Promoting Reengagement in Daily Meaningful Activity (PRIMA) Intervention for Adults With Mild Cognitive Impairment and Their Caregivers

Plain English Summary

PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers is a Not Applicable clinical trial sponsored by Indiana University studying Mild Cognitive Impairment. This study tests a program called DEMA, designed to help individuals with mild cognitive impairment (MCI) and their family caregivers find and engage in meaningful activities. It is for adults over 59 with mild memory loss (MCI) and their chosen family caregiver (spouse, friend, or relative). Participants will attend 7 sessions with a nurse, including one in-person meeting and six phone calls, to identify activities, learn about MCI, and develop strategies for engagement. The alternative is an 'information support' group that receives educational materials about Alzheimer's disease and study procedures. The trial aims to enroll 420 participants.

Official 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).

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are over 59, can read and speak English, have noticed memory changes, have a specific score on a memory test (MoCA 15-25), and can still manage daily tasks. Your caregiver must also be over 18, able to read and speak English, identify as your care partner, and be able to participate. You cannot join if you have severe untreated depression, are receiving advanced cancer treatment or hospice care, are on dialysis, have severe hearing loss without aids, or lack phone access. This trial is studying Mild Cognitive Impairment, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how satisfied patients feel with their lives, assessing if the program helps them feel happier and more fulfilled over time. The specific primary outcome measures are: Life satisfaction (Change from Baseline Life Satisfaction at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a gap in support for individuals with mild cognitive impairment by offering a structured program to enhance their quality of life and that of their caregivers through engagement i This research targets Mild Cognitive Impairment, where improved treatment options are needed.

Investor Insight

This trial focuses on a growing population with Mild Cognitive Impairment, a condition that precedes dementia, indicating a significant market for supportive interventions and a potential for early-st

Is This Trial Right for Me?

Ask your doctor if this program is right for you and how it might help with your memory concerns. Be prepared to discuss activities you enjoy and challenges you face in doing them. Participation involves regular sessions with a nurse, both in-person and by phone, to work on a personalized plan. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 420 participants

Interventions

• BEHAVIORAL: Daily Engagement Meaningful Activity (DEMA) — This group will receive 7 individualized sessions, 1 face-to-face session at week 1 and via 6 bi weekly telephone sessions delivered by a trained intervener. DEMA will use the principles of problem-solving therapy and consistent with the overall goals of this intervention; and will provide autonomy support, 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. E
• BEHAVIORAL: Information Support (IS) — This group will attend 1 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer disease educational brochure from the Alzheimer's Association (AA). The face-to-face sessions will take place at the IADC Clinical Core clinic, Indiana University Center of Excellence of Women's Health clinic, or Indiana School of Nursing conference room that based on patient-caregiver dyad's preference. Then they will receive 6 bi weekly follow-up phone calls and have

Primary Outcomes

• Life satisfaction (Change from Baseline Life Satisfaction at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)

Secondary Outcomes

• Patient Health Questionnaire-9 Items (PHQ-9) (Change from Baseline PHQ-9 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
• The General Anxiety Disorder 7-item (GAD-7) (Change from Baseline GAD-7 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
• Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale] (Change from Baseline ADCS-MCI-ADL at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
• Relationship Assessment Scale (RAS) (Change from Baseline RAS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
• Caregiving Outcomes Scale (COS) (Change from Baseline COS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)

Full 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).

Trial Locations

• Indiana University Alzhemier Disease Research Center, Indianapolis, Indiana, United States

Frequently Asked Questions

Related Conditions

• Mild Cognitive Impairment
• Dementia
• Alzheimer's Disease
• Aging
• Memory Loss
• Caregiver Support
• Quality of Life
• Behavioral Interventions
• Geriatrics
• Neurology

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