Clinical Trial: Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

Brief 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 Summary: 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,
Sponsor: Indiana University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Patient_Sense of confidence: Confidence Scale [ Time Frame: Change in sense of confidence from baseline to immediately (two-week)- and 3 months- post program ]
  • Caregiver_Depressive Symptoms: PHQ-9 [ Time Frame: Change in depressive symptoms from baseline to immediately (two-week)- and 3 months post-program evaluation ]
  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: April 26, 2013
Date Started: July 2012
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016