Meaningful Activity Intervention for Persons With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Daily Enhancement Meaningful Activity (DEMA); Information Support (IS)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Mild Cognitive Impairment; Family Caregivers; Intervention studies