Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcam

Abstract

BackgroundTrials aimed at preventing cognitive decline through cognitive stimulation among those with normal cognition or mild cognitive impairment are of significant importance in delaying the onset of dementia and reducing dementia prevalence. One challenge in these prevention trials is sample recruitment bias. Those willing to volunteer for these trials could be socially active, in relatively good health, and have high educational levels and cognitive function. These participants’ characteristics could reduce the generalizability of study results and, more importantly, mask trial effects. We developed a randomized controlled trial to examine whether conversation-based cognitive stimulation delivered through personal computers, a webcam and the internet would have a positive effect on cognitive function among older adults with normal cognition or mild cognitive impairment. To examine the selectivity of samples, we conducted a mass mail-in survey distribution among community-dwelling older adults, assessing factors associated with a willingness to participate in the trial.MethodsTwo thousand mail-in surveys were distributed to retirement communities in order to collect data on demographics, the nature and frequency of social activities, personal computer use and additional health-related variables, and interest in the prevention study. We also asked for their contact information if they were interested in being contacted as potential participants in the trial.ResultsOf 1,102 surveys returned (55.1% response rate), 983 surveys had complete data for all the variables of interest. Among them, 309 showed interest in the study and provided their contact information (operationally defined as the committed with interest group), 74 provided contact information without interest in the study (committed without interest group), 66 showed interest, but provided no contact information (interest only group), and 534 showed no interest and provided no contact information (no interest group). Compared with the no interest group, the committed with interest group were more likely to be personal computer users (odds ratio (OR) = 2.78), physically active (OR = 1.03) and had higher levels of loneliness (OR = 1.16).ConclusionIncreasing potential participants’ familiarity with a personal computer and the internet before trial recruitment could increase participation rates and improve the generalizability of future studies of this type.Trial registrationThe trial was registered on 29 March 2012 at ClinicalTirals.gov (ID number NCT01571427).

Web‐enabled conversational interactions as a method to improve cognitive functions: Results of a 6‐week randomized controlled trial

“…The limitations of our study included a selection bias. As shown in our previous study [20] , those who volunteer to participate in such studies differ from the general population. For example, the high adherence we observed could have been in part because the participants were self-selected volunteers.…”

“…Of these, 383 subjects (19.1%) provided contact information ( Figure 1 ). The characteristics associated with those who provided contact information in the survey compared with those who returned the survey without providing the information (potential volunteer bias) have been previously summarized in detail [20] . In brief, those who provided contact information were more likely to be PC users and physically active and to have higher social isolation scores, with PC usage the most significant predictor after controlling for education and other confounders.…”

“…Finally, we included the interaction effect of PC usage (yes/no; the questions are listed in Table 1 ) and the study group (intervention versus control group, with the latter group as a reference) to examine whether the trial efficacy differed by PC usage/experience. This was because our previous study found that those who provided contact information in the survey were significantly more likely to be PC users [20] . If PC users have higher or lower efficacy compared with non-PC users, this information would be useful for generalizing our study results to nonparticipants.…”

“…), and other [write in]). Willingness (yes/no) to participate in the future clinical trial (after a brief explanation of the prevention study protocol) and provide contact information if willing to be contacted (described in detail in Dodge et al [20] ). Baseline interviews (subjects selected from those who had provided contact information in the survey) Demographic information (confirming answers listed in the survey questionnaire) NEO Big-5 personality inventory [21] Geriatric depression scale, 15-item scale [22] Clinical dementia rating scale [23] Informant contact information to complete the clinical dementia rating scale List of current prescription and over the counter medications Neuropsychological assessment (mini mental state examination [24] , category and letter fluency tests [25] , Consortium to Establish a Registry for Alzheimer's Disease word list learning and recall [26] , trail making tests A and B [27] , Stroop test [25] , wide range achievement test-revised [28] , computer assessment of mild cognitive impairment computerized test [29] , 3 subitems from Cogstate computerized test [30] ) Feedback on computerized tests (fatigue, easiness to follow, preference for Computer Assessment of Mild Cognitive Impairment versus Cogstate, after these tests) …”

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“…Furthermore, there may be volunteer bias, where participants in this study may be different from those who chose not to volunteer. 34 All data collected were self-reported; thus, there is a potential for over-or under-reporting as participants may have felt compelled to offer socially desirable responses. 35 This study also has a sampling bias with our sample being predominantly female (80%), limiting generalizability with respect to male protesters.…”