Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

Last updated: October 24, 2016
Sponsor: Indiana University
Overall Status: Completed

Phase

1

Condition

Dementia

Memory Loss

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT01843283
1R21NR013755-01
  • Ages 21-95
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: MCI patients:

  1. are aged 60 years or older,

  2. speak English,

  3. have both caregiver-reported, clinically significant decline in cognition andclinician-detected or research based cognitive impairment on the standardized healthexam

  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 interviewinformation indicating that impairment does not rise to the level of dementia. Family caregivers:

  6. are adults ≥ 21 years of age;

  7. have primary responsibility for providing unpaid care to an MCI relative, along withmonitoring safety and providing social support

  8. are able to read and speak English

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

Exclusion

Exclusion Criteria: MCI patients and family caregivers will be excluded if:

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

  2. the family caregiver has significant cognitive impairment that may hinderparticipation (6-item MMSE < 4)

Study Design

Total Participants: 80
Study Start date:
July 01, 2012
Estimated Completion Date:
May 31, 2016

Study 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.

Connect with a study center

  • Indiana University School of Nursing

    Indianapolis, Indiana 46202
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.