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Can a simple program boost life satisfaction for those with mild cognitive impairment?

NCT ID NCT04515875

Symptom relief Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests a behavioral program called Daily Engagement in Meaningful Activities (DEMA) for people with mild cognitive impairment and their family caregivers. Over seven sessions, a nurse helps the pair identify meaningful activities, solve problems that get in the way, and build routines. The goal is to improve life satisfaction and emotional health for both the person with MCI and their caregiver.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a behavioral program called Daily Engagement in Meaningful Activities (DEMA) that uses problem-solving therapy and self-management tools
What this could lead to
If successful, this program could offer a practical, non-drug way to improve life satisfaction and emotional well-being for people with mild cognitive impairment and their caregivers.
What could go wrong
This is a relatively small, early-stage trial testing a behavioral intervention, so results may not apply broadly. The program requires active participation and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

420 people

The number who actually took part.

Started

Dec 2021

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: MCI Patient * age greater than 59 years old * able to speak and read English * access to telephone * have both self or informant reported cognitive complaints * MoCA score = 15 to 25 * 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); Inclusion Criteria: Family caregivers: * self-identify as care partner (i.e. spouse, family member or friend) * aged greater than or equal to 18 years * have primary responsibility for providing care to an MCI patient, along with monitoring safety and providing social support; * are able to speak and read English; * access to telephone * oriented to persons, places, and time (having a 6-item Screener score of 4 or above). Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild cognitive impairment

Contacts and locations

Locations

  • Indiana University Alzhemier Disease Research Center

    Indianapolis, Indiana, 46202, United States

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Other studies related to the condition(s) this trial covers.