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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve life satisfaction and health outcomes for people with mild cognitive impairment (MCI) and their caregivers. It tests a program called Daily Engagement in Meaningful Activities (DEMA), which helps participants identify enjoyable activities, solve problems, and learn about MCI management. Participants are divided into two groups: one receives the DEMA program, while the other receives educational support (Information Support, IS). Those with MCI who have noticed memory issues and can manage daily tasks, along with their caregivers, are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance daily living for those with MCI.

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 prior data suggests that the DEMA intervention is safe for patients with mild cognitive impairment?

Research has shown that the Daily Engagement in Meaningful Activities (DEMA) program has been tested for participant engagement. In these studies, individuals with mild memory problems and their caregivers participated in DEMA sessions. The goal was to ensure the activities were both meaningful and helpful.

No serious issues have been reported with the DEMA program itself. Participants engaged in the activities without major problems. A nurse leads the program, which involves identifying meaningful activities and collaboratively solving problems. This approach appears well-tolerated, allowing participants to engage without negative effects.

While specific data on adverse events is not available, the absence of reports suggests that DEMA is a safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Daily Engagement Meaningful Activity (DEMA) intervention for mild cognitive impairment because it offers a fresh approach to managing the condition through personalized, meaningful activities. Unlike typical treatments that might focus on medication or generalized cognitive exercises, DEMA emphasizes individual autonomy and problem-solving therapy, allowing patients to engage in activities that are personally significant and supported by family. This unique approach not only aims to enhance cognitive function but also improves quality of life by empowering patients to take an active role in their treatment. Additionally, the use of tailored sessions both face-to-face and via phone provides flexibility and accessibility for participants.

What evidence suggests that the DEMA intervention is effective for mild cognitive impairment?

Research has shown that the Daily Engagement Meaningful Activity (DEMA) program, a treatment arm in this trial, can enhance life satisfaction for individuals with mild cognitive impairment (MCI) and their caregivers. Studies have found that DEMA, which engages patients in meaningful activities, improves health outcomes. Participants collaborate with a nurse to select enjoyable activities, address challenges, and establish routines. Early results indicate that this approach not only boosts mood but also helps manage cognitive symptoms. By focusing on activities important to patients, DEMA supports both mental engagement and emotional well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Yvonne Y Lu, PhD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11966638/

Promoting Daily Engagement in Meaningful Activity (DEMA ... A randomized controlled trial to test the efficacy of the Daily Engagement in Meaningful Activity (DEMA) intervention for PwCI and their CGs.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04515875?cond=Cognitive%20Dysfunction&viewType=Table&term=INTRINSIC%20FACTOR&rank=8

PRIMA Intervention for Adults With Mild Cognitive ... The investigators developed and tested the Daily Engagement in Meaningful Activities (DEMA) intervention to improve life satisfaction and health outcomes ...

3. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/items/81ebe3a7-ea7f-4419-9191-3b70925b07d0

Promoting Daily Engagement in Meaningful Activity (DEMA ... A randomized controlled trial to test the efficacy of the Daily Engagement in Meaningful Activity (DEMA) intervention for PwCI and their CGs.

4. clinicaltrial.be clinicaltrial.be/en/details/53379?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

PRIMA Intervention for Adults With Mild Cognitive Impairm... The investigators developed and tested the Daily Engagement in Meaningful Activities (DEMA) intervention to improve life satisfaction and health ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3220889/

Content Validity and Acceptability of the Daily ... Content Validity and Acceptability of the Daily Enhancement of Meaningful Activity Program Intervention for Mild Cognitive Impairment Patient-Spouse Dyads.

6. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstreams/26d9ed16-6414-4606-abeb-07472359fb42/download

experience and participation implications of daily (d) persons with mild cognitive impairment (PwMCI) and caregivers' experiences. 66,67. The DEMA is intended to facilitate goal identification and achievement, ...

7. researchgate.net researchgate.net/publication/297592345_Feasibility_and_Effect_Sizes_of_the_Revised_Daily_Engagement_of_Meaningful_Activities_Intervention_for_Individuals_With_Mild_Cognitive_Impairment_and_Their_Caregivers

(PDF) Feasibility and Effect Sizes of the Revised Daily ... A nurse-led intervention, Daily Engagement of Meaningful Activities (DEMA), was evaluated for feasibility and effect sizes in a two-group ...