Mild Cognitive Impairment Clinical Trial
Official title:
Evaluation of a Behavioural Intervention for People Living With Mild Cognitive Impairment
Mild cognitive impairment (MCI) is a significant risk factor for dementia. Persons with MCI experience cognitive changes, most typically affecting memory; that are greater than those experienced in "normal" aging. However, these cognitive changes in MCI, unlike in dementia, are not significant enough to markedly interfere with functional independence. In addition to cognitive change, some people with MCI also experience elevated symptoms of depression and anxiety, which adds to their risk of developing dementia. Close family are also impacted by their relative's MCI and show mild physical (e.g., increased incidence of systemic health problems such as high blood pressure) and mental health declines (e.g., elevated symptoms associated with depression and anxiety) that are similar, though not as severe, to those experienced by caregivers of a relative with dementia. Programs aimed at behavioural intervention have real potential to reduce and/or prevent negative health outcomes associated with MCI and future dementia by promoting positive behaviour changes. We wish to scientifically establish the utility of a behavioural intervention aimed at addressing the needs of both the person with MCI and their close family member, with the ultimate goal of lowering current and future susceptibility to mental health declines and chronic disease in people living with MCI. We have an 8 session (16 hour) program, where participants with MCI and their close relative are together for the first half of each session, which is devoted primarily to enabling positive lifestyle choice. In the second hour the group splits up, with MCI clients engaging in memory training while their close family member participates in a psychosocial intervention.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - diagnosis of mild cognitive impairment - a supportive family or friend of the person with mild cognitive impairment Exclusion Criteria: - psychiatric illness - dementia - substance abuse |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Baycrest | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Baycrest | University of Manitoba |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Positive change in healthy lifestyle practices in persons affected by Mild Cognitive Impairment | The Health-Promoting Lifestyle Profile Questionnaire (Walker et al., 1987) will be used to assesses self-reported frequency of engaging in a broad range of health behaviours related to healthy diet, physical exercise, social and intellectual engagement, maintenance of positive mood, and stress reduction. This scale has been demonstrated to have good content and construct validity and good reliability in a variety of populations (e.g., Kuster et al., 1993; Cao et al., 2012). This questionnaire will be used to establish positive change in healthy lifestyle practices in persons affected by MCI (both the individual with MCI and their close family member) related to eating habits and level of engagement in physical, cognitive and social leisure activities. These lifestyle practices have been independently associated with reduced risk of dementia and other chronic diseases such as diabetes and heart disease, and mental health problems such as depression and anxiety. | Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). | No |
Other | Improved instrumental activities of daily living - change from baseline | The MCI version of the Activity of Daily Living Inventory (ADCS; Galasko, 1997) is a 24-item measure involving family ratings of their MCI relative's level of independence in performing a variety of complex activities of daily living (e.g., getting around town on their own). Research shows the psychometric properties of this measure are valid and reliable (Galasko, 2005). | Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). | No |
Primary | Change from baseline in memory strategy knowledge and application | Improved memory strategy knowledge and application will be established with the following measures: A) The Strategy subscale of the Multifactorial Metamemory Questionnaire (Troyer and Rich, 2002) which measures self-reported use of 19 memory aids and strategies (e.g., writing on a calendar, repeating information). Respondents indicate, on a 5-point scale, the frequency with which they used each strategy over the past two weeks; and B) Memory Situations (Troyer, 2001) assesses memory strategy knowledge. Respondents generate memory strategies to solve typical everyday memory situations (e.g., learning a new name). Responses are scored based on how effective, specific, and self-reliant they are for a maximum score of 12 points. | Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). | No |
Primary | Change from baseline in functional memory skills | 1] Memory Assessment Clinics Rating Scale (Crook & Larrabee, 1990) measures self and other perceptions of the MCI participant's memory ability and frequency of memory mistakes in everyday memory situations. The scale has reliable psychometric properties (Crook & Larrabee, 1992). 2] A modified version of the Canadian Occupational Performance Measure (COPM, Law et al., 1994) will help MCI participants self-identify memory problems, and, using 10 point Likert scales, rate their current performance and satisfaction level at managing the problems. This permits evaluation of the adaptive memory strategies acquired during the program. The scale has established psychometric properties. This approach has been shown to facilitate positive behaviour change in populations experiencing cognitive impairment (e.g., Dawson et al., 2009; Holliday et al., 2007; Handley et al., 2006). Family members will rate their MCI relative on the identified memory problem using the same scale. | Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). | No |
Secondary | Change from baseline in family member coping skills. | The Mastery Scale (Pearlin & Schooler, 1978) uses 7 items, rated on a 4-point scale, to assess the extent to which individuals feel personal control and mastery over important life outcomes. This reliable and valid scale is often used as a proxy measure of coping. The scale has solid psychometric properties (Majer et al., 2004; Marshall & Lang, 1990). | Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). | No |
Secondary | Change in mood status from baseline | 1] Depression Anxiety Stress Scales (DASS-21, Lovibond & Lovibond, 1995) assesses self-reported symptoms of anxiety, depression, and general stress and has solid psychometric properties for younger and older adults (Antony et al., 1998). 2] The Neuropsychiatric Inventory (NPI- Cummings et al., 1994). Developed for measuring neuropsychiatric symptoms in dementia, this is one of the most commonly used measures for such symptoms in MCI (14). It consists of 10 questions examining the presence and severity of a broad range of psychopathology (e.g., anxiety, irritability, apathy, euphoria) and is based on family report. It has been demonstrated to have excellent validity and reliability. | Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). | No |
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