DEMA Intervention for Mild Cognitive Impairment
(PRIMA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byYvonne Y Lu, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Indiana University

Trial Summary

What is the purpose of this trial?This trial tests the Daily Engagement in Meaningful Activities (DEMA) intervention, which helps older adults with mild cognitive impairment and their caregivers engage in meaningful activities. The goal is to improve their life satisfaction and reduce depressive symptoms and anxiety. Participants work with a nurse to identify activities, solve problems, and learn about MCI. The DEMA intervention has been previously evaluated for its acceptability, feasibility, and potential benefits in helping couples facing mild cognitive impairment (MCI) remain engaged in meaningful activities.

Eligibility Criteria

This trial is for pairs of adults over 59 with mild cognitive impairment (MCI) and their caregivers. Participants need to speak English, be oriented in time and space, have a phone, and not require help with daily tasks. Caregivers must be adults providing unpaid care without severe cognitive issues themselves.

Inclusion Criteria

I am over 18, care for someone with MCI, speak English, and am mentally oriented.

I am over 59, speak English, have memory concerns, a MoCA score of 15-25, and can do daily tasks without help.

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.

Exclusion Criteria

I do not have severe depression, advanced cancer treatment, dialysis, severe hearing loss without aids, lack of phone access, or a caregiver with significant cognitive issues.

Participant Groups

The study tests the DEMA program against an information support group. DEMA aims to improve life satisfaction by helping patients/caregivers identify meaningful activities and learn about MCI through sessions with a nurse.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Daily Engagement Meaningful Activity (DEMA)Experimental Treatment1 Intervention

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.

Group II: Information Support (IS)Placebo Group1 Intervention

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.