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Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study.

ABSTRACT: BACKGROUND:Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. OBJECTIVE:The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. METHODS:This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. RESULTS:In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. CONCLUSIONS:This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv).

SUBMITTER: Smith G

PROVIDER: S-EPMC5725623 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study.

Smith Glenn G Chandler Melanie M Locke Dona Ec DE Fields Julie J Phatak Vaishali V Crook Julia J Hanna Sherrie S Lunde Angela A Morris Miranda M Graff-Radford Michelle M Hughes Christine A CA Lepore Susan S Cuc Andrea A Caselli Maria M Hurst Duane D Wethe Jennifer J Francone Andrea A Eilertsen Jeanne J Lucas Pauline P Hoffman Snyder Charlene C Kuang LeeAnn L Becker Marigrace M Dean Pamela P Diehl Nancy N Lofquist Marvin M Vanderhook Shirley S Myles Diana D Cochran Denise D

JMIR research protocols 20171127 11

<h4>Background</h4>Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective.<h4>Objective</h4>The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners.<h4>Methods</h4>This protocol describes a comparative effectiveness trial targeting 300 participants with mild c ...[more]

PMID: 29180344

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Project description:OBJECTIVES:IN THIS PAPER WE AIM TO: (1) identify and review midlife risk factors that may contribute to the development of dementia and that may be amenable to intervention; (2) review advances made in our understanding of the most common cause of dementia, Alzheimer's disease (AD), where current pharmacological studies have aimed to modify the disease course; and (3) explore other interventions that may slow cognitive decline in those with AD. METHODS:A review of the literature was conducted to look for interventions that may modify the risk of incident dementia or that may modify symptom progression in those with diagnosed dementia. RESULTS:(1) Midlife risks identified as amenable to intervention include blood pressure, diabetes, elevated cholesterol, poor psychosocial and lifestyle factors. (2) The leading drugs in development can be grouped by their principal target: anti-amyloid, anti-tau and mitochondrial stability. However to date, there have been no successes in late stage Phase III trials of putative disease-modifying drugs for AD. (3) Once the diagnosis of dementia has been made there is little that can slow the rate of decline. Possible exceptions include the use of exercise and antihypertensive medication with some nootropic medication showing promise in small trials. CONCLUSION:(1) It is clear that there are several risk factors in midlife that may lead to a greater likelihood of developing dementia. However, there is no simple intervention to modify these risks. It seems sensible to conclude from the data that avoiding high blood pressure, controlling cholesterol and diabetes as well as maintaining a healthy diet and lifestyle may lower the risk of developing dementia. (2) The need for better outcome measures in clinical trials is evident and may, in part, explain the numerous failures in late-stage clinical trials of disease-modifying drugs. Improved diagnostic test batteries to reduce population heterogeneity in early intervention studies will be required for robust clinical trials in the future. (3) Current research indicates that there is little that can delay decline; however, future trials may wish to focus on nootropics.

Project description:A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care.A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit.This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs.United States Clinical Trials Registry NCT01177176.

Project description:Dementia affects over 4 million people in the US and is frequently unrecognized and underdiagnosed in primary care. Routine dementia screening in primary care is not recommended by the US Preventive Services Task Force due to lack of empirical data on the benefits and harms of screening. This trial seeks to fill this gap and contribute information about the benefits, harms, and costs of routine screening for dementia in primary care.Single-blinded, parallel, randomized controlled clinical trial with 1:1 allocation. A total of 4,000 individuals aged ?65 years without a diagnosis of dementia, cognitive impairment, or serious mental illness receiving care at primary care practices within two cities in Indiana. Subjects will be randomized to either i) screening for dementia using the Memory Impairment Screen Telephone version or ii) no screening for dementia. Subjects who screen positive for dementia will be referred to the local Aging Brain Care program that delivers an evidence-based collaborative care model for dementia and depression. Research assistants will administer the 15-item Health Utility Index, Patient Health Questionnaire, Generalized Anxiety Disorder Scale, and Medical Outcomes Study at baseline, 1, 6, and 12 months. Information about advanced care planning will be collected at baseline and 12 months. All enrollees' medical records will be reviewed to collect data on health care utilization and costs.We have two primary hypotheses; first, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will have a higher health-related quality of life as measured by the Health Utility Index at 12 months post-screening. Second, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will not have higher depression or anxiety at one month post-screening as measured by the Patient Health Questionnaire and Generalized Anxiety Disorder Scale scales. Our secondary hypothesis is that screened subjects will have an Incremental Cost-Effectiveness Ratio below the maximum acceptable threshold of $60,000 per quality adjusted life year saved at 12 months.Ongoing; registered on September 19, 2012. ClinicalTrials.gov Identifier: 2012 NCT01699503.

