A randomized clinical trial to evaluate home-based assessment of people over 75 years old.

INTRODUCTION: There is an unmet need for effective methods for conducting dementia prevention trials. METHODS: Home-based assessment study compared feasibility and efficiency, ability to capture change over time using in-home instruments, and ability to predict cognitive conversion using predefined triggers in a randomized clinical trial in (1) mail-in questionnaire/live telephone interviews, (2) automated telephone/interactive voice recognition, and (3) internet-based computer Kiosk technologies. Primary endpoint was defined as cognitive conversion. RESULTS: Analysis followed a modified intent-to-treat principle. Dropout rates were low and similar across technologies but participants in Kiosk were more likely to dropout earlier. Staff resources needed were higher in Kiosk. In-home instruments distinguished conversion and stable groups. Cognitively stable group showed improvement in cognitive measures. Triggering was associated with higher likelihood of conversion but statistically significant only in mail-in questionnaire/live telephone interviews. DISCUSSION: Relatively low efficiency of internet-based assessment compared with testing by live-assessors has implications for internet-based recruitment and assessment efforts currently proposed for diverse populations.

Participant satisfaction with dementia prevention research: Results from Home-Based Assessment trial.

INTRODUCTION: Little is known about factors affecting motivation and satisfaction of participants in dementia prevention trials. METHODS: A Research Satisfaction Survey was administered to 422 nondemented older adults who participated in the Home-Based Assessment trial. RESULTS: Overall satisfaction was high, with means of all individual items near to above a value of 3 on a scale from 1 (worst) to 4 (best). Greater satisfaction was associated with staff-administered interviews versus automated technologies. The most liked aspects of research participation were volunteerism, opportunity to challenge and improve mental function, and positive interactions with staff. The least liked aspect was repetitiveness of the assessments. Participants requested more contact with staff and other older adults and more feedback on performance. DISCUSSION: Older adults' participation in research was primarily motivated by altruism. Methodologies that facilitate human contact, encourage feedback and novelty of tasks should be incorporated into future trial design.

Developing dementia prevention trials: baseline report of the Home-Based Assessment study.

This report describes the baseline experience of the multicenter, Home-Based Assessment study, designed to develop methods for dementia prevention trials using novel technologies for test administration and data collection. Nondemented individuals of 75 years of age or more were recruited and evaluated in-person using established clinical trial outcomes of cognition and function, and randomized to one of 3 assessment methodologies: (1) mail-in questionnaire/live telephone interviews [mail-in/phone (MIP)]; (2) automated telephone with interactive voice recognition; and (3) internet-based computer Kiosk. Brief versions of cognitive and noncognitive outcomes were adapted to each methodology and administered at baseline and repeatedly over a 4-year period. "Efficiency" measures assessed the time from screening to baseline, and staff time required for each methodology. A total of 713 individuals signed consent and were screened; 640 met eligibility and were randomized to one of 3 assessment arms; and 581 completed baseline. Dropout, time from screening to baseline, and total staff time were highest among those assigned to internet-based computer Kiosk. However, efficiency measures were driven by nonrecurring start-up activities suggesting that differences may be mitigated over a long trial. Performance among Home-Based Assessment instruments collected through different technologies will be compared with established outcomes over this 4-year study.

Pilot study to show the feasibility of a multicenter trial of home-based assessment of people over 75 years old.

UNLABELLED: This report describes a pilot study to evaluate feasibility of new home-based assessment technologies applicable to clinical trials for prevention of cognitive loss and Alzheimer disease. METHODS: Community-dwelling nondemented individuals >or=75 years old were recruited and randomized to 1 of 3 assessment methodologies: (1) mail-in questionnaire/ live telephone interviews (MIP); (2) automated telephone with interactive voice recognition (IVR); and (3) internet-based computer Kiosk (KIO). Brief versions of cognitive and noncognitive outcomes were adapted to the different methodologies and administered at baseline and 1-month. An Efficiency measure, consisting of direct staff-to-participant time required to complete assessments, was also compared across arms. RESULTS: Forty-eight out of 60 screened participants were randomized. The dropout rate across arms from randomization through 1-month was different: 33% for KIO, 25% for IVR, and 0% for MIP (Fisher Exact Test P=0.04). Nearly all participants who completed baseline also completed 1-month assessment (38 out of 39). The 1-way ANOVA across arms for total staff-to-participant direct contact time (ie, training, baseline, and 1-month) was significant: F (2,33)=4.588; P=0.017, with lowest overall direct time in minutes for IVR (Mn=44.4; SD=21.5), followed by MIP (Mn=74.9; SD=29.9), followed by KIO (Mn=129.4; SD=117.0). CONCLUSIONS: In this sample of older individuals, a higher dropout rate occurred in those assigned to the high-technology assessment techniques; however, once participants had completed baseline in all 3 arms, they continued participation through 1 month. High-technology home-based assessment methods, which do not require live testers, began to emerge as more time-efficient over the brief time of this pilot, despite initial time-intensive participant training.

