DEMA Intervention for Mild Cognitive Impairment

(PRIMA Trial)

Overseen By Pei-Shiun E Chang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Severe depression, Advanced cancer, Dialysis, others

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

420 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on activities and support rather than medication changes.

What data supports the effectiveness of the DEMA treatment for mild cognitive impairment?

The DEMA treatment shows promise in helping people with mild cognitive impairment stay engaged in meaningful activities and maintain health-related outcomes, with participants reporting high satisfaction and positive trends in activity performance. However, more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

How is the DEMA treatment different from other treatments for mild cognitive impairment?

The DEMA treatment is unique because it focuses on keeping people with mild cognitive impairment engaged in meaningful daily activities, which helps them and their caregivers adjust to cognitive changes. Unlike drug treatments, DEMA is a non-drug approach that aims to improve quality of life and maintain physical and mental health through personalized activity engagement. ^{1 2 3 4 6}

Research Team

Yvonne Y Lu, PhD

Principal Investigator

Indiana University School of Medicine

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DEMA intervention over 7 sessions, including 1 face-to-face session and 6 bi-weekly telephone sessions.

12 weeks

1 visit (in-person), 6 visits (virtual)

Follow-up

Participants are monitored for changes in life satisfaction, activity performance, and emotional function.

6 months

Treatment Details

Interventions

• Daily Engagement Meaningful Activity (DEMA)
• Information Support (IS)

Trial Overview 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.

Participant Groups

Group I: Daily Engagement Meaningful Activity (DEMA) Experimental Treatment 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

The PrAISED intervention, which involved up to 50 therapy sessions focusing on exercise and functional activities for adults with early dementia or mild cognitive impairment, did not show significant improvements in daily living activities, physical activity, or quality of life compared to usual care after 12 months.

Although the intervention group experienced fewer falls (79 falls) compared to the control group (200 falls), the difference was not statistically significant, indicating that the exercise program did not effectively reduce fall risk or improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. Harwood, RH., Goldberg, SE., Brand, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Satisfaction With a Family-Focused Intervention for Mild Cognitive Impairment Dyads. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Pilot testing a couples-focused intervention for mild cognitive impairment. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Change in Depression, Confidence, and Physical Function Among Older Adults With Mild Cognitive Impairment. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

State of the science on mild cognitive impairment (MCI). [2020]

5. England pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Impaired instrumental activities of daily living affect conversion from mild cognitive impairment to dementia: the Osaki-Tajiri Project. [2016]