A personal coaching intervention led to modest cognitive improvements in older adults at high risk for dementia, the SMARRT pilot trial showed.
After 2 years, the intervention group improved more on the cognitive primary outcome than the control group, showing an average treatment effect of 0.14 (95% CI 0.03-0.25, P=0.02), reported Kristine Yaffe, MD, of the University of California San Francisco, and co-authors.
This represented a 74% improvement compared with change in the control group, Yaffe and colleagues wrote in . The average treatment effect estimate was similar to Cohen's d and was consistent with a small clinical effect, they noted.
"This is the first personalized risk reduction trial that has been conducted to slow cognitive decline or prevent Alzheimer's disease," Yaffe told 鶹ý.
"The fact that we found a positive effect of our intervention -- despite the study being conducted during the COVID-19 pandemic and not having a super large sample -- suggests that this may be an important strategy for older adults to maintain cognitive function," she continued.
Personal coaching may be more effective than a one-size-fits-all approach, Yaffe observed.
"There is a lot of interest in modifying risk factors in hopes of reducing Alzheimer's risk but few studies have shown this in a gold-standard randomized clinical trial," she said. "We did that. The study hugely adds to risk reduction ideas that were mostly theoretical up until this point."
About 40% of dementia cases may be prevented or delayed by modifying 12 risk factors, according to a 2020 Lancet Commission report.
Most research about dementia risk factors has been observational, but in 2015 the suggested a multidomain intervention could improve or maintain cognitive functioning in at-risk older adults in Finland. Modified FINGER interventions are being tested in the ongoing , which will be completed in 2025.
The enrolled 172 adults from Kaiser Permanente Washington primary care clinics with a mean baseline age of 76. Participants had at least two of eight dementia risk factors: physical inactivity, uncontrolled hypertension, uncontrolled diabetes, poor sleep, prescription medications associated with cognitive risk, high depressive symptoms, social isolation, or current smoking. Data were collected from August 2018 to August 2022.
People living in a skilled nursing facility, receiving hospice care, or with dementia at baseline were excluded. Participants were randomly assigned to a personalized risk-reduction intervention program with a health coach and nurse (82 people) or to a health education control group (90 people).
In the intervention group, participants selected risk-reduction goals and worked with coaches every 4 to 6 weeks, with 45-minute sessions during the first 3 months and 20-minute sessions after that. Coaching sessions were switched from in-person to telephone as the pandemic emerged. Every 3 months, a nurse contacted participants who had uncontrolled diabetes or hypertension or who used cognitively risky medications.
During the trial, the intervention group worked on an average of 3.5 dementia risk factors, most commonly physical inactivity (95.1%), hypertension (67.1%), sleep (52.4%), depressive symptoms (45.1%), and social engagement (41.5%).
In the control group, participants received educational materials about dementia risk reduction by mail every 3 months. Controls had a similar age to the intervention group but had fewer female participants.
All participants had a baseline in-person visit, but follow-up at 6, 12, 18, and 24 months included telephone assessments due to the pandemic. The primary outcome was a composite z score based on the modified Neuropsychological Test Battery, which incorporated the telephone test of global cognition plus verbal memory, attention, and language assessments.
Secondary outcomes included a composite z score for risk factors, which improved in the intervention group compared with controls (average treatment effect of 0.11, 95% CI 0.01-0.20, P=0.03) after 24 months. Quality of life, another secondary outcome, trended favorably for the intervention group (average treatment effect 0.81 points, 95% CI -0.21 to 1.84, P=0.12).
While there were no between-group differences in serious adverse events, the intervention group had greater treatment-related musculoskeletal pain (14 people in the intervention group vs 0 in the control group, P<0.001).
The study was conducted at one site and wasn't powered to detect small treatment effects in individual risk factors or incident mild cognitive impairment or dementia, Yaffe and co-authors acknowledged. The intervention group had ongoing communication with coaches and nurses; this social contact may have influenced cognitive outcomes, they added.
Disclosures
This study was supported by the National Institute on Aging of the NIH.
Yaffe reported relationships with the NIH, Alector, the Global Council on Brain Health, and Alpha Cognition. Co-authors reported relationships with the NIH, GSK, Syneos Health, Together Senior Health, and the CDC.
Primary Source
JAMA Internal Medicine
Yaffe K, et al "Effect of personalized risk-reduction strategies on cognition and dementia risk profile among older adults: The SMARRT randomized clinical trial" JAMA Intern Med 2023; DOI: 10.1001/jamainternmed.2023.6279.