Improved psychological status in a modified therapeutic community for homeless MICA men.

An adaptation of the drug-free therapeutic community (TC) model to homeless men with comorbid mental illness and chemical addiction (MICA) was evaluated with respect to change in psychological status over the course of a six-month residential treatment. Psychological status was assessed by: the Symptom Checklist-90-R (SCL90-R), Beck Depression Inventory (BDI), Shortened Manifest Anxiety Scale (SMAS), and Tennessee Self-Concept Scale (TSCS). A total of 52 out of an original study cohort of 124 residents were followed in longitudinal analyses to treatment midpoint, with a subset of 34 assessed through treatment completion. Significant, widespread psychological improvements were found during both the first and second half of treatment; it would appear that distress reduction was ongoing throughout treatment, with intrapersonal preceding interpersonal relief. The premise of applying a socially-based treatment to this population is discussed in light of these findings.

Schizophrenic Patients and Cocaine Use: Antecedents to Hospitalization and Course of Treatment.

This study was designed to assess whether cocaine abuse was associated with a different set of antecedents and course for hospitalized schizophrenic patients. Forty-three cocaine-using and 27 non-cocaine-using patients with schizophrenia admitted to a dual diagnosis unit were compared with regard to antecedents to hospitalization such as prior treatment episodes, reliance on drugs for pleasure and tension reduction, and criminal history as well as course of hospital treatment. Cocaine-using patients were more likely to have had a history of prior inpatient drug treatment and to rely on drugs to a greater extent for tension reduction and pleasure. There was a trend for cocaine users to have a history of arrests for violent crimes. Although cocaine-using patients exhibited lower levels of global distress during the first week of hospitalization, they were no different from their counterparts who abused nonpsychostimulant drugs with regard to outcome of hospital treatment. These findings suggest that the lifetime course of illness among schizophrenic patients presenting for hospitalization who abuse cocaine may be characterized by episodes of repeated inpatient drug treatment and impaired impulse control. More rigorous discharge planning and aftercare program monitoring in the community as well as stress management interventions directed to tension reduction are therefore warranted.

Spanish instrument protocol: new treatment efficacy instruments for Spanish-speaking patients in Alzheimer disease clinical trials.

OBJECTIVE: To evaluate the feasibility of longitudinal assessment and the psychometric properties of both established and new outcome measures used in clinical trials of patients with dementia in a cohort of Spanish-speaking elders in the United States. METHODS: This is a prospectively collected multicenter study comparing patients with Alzheimer disease (AD) (N=77) and elderly controls (N=17) who are primary Spanish speakers. Spanish-speaking individuals with AD (SSI AD) were selected to represent predefined categories of impairment as determined by a Mini-Mental State Examination score. Controls were selected to approximately match by age and education (SSI C). Subjects were administered a series of Spanish translations of established outcome measures (Mini-Mental State Examination, Clinical Dementia Rating, Geriatric Dementia Scale), and Functional Assessment Staging (FAST)] and new outcome measures developed for United States in clinical trials to assess cognition, function, behavioral disturbance, and clinical global change. Half of the subjects were assessed at 1 and 2 months to evaluate reliability; all subjects were assessed at 6 and 12 months. Comparisons were made between patients and controls and between the Spanish-speaking cohort and a similar English-speaking cohort. RESULTS: The 12-month completion rate was 77%, with a trend toward greater impairment in those with full retention. Both established and new measures demonstrated good internal consistency and test-retest reliability in this cohort. All but one measure of cognition demonstrated excellent discriminability between AD subjects and controls. The SSI AD cohort declined significantly on measures of cognition, function, and clinical global change over the 12-month assessment period. The SSI AD and English AD (ESI AD) cohorts declined equivalently on the most common outcomes in clinical trials of AD (delayed recall, clinical global change). Likewise, the most common behavioral changes were also similar in the ESI and SSI groups. However, the annual change was lower in SSI AD than in the ESI AD on several other measures of cognition and function. CONCLUSIONS: These results support the recruitment of Spanish-speaking patients and the use of Spanish language translations for use in the clinical trials for AD.

A pilot study of vitamins to lower plasma homocysteine levels in Alzheimer disease.

OBJECTIVE: Authors determined the impact of high-dose vitamin supplements on plasma homocysteine levels in patients with Alzheimer disease (AD). METHODS: Authors used an open-label trial of folic acid, vitamin B(12), and vitamin B(6), in combination for 8 weeks, with measurement of plasma homocysteine levels in the fasting state and after methionine-loading. A total of 69 subjects with AD were enrolled, including 33 who were taking standard multivitamin supplements; 66 were available at 8-week follow-up. RESULTS: The high-dose vitamin regimen was associated with a significant reduction in fasting and post-methionine-loading homocysteine. Reductions were greater in the subgroup not using multivitamins, but were also significant in the multivitamin users. CONCLUSION: High-dose vitamin supplementation reduces homocysteine levels in patients with AD. The effect of supplementation on rate of cognitive decline will be assessed later in a randomized, double-blind study.