An Online, Person-Centered, Risk Factor Management Program to Prevent Cognitive Decline: Protocol for A Prospective Behavior-Modification Blinded Endpoint Randomized Controlled Trial

2021 ◽  
pp. 1-20
Author(s):  
Yen Ying Lim ◽  
Darshini Ayton ◽  
Stephanie Perin ◽  
Alexandra Lavale ◽  
Nawaf Yassi ◽  
...  

Background: Several modifiable risk factors for dementia have been identified, although the extent to which their modification leads to improved cognitive outcomes remains unclear. Objective: The primary aim is to test the hypothesis that a behavior modification intervention program targeting personalized risk factors prevents cognitive decline in community-dwelling, middle-aged adults with a family history of dementia. Methods: This is a prospective, risk factor management, blinded endpoint, randomized, controlled trial, where 1510 cognitively normal, community-dwelling adults aged 40–70 years old will be recruited. Participants will be screened for risk factors related to vascular health (including physical inactivity), mental health, sleep, and cognitive/social engagement. The intervention is an online person-centered risk factor management program: BetterBrains. Participants randomized to intervention will receive telehealth-based person-centered goal setting, motivational interviewing, and follow-up support, health care provider communication and community linkage for management of known modifiable risk factors of dementia. Psychoeducational health information will be provided to both control and intervention groups. Results: The primary outcome is favorable cognitive performance at 24-months post-baseline, defined as the absence of decline on one or more of the following cognitive tests: (a) Cogstate Detection, (b) Cogstate One Card Learning, (c) Cogstate One Back, and (d) Cognitive Function Instrument total score. Conclusion: We will test the hypothesis that the BetterBrains intervention program can prevent cognitive decline. By leveraging existing community services and using a risk factor management pathway that tailors the intervention to each participant, we maximize likelihood for engagement, long-term adherence, and for preserving cognitive function in at-risk individuals.

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 811-811
Author(s):  
Jennifer Deal ◽  
Nicholas Reed ◽  
David Couper ◽  
Kathleen Hayden ◽  
Thomas Mosley ◽  
...  

Abstract Hearing impairment in older adults is linked to accelerated cognitive decline and a 94% increased risk of incident dementia in population-based observational studies. Whether hearing treatment can delay cognitive decline is unknown but could have substantial clinical and public health impact. The NIH-funded ACHIEVE randomized controlled trial of 977 older adults aged 70-84 years with untreated mild-to-moderate hearing loss, is testing the efficacy of hearing treatment versus health education on cognitive decline over 3 years in community-dwelling older adults (Clinicaltrials.gov Identifier: NCT03243422.) This presentation will describe lessons learned from ACHIEVE’s unique study design. ACHIEVE is nested within a large, well-characterized multicenter observational study, the Atherosclerosis Risk in Communities Study. Such nesting within an observational study maximizes both operational and scientific efficiency. With trial results expected in 2022, this presentation will focus on the benefits gained in design and recruitment/retention, including dedicated study staff, well-established protocols, and established study staff-participant relationships. Part of a symposium sponsored by Sensory Health Interest Group.


Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Seamus P Whelton ◽  
Khurram Nasir ◽  
Michael J Blaha ◽  
Daniel S Berman ◽  
Roger S Blumenthal

Introduction: Non-invasive cardiovascular imaging has been proposed as a method to improve risk stratification and motivate improved patient and physician risk factor modification. Despite increasing use of these technologies there remains limited evidence documenting its effect on downstream testing and improvement in risk factor control. Hypothesis: Addition of the EISNER study to a prior meta-analysis will improve statistical power to demonstrate the downstream consequences of non-invasive cardiovascular imaging. Methods: A comprehensive literature search of the MEDLINE database (1966 through July 2011) was conducted. Major inclusion criteria required: 1) randomized controlled trial design, 2) participants with no known history of coronary heart disease or stroke, and 3) comparison of a group provided with results of a non-invasive imaging scan versus those without results. A total of eight trials with 4,084 participants met the inclusion criteria for this analysis. We analyzed the data using a random effects model to allow for heterogeneity. Results: Among imaging groups there was a significant increase in prescribing for statins (RR, 1.15; 95% CI, 1.01–1.32) and a non-significant trend for increased prescription of aspirin (RR, 1.15; 95% CI, 0.97–1.35), ACE/ARB (RR, 1.12; 95% CI, 0.96–1.31), and insulin (RR, 1.54; 95% CI, 0.75–3.18). There was a non-significant trend towards increased smoking cessation (RR, 1.35; 95% CI, 0.88–2.08). For downstream outcomes there was a non-significant increase in coronary angiography (RR, 1.20; 95% CI, 0.92–1.57), but not for revascularization (RR, 0.92; 95% CI, 0.55–1.53). There was no significant effect of imaging on the change in traditional risk factors. Limitations: There remains a limited number of trials in this important area. Therefore, trials included in this analysis use a variety of different imaging modalities and we were not able to pool the results based on appropriate clinical action (intensification at high risk and reduction at low risk). Conclusions: Non-invasive cardiovascular imaging leads to increased statin use, but associations with other downstream treatments and change in risk factors are not statistically significant. Our results highlight the limited amount of data for describing the downstream consequences after CAC testing.


