Meaningful Activity Intervention for Persons With Mild Cognitive Impairment



Status:Recruiting
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 95
Updated:3/16/2015
Start Date:July 2012
Contact:Yvonne Lu, PhD
Email:yuelu@iupui.edu
Phone:317-278-2042

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The purpose of this pilot study is to evaluate the feasibility of and satisfaction with the
revised DEMA and to estimate effect sizes for DEMA through incorporation of a comparison
group. Specific aims are as follows:

Aim 1: Evaluate feasibility of the study for MCI patient/caregivers. Aim 2: Estimate effect
sizes for DEMA on MCI patient and caregiver outcomes. Aim 3: Evaluate MCI patients and
family caregivers' satisfaction with and perceptions of DEMA or IS.

Mild cognitive impairment (MCI) affects as many as 20% of older adults who are at a greater
risk of developing Alzheimer's disease (AD). MCI involves functional decline that may
include decrements in engagement in meaningful activities and one's own sense of
confidence/mastery, and it is associated with depressive symptoms, poor satisfaction with
family communication, and declining physical function. Existing interventions for MCI
patients and caregivers often focus on a single problem, such as memory or physical activity
and there are no available multi-faceted supportive care interventions to meet the needs of
the MCI patients and their caregivers in order to prevent premature disengagement and risk
for depressive symptoms. The Daily Enhancement of Meaningful Activity (DEMA) intervention
uses a family dyadic, strengths-based, and positive health approach that builds on existing
dyadic skills and values to accomplish meaningful activity engagement to address the
priority needs for efficacious interventions to prevent premature disengagement and
depressive symptoms in MCI patients. The DEMA builds on the investigators' previous
descriptive work and gerontology theory, the model human occupation, and components of the
Problem-Solving Therapy. The investigators' preliminary findings showed that the
intervention and measures were acceptable, and suggestions were solicited from the
participants for improving delivery. The purpose of this pilot study is to 1) evaluate the
feasibility and satisfaction of the revised DEMA intervention; and 2) estimate effect sizes
for the intervention through the incorporation of a comparison group. The MCI-caregiver
dyads (n = 36 dyads) will be randomized to the DEMA or informational support groups; each
group will receive 6 bi-weekly sessions (2 face-to-face and 4-phone delivered) with a
trained intervener. The data from MCI patients and caregivers outcomes will be collected at
pre-intervention, immediately (two weeks) post-intervention, and 3 months post-program
evaluation. Descriptive statistics analysis will be used for satisfaction with and
perception of the DEMA or informational support groups and general linear mixed models will
be used to estimate the effect sizes of the intervention on the proximal and distal
outcomes. Findings will inform the design of a subsequent R01 to: 1) test the efficacy of
DEMA for MCI patient-caregiver dyads in a longitudinal randomized clinical trial; and 2)
explore the costs/benefits of implementation. If it is found to be efficacious, DEMA has the
potential to slow the rate of disability progression from MCI to AD and improve quality of
life outcomes for patients and caregivers.

Inclusion Criteria:

MCI patients:

1. are aged 60 years or older,

2. speak English,

3. have both caregiver-reported, clinically significant decline in cognition and
clinician-detected or research based cognitive impairment on the standardized health
exam

4. have at least one cognitive assessment score below the 7th percentile

5. have a normal range in performance of daily living tasks based on informant interview
information indicating that impairment does not rise to the level of dementia.

Family caregivers:

1. are adults ≥ 21 years of age;

2. have primary responsibility for providing unpaid care to an MCI relative, along with
monitoring safety and providing social support

3. are able to read and speak English

4. are oriented to persons, places, and time [having a 6-item Mini-Mental State
Examination (MMSE) score of 4 or above]

Exclusion Criteria:

MCI patients and family caregivers will be excluded if:

1. the MCI patient or family caregiver has a diagnosed bipolar disorder or untreated
schizophrenia;

2. the family caregiver has significant cognitive impairment that may hinder
participation (6-item MMSE < 4)
We found this trial at
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Indianapolis, Indiana 46202
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Indianapolis, IN
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