Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Mild Cognitive Impairment
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study conceptual framework is based on: 1) pilot work, 2) the Canadian Model of Occupational Performance that describes how individuals are motivated, adjust to psychosocial context and cognitive decline, and choose to participate in essential and meaningful daily activities; 3) problem-solving therapy principles. These frameworks, commonly applied to health problems in older populations, provide a systematic structure to improve task initiation and completion in adults with depression or executive dysfunction.Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Following consent, the project manager will arrange a time convenient for patient-caregiver dyads to separately complete the baseline (T1) measures by phone. A data collector, blinded to randomization status, will administer all measures at all time points via phone interviews in a quiet, private setting and be available for questions following data collection. Immediately following completion of the T1 measures; and enter patient scores on the PHQ-9 depression scale directly to the database. A web-based computer-generated stratified randomization scheme will be used to assign the patient-caregiver dyads to DEMA or the information support group in 1:1 ratio using a block-randomized approach stratified on a depression score PHQ-9 ? 4 vs. PHQ-9 ? 5 or higher will be used to determine the randomization scheme. The Project Manager will immediately schedule Session 1. Only the statistician, PI, project manager, and the intervener will know the patient-caregiver dyad's randomization status.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

Description

Approximately 20% of Americans over 65 have mild cognitive impairment (MCI), defined as experiencing more memory problems than normally expected with aging, but no other symptoms of dementia such as impaired judgment or reasoning. Persons with MCI (patients) are at great risk for developing dementia...

Approximately 20% of Americans over 65 have mild cognitive impairment (MCI), defined as experiencing more memory problems than normally expected with aging, but no other symptoms of dementia such as impaired judgment or reasoning. Persons with MCI (patients) are at great risk for developing dementia (10-33% per year). Memory problem (poor executive function) diminish the patient's confidence and ability to perform meaningful and/or important activities (e.g. socialization, medication management). Deteriorating life satisfaction in patients and care partners (caregivers) is a prevalent problem due to diminished meaningful activity engagement which occurs as a result of patient frustration and embarrassment, lack of self-efficacy (confidence), and diminishing activity performance. As a result, patients experience additional negative health outcomes: 38% report depressive symptoms and anxiety. Caregivers often lack confidence to manage their own and the patient's daily challenges and meaningful activity engagement, leading to high caregiver burden, depressive symptoms, and anxiety. As a dyad, both patients and caregivers report diminished satisfaction within their communication and relationship due to disagreement about the patient's functional ability to effectively and safely perform meaningful activities. Emerging evidence indicates regular engagement in social, physical or cognitive activities can improve life satisfaction, activity performance, depressive symptoms, anxiety, and dyad communication; health outcomes are even better when the activities are self-selected and meaningful. To promote patients' and caregivers' life satisfaction and health outcomes, interventions to maximize patients' capacity for full engagement in meaningful activities are essential; yet, there is a marked absence of such empirically validated interventions. The investigators developed and tested the Daily Engagement in Meaningful Activities (DEMA) intervention to improve life satisfaction and health outcomes for patients and caregivers. DEMA is a positive health focused, theoretically grounded, tailored, family-centered, multi-faceted intervention. Over 7 session, dyads work with a nurse to 1) identify meaningful activities, assess capacity, problem-solve barriers, and establish routines for engagement and 2) learn more about MCI by working through six Self-Management Toolkit topics (e.g., benefits of meaningful activity; planning the future). The investigators' purpose is to evaluate the efficacy of DEMA in a two-group randomized controlled trial with 200 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group). Aim 1 (Primary Objective): Test DEMA's efficacy for improving life satisfaction in patients and their caregivers over time. Aim 2 (Secondary Objective): Over time, evaluate DEMA's efficacy for patient and caregiver to: increase patient activity performance and diminish depressive symptoms and anxiety. Hypothesis 2.1: Compared to the IS group, patients receiving DEMA will have improved activity performance and decreased depressive symptoms and anxiety. decrease caregivers burden, depressive symptoms, and anxiety . Hypothesis 2.2: Compared to the IS group, caregivers receiving DEMA will have decreased burden, depressive symptoms, and anxiety. Aim 3: Explore improvement in health outcomes over time in the sub-sample of patients with depressive symptoms using the (PHQ)-9 ? 5 at baseline) and explore the burden on caregivers when patients have PHQ-9 is >5. Compared to the non-depressed participants: Hypothesis 3.1. Patients with depressive symptoms (scores > 5 on PHQ-9 measured at baseline) will have improved activity performance. Hypothesis 3.2 Caregivers of patients with depressed symptoms (scores > 5 on PHQ-9 measured at baseline) will report reduced burden. Hypotheses 3.3. Patients with depressive symptoms (scores > 5 on PHQ-9 measured at baseline) and their caregivers randomized to DEMA will report improved: confidence to manage daily challenges, communication satisfaction, life satisfaction, relationship satisfaction, decreased depressive symptoms and anxiety.

Tracking Information

NCT #
NCT04515875
Collaborators
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Yvonne Y Lu, PhD Indiana University School of Medicine