Evaluation of an Intervention for Living With Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baycrest
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Kelly Murphy, Ph.D., C.Psych, Baycrest
ClinicalTrials.gov Identifier:
NCT02083237
First received: January 31, 2013
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
Behavioral: Behavioural Intervention Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Evaluation of a Behavioural Intervention for People Living With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Baycrest:

Primary Outcome Measures:
  • Change from baseline in memory strategy knowledge and application [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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.

  • Change from baseline in functional memory skills [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from baseline in family member coping skills. [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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).

  • Change in mood status from baseline [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Positive change in healthy lifestyle practices in persons affected by Mild Cognitive Impairment [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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.

  • Improved instrumental activities of daily living - change from baseline [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Behavioural Intervention Program
People with MCI and their close family member (80% spouses) participate jointly in the first hour, which provides education about MCI, lifestyle influences on cognitive health, and community resources. During the second hour, family members participate in a separate psychosocial group intervention, while the individuals with MCI participate in memory training. The first 6 of the 8 sessions occur weekly, the 7th occurs as a 1-month follow-up session and the 8th as a 3-month follow-up session. These follow-up sessions provide support to sustain positive outcomes and provide further assistance with resolving continued challenges.
Behavioral: Behavioural Intervention Program
People with MCI and their close family member (80% spouses) participate jointly in the first hour, which provides education about MCI, lifestyle influences on cognitive health, and community resources. During the second hour, family members participate in a separate psychosocial group intervention, while the individuals with MCI participate in memory training. The first 6 of the 8 sessions occur weekly, the 7th occurs as a 1-month follow-up session and the 8th as a 3-month follow-up session. These follow-up sessions provide support to sustain positive outcomes and provide further assistance with resolving continued challenges.
No Intervention: Waitlist Control
Due to the heavy demand for this clinical program, there is a naturally-occurring waitlist of approximately 3 months. Control participants are assessed during this period.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083237

Contacts
Contact: Rita Vitorino, H.B.Sc. (416) 785-2500 ext 2422 rvitorino@baycrest.org
Contact: Kelly J. Murphy, PhD, CPsych (416) 785-2500 ext 3184 kmurphy@baycrest.org

Locations
Canada, Ontario
Baycrest Recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Kelly J Murphy, PhD, CPsych    (416) 785-2500 ext 3184    kmurphy@baycrest.org   
Principal Investigator: Kelly J. Murphy, PhD, CPsych         
Sponsors and Collaborators
Baycrest
University of Manitoba
Investigators
Principal Investigator: Kelly J. Murphy, PhD, CPsych Baycrest
  More Information

Additional Information:
Publications:

Responsible Party: Kelly Murphy, Ph.D., C.Psych, Clinical Neuropsychologist, Baycrest
ClinicalTrials.gov Identifier: NCT02083237     History of Changes
Other Study ID Numbers: REB0650
Study First Received: January 31, 2013
Last Updated: March 7, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Baycrest:
mild cognitive impairment
memory training
healthy lifestyle
psychosocial support

Additional relevant MeSH terms:
Mild Cognitive Impairment
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014