Trial record 2 of 139 for:    Open Studies | "Mild Cognitive Impairment"

Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01843283
First received: April 26, 2013
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Behavioral: Daily Enhancement Meaningful Activity (DEMA)
Behavioral: Information Support (IS)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Patient_Sense of confidence: Confidence Scale [ Time Frame: Change in sense of confidence from baseline to immediately (two-week)- and 3 months- post program ] [ Designated as safety issue: No ]
  • Caregiver_Depressive Symptoms: PHQ-9 [ Time Frame: Change in depressive symptoms from baseline to immediately (two-week)- and 3 months post-program evaluation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: July 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily Enhancement Meaningful Activity (DEMA)
The group member will receive Self-management Toolkit and 6 bi-weekly individualized sessions, 2 face-to-face and 4 via telephone delivered by a trained intervener. DEMA will provide autonomy support by helping patients to identify and prioritize activities, classify needs and goals, generalize manageable solutions, engage in self-selected activities under family support, and self-evaluate failure and success or renew problem-solving as needed.
Behavioral: Daily Enhancement Meaningful Activity (DEMA)
Active Comparator: Information Support (IS)
The IS group will receive 2 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer Association, educational brochure. Then they will receive 4 biweekly follow-up phone calls and have the opportunity to ask only questions related to the educational materials.
Behavioral: Information Support (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.

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843283

Contacts
Contact: Yvonne Lu, PhD 317-278-2042 yuelu@iupui.edu
Contact: Katie L Sundt, BA 317/274-7739 kalmcdan@iupui.edu

Locations
United States, Indiana
Indiana University School of Nursing Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Yvonne Lu, PhD    317-278-2042    yuelu@iupui.edu   
Contact: Katie L Sundt, BA    317-274-7739    kalmcdan@iupui.edu   
Principal Investigator: Yvonne Lu, PhD         
Sub-Investigator: Tamilyn Bakas, PhD         
Sub-Investigator: Joan E Haase, PhD         
Sub-Investigator: Mary G Austrom, PhD         
Sub-Investigator: Michael T Weaver, PhD         
Sponsors and Collaborators
Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01843283     History of Changes
Other Study ID Numbers: 1R21NR013755-01
Study First Received: April 26, 2013
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Mild Cognitive Impairment
Family Caregivers
Intervention studies

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014