfe

CDA

. Predicting independent survival after stroke: A european study for the development and validation of standardised stroke scales and prediction models of outcome. J Neurol Neurosurg Psychiatry 2013; 84: 288–96.

Antiplatelet Trialists' Collaboration. Collaborative overview of randomised trials of antiplatelet therapy – I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ 1994; 308: 81–106.

10.

De Schryver

ELLM

Van Gijn

Kappelle

Koudstaal

Algra

. Non-adherence to aspirin or oral anticoagulants in secondary prevention after ischaemic stroke. J Neurol 2005; 252: 1316–21.

11.

DiMatteo

. Social support and patient adherence to medical treatment: A meta-analysis. Health Psychol 2004; 23: 207–18.

12.

Counsell

Dennis

McDowall

. Predicting functional outcome in acute stroke: Comparison of a simple six variable model with other predictive systems and informal clinical prediction. J Neurol Neurosurg Psychiatry 2004; 75: 401–5.

13.

Benavente

White

Pearce

. The secondary prevention of small subcortical strokes (SPS3) study. Int J Stroke 2011; 6: 164–75.

14.

Benavente

Hart

McClure

, The SPS3 Investigators. Effects of clopidogrel added to aspirin in patients with recent lacunar stroke. N Engl J Med 2012; 367: 817–25.

15.

Benavente

Coffey

Conwit

. SPS3 Study Group. Blood-pressure targets in patients with recent lacunar stroke: The SPS3 randomised trial. Lancet 2013; 382: 506.

16.

Quinn

Langhorne

Stott

. Barthel index for stroke trials: Development, properties, and application. Stroke 2011; 42: 1146–51.

17.

Jacova

Pearce

Costello

. Cognitive impairment in lacunar strokes: The SPS3 trial. Ann Neurol 2012; 72: 351–62.

18.

Williams

Weinberger

Harris

Clark

Biller

. Development of a stroke-specific quality of life scale. Stroke 1999; 30: 1362–9.

19.

Farhat

Velanovich

Falvo

. Are the frail destined to fail? frailty index as predictor of surgical morbidity and mortality in the elderly. J Trauma Acute Care Surg 2012; 72: 1526–30.

20.

Rudd

Byyny

Zachary

. Pill count measures of compliance in a drug trial: Variability and suitability. Am J Hypertens 1988; 1: 309–12.

21.

Farmer

. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther 1999; 21: 1074–90.

22.

Van Onzenoort

Verberk

Kroon

. Electronic monitoring of adherence, treatment of hypertension, and blood pressure control. Am J Hypertens 2012; 25: 54–9.

23.

De Haan

Limburg

Van der Meulen

Jacobs

Aaronson

. Quality of life after stroke. Impact of stroke type and lesion location. Stroke 1995; 26: 402–8.

24.

Norrving

. Long-term prognosis after lacunar infarction. Lancet Neurol 2003; 2: 238–45.

25.

Vermeire

Hearnshaw

Van Royen

Denekens

. Patient adherence to treatment: Three decades of research. A comprehensive review. J Clin Pharm Ther 2001; 26: 331–42.

26.

Eraker

Kirscht

Becker

. Understanding and improving patient compliance. Ann Intern Med 1984; 100: 258–68.