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COMPLETED
NCT04515875
NA

PRIMA Intervention for Adults With Mild Cognitive Impairment and Their Caregivers

Sponsor: Indiana University

View on ClinicalTrials.gov

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 210 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2021-12-13

Completion Date

2025-07-20

Last Updated

2026-07-15

Healthy Volunteers

No

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. Each session consists: 1) MCI dyads are guided to use the principles of problem-solving therapy to review their personalized, self-selected meaningful activities and plan next steps to continue the activity, identify and establish a plan for additional activities; and 2) the intervener and dyad discuss one of the 6 topics in the Toolkit such as introducing of the intervention and meaningful activity concepts, understanding MCI, its treatments, management, resources, and planning for the future.

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 the opportunity to ask only questions related to the educational materials. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.

Locations (1)

Indiana University Alzhemier Disease Research Center

Indianapolis, Indiana, United States