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Completed

NCT Number: NCT01843283

Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

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.

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Key information

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

MCI patients:

  • are aged 60 years or older,
  • speak English,
  • have both caregiver-reported, clinically significant decline in cognition and clinician-detected or research based cognitive impairment on the standardized health exam
  • have at least one cognitive assessment score below the 7th percentile
  • 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:

  • are adults ≥ 21 years of age;
  • have primary responsibility for providing unpaid care to an MCI relative, along with monitoring safety and providing social support
  • are able to read and speak English
  • 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:

  • the MCI patient or family caregiver has a diagnosed bipolar disorder or untreated schizophrenia;
  • the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE < 4)

Treatment and study plan

Daily Enhancement Meaningful Activity (DEMA)

Behavioral

Information Support (IS)

Behavioral

Primary outcomes

  1. Patient_Depression symptoms: Patient Health Questionnaire Depression Scale (PHQ-9)

    Time frame: Change in depression from baseline to immediately (two-week)- and 3 months post-intervention

Secondary outcomes

  1. Patient_satisfaction with communication: The subscale of Communication and Affective Responsiveness

    Time frame: Change in satisfaction with communication from baseline to immediately (two-week)- and 3 months post-intervention

  2. Patient_Physical Function: Alzheimer disease cooperative study activities of daily living inventory.

    Time frame: Change in physical function from baseline to immediately (two-week)- and 3 months post-intervention

  3. Patient_Life satisfaction : Life Satisfaction Index for the Third Age-Short Form

    Time frame: Change in life satisfaction from baseline to immediately (two-week)- and 3 months post-intervention

  4. Patient_Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale

    Time frame: It will be collected at 3 months post-program evaluation

  5. Patient_ Meaningful activities engagement performance and satisfaction: Canadian Occupational Performance Measure & weekly log

    Time frame: Change in meaningful activities engagement performance and satisfactionfrom baseline to immediately (two-weeks)- and 3 months post-intervention

  6. Patient_Sense of confidence: Confidence Scale

    Time frame: Change in sense of confidence from baseline to immediately (two-week)- and 3 months- post program

  7. Caregiver_Depressive Symptoms: PHQ-9

    Time frame: Change in depressive symptoms from baseline to immediately (two-week)- and 3 months post-program evaluation

  8. Caregiver_ Caregiver life changes: Caregiving Outcomes Scale

    Time frame: Change in caregivign outcomes from baseline to immediately (two-week)- and 3 months post-post program

  9. Caregiver_- Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale

    Time frame: It will be assessed at 3 months post-program evaluation

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Apr 30, 2013
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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