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Meaningful Activity Intervention for Persons With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Daily Enhancement Meaningful Activity (DEMA)
Information Support (IS)
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Family Caregivers, Intervention studies

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Indiana University School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daily Enhancement Meaningful Activity (DEMA)

Information Support (IS)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient_satisfaction with communication: The subscale of Communication and Affective Responsiveness
Patient_Physical Function: Alzheimer disease cooperative study activities of daily living inventory.
Patient_Life satisfaction : Life Satisfaction Index for the Third Age-Short Form
Patient_Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale
Patient_ Meaningful activities engagement performance and satisfaction: Canadian Occupational Performance Measure & weekly log
Patient_Sense of confidence: Confidence Scale
Caregiver_Depressive Symptoms: PHQ-9
Caregiver_ Caregiver life changes: Caregiving Outcomes Scale
Caregiver_- Satisfaction with program: Satisfaction with Meaningful Activity Program Scale is adapted from the Caregiver Satisfaction Scale

Full Information

First Posted
April 26, 2013
Last Updated
October 24, 2016
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01843283
Brief Title
Meaningful Activity Intervention for Persons With Mild Cognitive Impairment
Official Title
Meaningful Activity Intervention for Persons With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Family Caregivers, Intervention studies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily Enhancement Meaningful Activity (DEMA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Information Support (IS)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Daily Enhancement Meaningful Activity (DEMA)
Intervention Type
Behavioral
Intervention Name(s)
Information Support (IS)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Patient_Sense of confidence: Confidence Scale
Time Frame
Change in sense of confidence from baseline to immediately (two-week)- and 3 months- post program
Title
Caregiver_Depressive Symptoms: PHQ-9
Time Frame
Change in depressive symptoms from baseline to immediately (two-week)- and 3 months post-program evaluation
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Lu, PhD
Organizational Affiliation
IU School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Nursing
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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