Couple in Control Program for Mild Cognitive Impairment

Not currently recruiting at 1 trial location

Overseen By Kenneth Hepburn, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Minors, Pregnant, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with mild cognitive impairment (MCI) and their care partners improve communication and regain a sense of control. It tests a program called "Keeping on Course," which offers strategies and skills to support coping with MCI. The trial involves two groups: one for individuals with MCI and another for their care partners. Ideal participants are MCI patients and their care partners who live together, can communicate in English, and have internet access with separate devices for each person.

As an unphased trial, participants contribute to valuable research that may enhance support strategies for MCI.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on communication skills for those with mild cognitive impairment, so it's unlikely that medication changes are required.

What prior data suggests that this psychoeducation program is safe for individuals with mild cognitive impairment?

Research shows that programs designed for people with mild cognitive impairment (MCI) are generally manageable for participants. Several studies have examined similar programs that assist people with MCI and their caregivers in handling everyday challenges.

For instance, one study found that a multi-part program improved thinking skills like memory and problem-solving without significant side effects. Another study highlighted the benefits of group programs for caregivers, who experienced positive outcomes without negative effects.

Overall, these programs are considered safe. They aim to improve quality of life by enhancing communication and coping skills, with no major risks reported in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Couple in Control Program because it focuses on both individuals with mild cognitive impairment (MCI) and their care partners, unlike most existing treatments that primarily address only the cognitive symptoms of the individual. This program aims to enhance the quality of life and emotional well-being by involving care partners directly, offering a more holistic approach. By empowering both the person with MCI and their care partner, the program hopes to improve coping strategies and daily functioning, which could lead to better outcomes than current options that don't emphasize this collaborative aspect.

What evidence suggests that the Couple in Control Intervention is effective for mild cognitive impairment?

Research has shown that programs designed for couples can assist those dealing with mild cognitive impairment (MCI) by promoting teamwork and engaging them in meaningful activities. In an initial study, couples who participated in these programs felt more supported and better equipped to manage changes over time. This trial will evaluate the Couple in Control Intervention, which aims to enhance communication and provide both the person with MCI and their partner a sense of control. Although the specific benefits of the Couple in Control Intervention are still under investigation, early results suggest that improved communication skills can aid in coping with MCI. ^{1 2 6 7 8}

Who Is on the Research Team?

Kenneth Hepburn, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for pairs (dyads) where one adult has a doctor-confirmed diagnosis of mild cognitive impairment (MCI) and the other is their primary care partner. Both must speak English, live together, have internet access with Zoom-capable devices, and not be prisoners or minors. Pregnant women are excluded.

Inclusion Criteria

Participants must be able to read, speak, and understand English

Recruitment is open to participants throughout the country, including in remote or rural areas

Dyads must live together to provide sufficient opportunity for intervention homework and communication practice activities

Exclusion Criteria

Prisoners

I have MCI and can pass a test proving I understand the study.

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Keeping on Course program, a communication-focused psychoeducation program for dyads coping with mild cognitive impairment

6 weeks

6 virtual group meetings

Follow-up

Participants are monitored for acceptability, feasibility, and preliminary efficacy of the program

8 weeks

Structured quantitative interviews at 4 and 8 weeks post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Couple in Control Intervention

Trial Overview The 'Couple in Control Intervention' is being tested to see if it helps manage MCI through improved communication. Participants will join a virtual advisory board to help develop this program and attend meetings every other week via webinar software.

How Is the Trial Designed?

Group I: Keeping on Course Program for Persons with Mild Cognitive Impairment (MCI) Experimental Treatment 1 Intervention

Persons with MCI participating in the Keeping on Course program.

Group II: Keeping on Course Program for Care Partners of MCI Participants Experimental Treatment 1 Intervention

Care partners participating in the Keeping on Course program with the MCI participant they care for.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Emory Roybal Center for Dementia Caregiving Mastery

Collaborator

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4110106/

Pilot Testing a Couples-focused Intervention for Mild ... DEMA aims to help couples facing MCI supportively work together to meet goals, remain engaged in meaningful activities, and adapt to changes over time.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05423912

Study Details | NCT05423912 | Keeping on Course: A ... The goal of Keeping on Course is to develop and test a psychoeducation program to provide dyads facing mild cognitive impairment (MCI) with communication ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9130435/

Behavioral Interventions in Mild Cognitive Impairment (MCI) Comparative effectiveness of behavioral interventions to mitigate the impacts of degeneration-based cognitive decline is not well understood.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723019632

Cognitive intervention programmes on patients affected by ... This paper examines and reviews studies on the efficacy of computer-based cognitive intervention programmes in the elderly affected by Mild Cognitive ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02083237

Evaluation of an Intervention for Living With Mild Cognitive ... Mild cognitive impairment (MCI) is a significant risk factor for dementia. Persons with MCI experience cognitive changes, most typically affecting memory; ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/1533317513481093

Learning to Live With a Loved One With Mild Cognitive ... This controlled study examines the efficacy of a comprehensive group program aimed at care partners of patients with mild cognitive impairment (MCI), ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2867606/

Experience and Perspectives of Caregivers of Spouse with ... The purpose of this paper is to describe commonalities of the lived experience of being a spouse caregiver of a person with mild cognitive impairment (MCI).

8. psychiatrist.com psychiatrist.com/jcp/multicomponent-intervention-older-adults-at-risk-dementia/

Effects of a Multicomponent Intervention With Cognitive ... This study showed that the multicomponent intervention was effective in improving cognitive function, including MMSE, memory, executive function ...