Project description:BackgroundAnxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention.Methods/designThe present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure.DiscussionThe present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services.Trial registrationClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

Project description:ImportanceRecommendations to engage in behavioral strategies to combat clinically significant cognitive and behavioral symptoms are routinely given to persons with mild cognitive impairment (MCI). The comparative effectiveness of these behavioral interventions is not well understood.ObjectiveTo compare the incremental effects of combinations of 5 behavioral interventions on outcomes of highest importance to patients with MCI.Design, setting, and participantsIn this multisite, cluster randomized, multicomponent comparative effectiveness trial, 272 patients from 4 academic medical outpatient centers (Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Scottsdale, Arizona; Mayo Clinic, Jacksonville, Florida; and University of Washington, Seattle) were recruited from September 1, 2014, to August 31, 2016, with last follow-up March 31, 2019. All participants met the National Institute on Aging-Alzheimer's Association criteria for MCI.InterventionsThe intervention program was modeled on the Mayo Clinic Healthy Action to Benefit Independence and Thinking (HABIT) program, a 50-hour group intervention conducted during 2 weeks, including memory compensation training, computerized cognitive training, yoga, patient and partner support groups, and wellness education. In our study, 1 of 5 interventions was randomly selected to be withheld for each intervention group. Participants and their partners had 1-day booster sessions at 6 and 12 months after intervention.Main outcomes and measuresQuality-of-life measurement of participants with MCI at 12 months was the primary outcome, selected based on the preference rankings of previous program participants. Mood, self-efficacy, and memory-based activities of daily living were also highly ranked.ResultsA total of 272 participants (mean [SD] age, 75 [8] years; 160 [58.8%] male and 112 [41.2%] female) were enrolled in this study, with 56 randomized to the no yoga group, 54 to no computerized cognitive training, 52 to no wellness, 53 to no support, and 57 to no memory support system. The greatest effect size for quality of life was between the no computerized cognitive training and no wellness education groups at 0.34 (95% CI, 0.05-0.64). In secondary analyses, wellness education had a greater effect on mood than computerized cognitive training (effect size, 0.53; 95% CI, 0.21-0.86), and yoga had a greater effect on memory-related activities of daily living than support groups (effect size, 0.43; 95% CI, 0.13-0.72).Conclusions and relevanceThese results provide further support for behavioral interventions for persons with MCI. Different outcomes were optimized by different combinations of interventions. These findings provide an initial exploration of the effect of behavioral interventions on patient-advocated outcomes in persons with MCI.Trial registrationClinicalTrials.gov identifier: NCT02265757.

Project description:BackgroundRural Americans have higher prevalence of obesity and type 2 diabetes (T2D) than urban populations and more limited access to behavioral programs to promote healthy lifestyle habits. Descriptive evidence from the Rural Lifestyle Intervention Treatment Effectiveness trial delivered through local cooperative extension service offices in rural areas previously identified that behavioral modification with both nutrition education and coaching resulted in a lower program delivery cost per kilogram of weight loss maintained at 2-years compared with an education-only comparator intervention.ObjectiveThis analysis extended earlier Rural Lifestyle Intervention Treatment Effectiveness trial research regarding weight loss outcomes to assess whether nutrition education with behavioral coaching delivered through cooperative extension service offices is cost-effective relative to nutrition education only in reducing T2D cases in rural areas.DesignA cost-utility analysis was conducted.Participants/settingTrial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy.InterventionTrial participants were randomly assigned to low, moderate, or high doses of behavioral coaching with nutrition education (ie, 16, 32, or 48 sessions over 24 months) or a comparator intervention that included 16 sessions of nutrition education without coaching. Participant glycated hemoglobin level was measured at baseline and the end of the trial to assess T2D status.Main outcome measuresT2D categories by treatment arm were used to estimate participants' expected annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon. Discounted incremental costs and QALYs were used to calculate incremental cost-effectiveness ratios for each behavioral coaching intervention dose relative to the education-only comparator.Statistical analyses performedUsing a third-party payer perspective, Markov transition matrices were used to model participant transitions between T2D states. Replications of the individual participant behavior were conducted using Monte Carlo simulation.ResultsAll three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator. The moderate dose behavioral coaching intervention was associated with higher estimated QALYs but was costlier than the low dose; the moderate dose was favored over the low dose with willingness to pay thresholds over $107,895/QALY. The low dose behavioral coaching intervention was otherwise favored.ConclusionsBecause most rural Americans live in counties with cooperative extension service offices, nutrition education with behavioral coaching programs similar to those delivered through this trial may be effective and efficient in preventing or delaying T2D-associated consequences of obesity for rural adults.

Project description:IntroductionDelirium is a common, serious and potentially preventable condition with devastating impact on the quality of life prompting a proliferation of interventional trials. Core outcome sets aim to standardise outcome reporting by identifying outcomes perceived fundamental for measurement in trials of a specific interest area. Our aim is to develop international consensus on two core outcome sets for trials of interventions to prevent and/or treat delirium, irrespective of study population. We aim to identify additional core outcomes specific to the critically ill, acutely hospitalised patients, palliative care and older adults.Methods and analysisWe will conduct a systematic review of published and ongoing delirium trials (1980 onwards) and one-on-one interviews of patients who have experienced delirium and family members. These data will inform Delphi round 1 of a two-stage consensus process. In round 2, we will provide participants their own response, summarised group responses and those of patient/family participants for rescoring. We will randomise participants to receive feedback as proportion scoring the outcome as critical or as group mean responses. We will hold a consensus meeting using nominal group technique to finalise outcomes for inclusion. We will repeat the Delphi process and consensus meeting to select measures for each core outcome. We will recruit 240 Delphi participants giving us 80% power to detect a 1.0-1.5 point (9-point scale) difference by feedback method between rounds. We will analyse differences for subsequent scores, magnitude of opinion change, items retained and level of agreement.Ethics and disseminationWe are obtaining research ethics approvals according to local governance. Participation will be voluntary and data deidentified. Support from three international delirium organisations will be instrumental in dissemination and core outcome set uptake. We will disseminate through peer-reviewed open access publications and present at conferences selected to reach a wide range of knowledge users.

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Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study.

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Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study.

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