Counterintuitive Findings for Novel Intervention in Dementia

A comprehensive, home-based intervention providing hearing and vision support did not show a statistically significant improvement in quality of life for patients living with dementia and their caregivers, preliminary results of a pan-European randomized controlled trial (RCT) show.

The results are “unexpected and counterintuitive, giving us lots to ponder as we work to understand these results in more detail; informal feedback from participants and sensory therapists after the trial ended told a very different story,” chief investigator Iracema Leroi, MD, told Medscape Medical News.

Leroi, associate professor of geriatric psychiatry, Trinity College Dublin, Dublin, Ireland, cautioned that there were multiple COVID-related study amendments, which may have had an impact on the results.

Leroi presented results of the SENSE-Cog RCT at the Alzheimer’s Association International Conference (AAIC) 2022.

Hidden Contributing Factor

Hearing and vision problems are common, and often underrecognized and insufficiently managed in people living with dementia (PwD).

Sensory impairment in the setting of dementia may lead to more rapid cognitive and functional decline, contribute to challenging behaviors, as well as depression, communication barriers, greater dependency, and caregiver burden.

Together, these factors may culminate in reduced quality of life for patients and care partners. Thus, the researchers anticipated that addressing hearing and vision problems, such as through the trial intervention, might improve quality of life.

In an initial 12-week pilot trial, a multipart “sensory support” intervention (SSI) was effective in improving quality of life and other key outcomes in 19 PwD (including hearing and/or vision problems) and their care partners, and provided support for conducting the large-scale RCT in five countries with over 250 people with dementia and their care partners.

The SSI included assessment and correction of hearing and/or vision impairments, home-based, therapist-delivered sensory support targeting adherence with devices, improving the sensory environment, communication training, and referral to other support agencies.

In the SENSE-cog RCT, participants had a median age of 80 years, 53% were women, 60% had only hearing impairment, 4% had only visual impairment, and 37% had both hearing and vision impairment. They were randomly allocated to the intervention (10 visits over 18 weeks) or usual care.

In contrast to results of the initial pilot trial, in the SENSE-cog RCT no significant difference in quality-of-life (QoL) scores (the primary outcome) at 36 weeks was observed.

Secondary outcomes of the trial — QoL at 18 weeks, hearing-related QoL, function (Bristol Activities of Daily Living Scale), cognition (Montreal Cognitive Assessment), behavior (Neuropsychiatric Inventory), and relationship satisfaction — were not reported at the conference.

Leroi said the trial is now complete and the final analysis is in progress, with the results likely to be ready for submission at the end of September.

Disappointing Results

Reached for comment, Shaheen E. Lakhan, MD, PhD, a neurologist and researcher from Boston, Massachusetts, who wasn’t involved in the analysis, noted that “problems with hearing and visual disturbances and their impact on quality of life rise with advancing age.”

When diagnosing dementia, it’s important to test hearing and vision “to make sure these are not masquerading as dementia or worsening underlying dementia,” Lakhan told Medscape Medical News.

“Imagine slowly progressive problems with your hearing and/or vision over years to decades — it leads to poor communication, social isolation, depression, increased fall risk, lack of physical activity, and, ultimately, impaired functioning and disability,” Lakhan said.

“The SENSE-cog trial results are disappointing for home-based hearing and vision interventions in patients with dementia.” However, it would be premature to “throw sensory support out the window,” he said.

Lakhan said future studies in this area “must incorporate more passive sensing technologies — that is, gathering data behind the scenes without explicit patient input through, for example, sensors on the smartphone regarding sleep, movement, social integration, communications, voice, and many other functions.”

The study was funded by a Horizon 2020 grant from the European Commission (grant agreement No 668648) and coordinated by EUCLID at the University of Bordeaux, Bordeaux, France. Leroi and Lakhan reported no relevant disclosures.

Alzheimer’s Association International Conference (AAIC) 2022. Abstract # 62722. Presented Aug. 2, 2022.

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