2019 ◽  
Vol 19 (10) ◽  
pp. 1386-1394 ◽  
Author(s):  
Agustín Aibar-Almazán ◽  
Antonio Martínez-Amat ◽  
David Cruz-Díaz ◽  
Manuel J. De la Torre-Cruz ◽  
José D. Jiménez-García ◽  
...  

2020 ◽  
Author(s):  
Werayuth Srithum ◽  
Mai Kabayama ◽  
Yasuyuki Gondo ◽  
Yukie Masui ◽  
Yuya Akagi ◽  
...  

Abstract Background: Cognitive impairment is a major health concern among older and oldest people.Moreover, stroke is a relevant contributor for cognitive decline and development of dementia. The study of cognitive decline focused on stroke as the important risk factor by recruiting older and oldest is still lagging behind. Therefore, the aim of this study was to investigate the importance of stroke as a risk factor of cognitive decline during three years in community dwelling older and oldest people. Methods: This study was longitudinal study with a 3-year follow-up in Japan. The participants were 1,333community dwelling older and oldest people (70 years old = 675, 80 years old = 589, and 90 years old = 69). Data collected included basic data (age, sex, and history of stroke), vascular risk factors (hypertension, diabetes mellitus, dyslipidemia, atrial fibrillation, and current smoking), and social factors (educational level, frequency of going outdoors, long-term care (LTC) service used, and residential area). The Japanese version of the Montreal Cognitive Assessment (MoCA-J) was decline of ≥ 2 points was defined as cognitive decline. Multiple logistic regression analysis was used to investigate the association between stroke and other risk factors with cognitive decline during a 3-year follow-up. Results: The fit of the hypothesized model by multiple logistic regression showed that a history of stroke, advanced age, and greater MoCA-J score at the baseline were important risk factors, while the presence of dyslipidemia and a higher educational level were protective factors that were significantly correlated with cognitive decline during the 3-year follow-up. Conclusions: The cognitive decline after the 3-year follow-up was influenced by the history of stroke and advanced age, while greater MoCA-J score at the baseline was positively associated with subsequent 3 years cognitive decline. The protective factors were the presence of dyslipidemia and a higher educational level. Therefore, these factors are considered important and should be taken into consideration when searching for creative solutions to prevent cognitive decline after stroke in community dwelling older and oldest people.


Circulation ◽  
2016 ◽  
Vol 133 (suppl_1) ◽  
Author(s):  
Muideen T Olaiya ◽  
Dominique A Cadilhac ◽  
Joosup Kim ◽  
Mark R Nelson ◽  
Velandai K Srikanth ◽  
...  

Introduction: Clinical guidelines for patients with stroke or TIA have focused on modification of lifestyle and treatment to achieve cardometabolic risk factor goals. However, there is limited evidence on effective attainment of these goals in this high-risk population. Hypothesis: We hypothesised that a one-year intervention program will improve the attainment of cardiometabolic risk factor goals in community-dwelling survivors of stroke or TIA. Methods: Shared Team Approach between Nurses and Doctors For Improved Risk Factor Management (STANDFIRM) trial is an on-going prospective, randomised controlled trial of risk factor management in people with stroke or TIA. Patients hospitalised for stroke/TIA, and aged ≥18 years, were provided an intervention comprising an individualised, evidence-based secondary prevention program, including nurse education visits, and management plan with specialist oversight. The study outcome was attainment of blood pressure, blood cholesterol, blood sugar, body composition, kidney function goals, and smoking cessation at 12 months, based on guideline recommendations. We assessed whether lifestyle or other factors were associated with achieving an increased number of goals. Data collection comprised surveys, anthropometric and biochemical measurements. Differences in the proportion of patients meeting the set goals at baseline and 12 months were determined using McNemar’s chi-square test. The association between baseline factors and goal attainment was determined using multivariable linear regression. Results: Between January 2010 and November 2013, 233 patients (66% male, median age 69 years, 77% ischaemic stroke) were recruited into the intervention arm of the trial. Between baseline and 12 months, there was no difference in the proportion of patients achieving each of the set goals. Overall, only 14 patients (3%) achieved all six measured goals. A total of 90 patients (34%) met ≥4 goals, 89 (34%) met 3 goals, and 84 (32%) met ≤2 goals. In multivariable analyses, factors independently associated with achieving more goals included being female (OR 1.70, 95% CI 1.27, 2.20), having vocational or higher education (OR 1.37, 95% CI 1.05, 1.80), and lower salt intake at baseline (OR 0.98, 95% CI 0.97, 1.00). Conclusion: The 12-month intervention did not have an impact on the attainment of cardiometabolic goals in patients with stroke or TIA. With few individual factors identified, further investigation of system-level factors is warranted to ascertain factors that could facilitate improved risk factor management in patients with stroke or TIA.


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