clinicaltrials.gov Identifier: NCT00006206.

BackgroundPatient recruitment is one of the most difficult aspects of clinical trials, especially for research involving elderly subjects. In this paper, we describe our experience with patient recruitment for the behavioral intervention randomized trial, "The relaxation response intervention for chronic heart failure (RRCHF)." Particularly, we identify factors that, according to patient reports, motivated study participation.MethodsThe RRCHF was a three-armed, randomized controlled trial designed to evaluate the efficacy and cost of a 15-week relaxation response intervention on veterans with chronic heart failure. Patients from the Veterans Affairs (VA) Boston Healthcare System in the United States were recruited in the clinic and by telephone. Patients' reasons for rejecting the study participation were recorded during the screening. A qualitative sub-study in the trial consisted of telephone interviews of participating patients about their experiences in the study. The qualitative study included the first 57 patients who completed the intervention and/or the first follow-up outcome measures. Factors that distinguished patients who consented from those who refused study participation were identified using a t-test or a chi-square test. The reason for study participation was abstracted from the qualitative interview.ResultsWe successfully consented 134 patients, slightly more than our target number, in 27 months. Ninety-five of the consented patients enrolled in the study. The enrollment rate among the patients approached was 18% through clinic and 6% through telephone recruitment. The most commonly cited reason for declining study participation given by patients recruited in the clinic was 'Lives Too Far Away'; for patients recruited by telephone it was 'Not Interested in the Study'. One factor that significantly distinguished patients who consented from patients who declined was the distance between their residence and the study site (t-test: p < .001). The most frequently reported reason for study participation was some benefit to the patient him/herself. Other reasons included helping others, being grateful to the VA, positive comments by trusted professionals, certain characteristics of the recruiter, and monetary compensation.ConclusionsThe enrollment rate was low primarily because of travel considerations, but we were able to identify and highlight valuable information for planning recruitment for future similar studies.

ABSTRACT. Objective:To evaluate the full range of alcohol treatment effectiveness, it is important to assess secondary nondrinking outcome dimensions in addition to primary alcohol consumption outcomes. Method: We used a large sample (n = 1,226) of alcoholdependent participants entering the National Institute on Alcohol Abuse and Alcoholism-sponsored COMBINE (Combining Medications and Behavioral Interventions) Study, a multisite clinical trial of pharmacological (naltrexone [ReVia] and acamprosate [Campral]) and behavioral interventions, to examine the effects of specifi c treatment combinations on nondrinking functional outcomes. We assessed the outcomes at baseline and at the end of 16 weeks of alcohol treatment and again at the 26-week and/or 52-week postrandomization follow-ups. Results: (1) Drinking and secondary outcomes were signifi cantly related, especially at the follow-up periods. A higher percentage of heavy drinking days, more drinks per drinking day, and lower percentage of days abstinent were associated with lower quality-of-life measures. (2) All nondrinking outcomes showed improvement at the end of 16 weeks of treatment and most maintained improvement over the 26-week and 52-week followups. Only two measures returned to pretreatment levels at 52 weeks: percentage of days paid for work and physical health. Improvements of nondrinking outcomes remained even after adjusting for posttreatment heavy drinking status. (3) Although nondrinking outcomes showed overall improvement, specifi c pharmacological and behavioral treatment combinations were not differentially effective on specifi c secondary outcomes. Conclusions: In the current study, changes that resulted from treatment were multidimensional, and improvements in nondrinking outcomes refl ected the overall signifi cant improvement in drinking but they were not differentiated between treatment combination groups. Findings from this study support the importance of including secondary nondrinking outcomes in clinical alcohol-treatment trials. (J. Stud. Alcohol Drugs 70: [186][187][188][189][190][191][192][193][194][195][196] 2009)

The effects of aging on alcohol consumption behaviors are unclear because of confounding with period and cohort effects. In 1973, 1,859 male participants in the Normative Aging Study, born between 1892 and 1945, described their drinking behaviors by responding to a mailed questionnaire. In 1982, 1,713 of the participants in this study responded to a similar questionnaire. We used multivariate techniques, adjusting regression coefficients for the correlations between repeated responses of the same individuals, to assess the effects of birth cohort and aging on mean alcohol consumption level, on the prevalence of problems with drinking, and on the prevalence of averaging three or more drinks per day. Older men drank significantly less than younger men at both times yet there IntroductionThe extent to which alcohol consumption behaviors are modified as people age is unclear. National surveys of community-dwelling individuals have consistently found more non-drinkers and fewer heavier and problem drinkers among the elderly than among the young.' Prevalences of problem drinking in national surveys" 2 are highest among men aged 21-34 with rates about 2.5-3.0 times those of men over age 65. From a clinical perspective, age-specific prevalences ofpatients in treatment facilities because of alcoholism are highest in the age-group 40-49 with a rate 3 to 4 times greater than those aged 61-70.3 Suggestions drawn from cross-sectional surveys that aging modifies drinking behaviors are limited because of potential cohort differences, differential mortality and differ-