A Lifestyle Intervention Study to Reduce Modifiable Risk Factors for Dementia in People with Mild Cognitive Impairment - The COAST Study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: The COAST study will use three intervention groups, each designed to reduce modifiable risk factors for dementia. The three interventions will vary in intervention intensity level, with Group 1 being low intensity, Group 2 being moderate intensity, and Group 3 being high intensity. All participants will set SMART goals for dementia risk reduction behaviour change with an experienced psychologist at the Healthy Brain Ageing (HBA) clinic located at the Sunshine Coast Mind and Neuroscience ‐ Thompson Institute (SCMN‐TI) prior to group randomisation. Group 1 ‐ Low intensity (n=30): A dementia risk information only active control group consisting of a comprehensive feedback report of participant's dementia risk profile as determined by comprehensive assessments conducted by experienced medical practitioner, neuropsychologist, and psychologist at the HBA clinic to participants' referring doctor. This report will be written by the HBA clinical psychologist or clinical neuropsychologist, as per standard clinical practice. In addition, individuals will be offered a 45‐min appointment with a research psychologist to discuss dementia risk factors and possible risk reduction strategies. Group 2 ‐ Medium intensity (n=30): A comprehensive feedback report outlining dementia risk will be given to the participant and GP, and participants will also be offered a 45‐min appointment with a research psychologist to discuss dementia risk factors and possible risk reduction strategies (as per Group 1). In addition, participants will receive 10 weeks of text message alerts (sent weekly) regarding healthy brain ageing strategies and recommendations in order to assist participants to achieve their personalised behavior‐change goals (n=30). Text messages will be personalised to each participants' goals as identified in the SMART goal setting interview conducted with the psychologist. Text message content will be selected from a pre‐set menu of messages related to di CONDITION: Mild cognitive impairment; ; Mild cognitive impairment Neurological ‐ Dementias PRIMARY OUTCOME: Feasibility of acceptability: ; ; • % of trial completers. ; ; Acceptability will be defined by 60% completion rate.; Intervention completion for Group 3 is defined as attendance of at least 75% of prescribed intervention sessions and attendance at post‐intervention follow‐up assessment. ; [At 6‐months, acceptability will be reviewed and if the above criteria are not met, the trial will be modified] Feasibility of recruitment. ; ; • % of eligible people agreeing to participate in the trial. ; ; Feasibility will be defined by a 50% uptake in trial participation.[At 6‐months, feasibility will be reviewed and if the above criteria are not met, the trial will be modified ] SECONDARY OUTCOME: Attainment of SMART goal for dementia risk reduction behaviour change as determined in goal‐setting interview with HBA psychologist[Post 10‐week intervention] Change in alcohol consumption assessed by AUDIT‐C.[Post 10‐week intervention] Change in auditory‐verbal memory assessed by Rey Auditory Verbal Learning Test[Post 10‐week intervention] Change in depressive symptoms assessed by Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH‐D).[Post 10‐week intervention] Change in global cognitive function assessed by Montreal Cognitive Assessment (MoCA). ; ; INCLUSION CRITERIA: 1. Individuals aged 60‐75 years who meet the Winblad criteria for mild cognitive impairment (MCI) as tested at the HBA clinic; 2. Able to engage in the study over a period of three months including attendance at the Thompson Institute on a weekly basis over a 12‐week period. 3. Willingness to undergo cognitive testing, actigraphy, complete self‐report questionnaires, and an MRI scan (pass MRI safety checklist) at baseline and post‐intervention. ; [Post 10‐week intervention] Change in inhibitory control performance assessed by D‐KEFS Colour –Word Interference Test. [Post 10‐week intervention] Change in level of social support assessed by Duke Social Support Index.[Post 10‐week intervention] Change in memory assessed by WMS‐IV Logical Memory I and II (Wechsler Memory Scale, IV). [Post 10‐week intervention] Change in memory strategy usage assessed by Multifactorial Memory Questionnaire.[Post 10‐week intervention] Change in perceived cognitive difficulties assessed by British Columbia Cognitive Complaints Inventory (BC‐CCI).[Post 10‐week intervention] Change in regional brain volumes as assessed by structural MRI scan[Post 10‐week intervention] Change in sleep duration as determined by actigraphy monitoring and 7‐day sleep diary completion[Post 10‐week intervention] Change in sleep onset latency defined by actigraphy and 7‐day sleep diary[Post 10‐week intervention] Change in sleep quality as determined by actigraphy monitoring and 7‐day sleep diary completion[Post 10‐week intervention] Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).[Post 10‐week intervention] Change in subjective memory failures assessed by Everyday Memory Questionnaire (EMQ).[Post 10‐week intervention] Change in subjective well‐being assessed by WHO‐5 Well‐being Index.[Post 10‐week intervention.] Change in symptoms of anxiety assessed by Geriatric Anxiety Inventory (GAI). [Post 10‐week intervention] Change in symptoms of anxiety assessed by State/Trait Anxiety Inventory.[Post 10‐week intervention] Change in symptoms of depression assessed by Geriatric Depression Scale (GDS‐15). ; [Post 10‐week intervention] Change in time spent engaging in cognitively stimulating activities assessed by Cognitively‐stimulating activities – revised.[Post 10‐week intervention] Change in verbal fluency assessed by Controlled Oral Word Association Test[Post 10‐week intervention] Change in visual attention and task switching assessed using the Trail making test. ; [Post 10‐week intervention] Change in visuospatial memory assessed by Rey Complex Figure Test[Post 10‐week intervention] Change in word retrieval assessed by Boston Naming Test.[Post 10‐week intervention] Change in working memory capacity assessed by Digit Span subtest (Wechsler Adult Intelligence Scale, IV)[Post 10‐week intervention] Changed resting state functional network activation as assessed by resting state functional MRI scan[Post 10‐week intervention] HBA Dementia Risk Profile Report[Post 10‐week intervention] 4. Access to and ability to use mobile phone for text message alerts.
Epistemonikos ID: b24cdfe4359263c466d83e717251737e460dc40a
First added on: Aug 24, 2024