Clinical trial NCT04515875: PRIMA Intervention for Adults with Mild Cognitive Impairment and Their Caregivers
Official title: Promoting Reengagement in Daily Meaningful Activity (PRIMA) Intervention for Adults with Mild Cognitive Impairment and Their Caregivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Quality of life
Family caregivers
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-08-17
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed 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 (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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

* Both the MCI patient and caregiver must consent to participate and have a phone at home or daily access to a telephone to be eligible for the study.

MCI patients will be eligible, if they:

* are aged \> 59 years old;
* able to speak and read English;
* have both self or informant reported cognitive complaints,
* have MoCA score = 15 to 25
* are in the normal range in performance of daily living tasks based on functional impairment absent: a check box of Functional Activities Questionnaire (FAQ) has no score ≥2);

Family caregivers (spouse, other family members or friends) will be eligible, if they

* self-identify as care partner
* are aged ≥ 18 years old,
* have primary responsibility for providing unpaid care to an MCI patient, along with monitoring safety and providing social support;
* are able to speak and read English;
* are oriented to persons, places, and time (having a 6-item Screener score of 4 or above).

Exclusion Criteria:

* MCI patients and family caregivers will be excluded, if the MCI patient or family caregiver dyads participants are:

  * a diagnosed untreated severe major depression, or receiving advanced cancer treatment or hospice care,
  * receiving dialysis,
  * severe hearing loss and no hearing aids,
  * have no access to a telephone
  * the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE \< 4).

Primary outcomes:
measure: Life satisfaction
timeFrame: Change from Baseline Life Satisfaction at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
Secondary outcomes:
measure: Patient Health Questionnaire-9 Items (PHQ-9)
timeFrame: Change from Baseline PHQ-9 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: The General Anxiety Disorder 7-item (GAD-7)
timeFrame: Change from Baseline GAD-7 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale]
timeFrame: Change from Baseline ADCS-MCI-ADL at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: Relationship Assessment Scale (RAS)
timeFrame: Change from Baseline RAS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: Caregiving Outcomes Scale (COS)
timeFrame: Change from Baseline COS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
Other outcomes:
measure: Confidence Scale
timeFrame: Change Baseline Confidence Scale at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: The subscale of Communication and Affective Responsiveness (CAR)
timeFrame: Change from Baseline subscale of CAR at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: Dementia Deficits Scale (DDS) (Patient vs. Caregiver Versions)
timeFrame: Change from Baseline DDS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: Change from Baseline COPM at Session 1(at Week 1), Session 2(at Week 2), Session 3 (at Week 4), Session 4 (at Week 6), Session 5 (at Week 8), Session 6 (at Week 10); Session 7 (at Week 12), 10 days post-, 3 months post-, and 6 months-post intervention
measure: The modified Credibility/Expectancy Questionnaire (CEQ)
timeFrame: 10 days post-intervention evaluation
measure: Six-item Screener [Completed by caregiver]
timeFrame: Pre-consent
measure: The Montreal Cognitive Assessment (MoCA) [Completed by Patient]
timeFrame: Pre-consent
measure: University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) [Completed by patients]
timeFrame: Pre-consent
measure: Demographic Profile and Comorbidity Condition
timeFrame: at Baseline, Pre-intervention Evaluation
measure: Patient's Anti-depression medication and Anxiety Medication (Medication type, dosage, and using time frame)
timeFrame: Changes from Baseline patient's Anti-depression and Anxiety Medication at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
measure: Functional Activities Questionnaire (FAQ) [for MCI patient]
timeFrame: Pre-consent
Locations:
city: Indianapolis
country: United States
facility: Indiana University Alzhemier Disease Research Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Yvonne Y Lu, PhD
role: PRINCIPAL_INVESTIGATOR
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