Clinical trial NCT05423912: Keeping on Course: A Communication-Focused Psychoeducational Program
Official title: Keeping on Course: A Communication-Focused Psychoeducation Program for Dyads Coping With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Emory Roybal Center for Dementia Caregiving Mastery
First posted: 2022-06-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are 24 dyads of persons with MCI and their care partners who experience the same intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of Keeping on Course is to develop and test a psychoeducation program to provide dyads facing mild cognitive impairment (MCI) with communication skills and strategies that will establish or restore a sense of agency as they cope with MCI.

Detailed description: Up to 21% of older adults exhibit symptoms of mild cognitive impairment (MCI), a term used to describe a compilation of cognitive and behavioral symptoms that approach but don't meet the threshold for a dementia diagnosis. Noticeably characterized by losses in executive function and memory that can affect critical life domains like employment, housing, health care, and finances, it is also a life condition of considerable indeterminacy both for the person living with the condition and for care partners. While many individuals experience worsened symptoms leading to an Alzheimer's disease (AD) diagnosis within five years, MCI can be caused by a variety of disease processes making disease trajectory and prognosis vague and uncertain.

For most diagnosed with MCI, the experience is shared with another, typically a spouse or partner. In many cases, other members of the family, including fictive kin, are part of the team providing care and support - not only to the person living with MCI but to the principal caregiver, as well. For the dyad and both parties in an MCI couple individually, the period following an MCI diagnosis is often one of extended emotional turbulence and ambiguity. Care partner dyads coping with MCI face changes in role identity resulting in significant consequences for relationships, and the turbulence extends beyond the dyad to the larger extended family. It is unclear what the future might hold or how pervasively established patterns of living will be altered. The foundations of shared expectations and of trustworthy methods of planning, communication, and decision-making are disrupted in unpredictable ways. Emotional adjustment to MCI, unique for each dyad, has implications for subsequent family coping, psychological stress, physical fatigue, social isolation, decision-making, financial well-being, and more.

While MCI psychoeducation programs exist, they almost always target the person with MCI and not the patient-care partner dyad. Communication patterns between patients and care partners in oncology and HIV/AIDS settings are shown to influence the coping and care outcomes of dyads. With similar communication issues noted in MCI dyads, the goal of this pilot project is to develop and test the feasibility and preliminary efficacy and evaluate acceptability of a group program, Keeping on Course, to provide couples facing MCI with communication skills and interpersonal strategies that will establish or restore a sense of agency and emotional well-being as they navigate this period of transition and uncertainty.

This study uses a one-arm, pre/post design to assess the acceptability, feasibility, and preliminary efficacy in 4 cohorts of 6 MCI dyads each (for a total of 48 individuals) to take part in a trial of the Keeping on Course program. Participants meet in virtual intervention group meetings over the course of 6 consecutive weeks. Participants are asked to take part in structured quantitative interviews prior to the intervention and then 4 and 8 weeks post-intervention.

Eligibility criteria: Inclusion Criteria:

* Either a person with MCI, defined as a score of 23-27 on the Mini-Mental State Examination (MMSE) or a score of 19-25 on the Montreal Cognitive Assessment (MoCA), or an MCI care partner
* Can read, speak, and understand English
* Have internet connectivity and a separate zoom-enabled device for each dyad member
* Dyads must live together, as this will provide sufficient opportunity for intervention homework and communication practice activities

Exclusion Criteria:

* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Individuals who are not able to clearly understand and speak English
* Those living with MCI will need to successfully complete a capacity to consent survey to be included in the study

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: 4 weeks post-program, 8 weeks post-program
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: 4 weeks post-program, 8 weeks post-program
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: 4 weeks post-program, 8 weeks post-program
measure: Attendance
timeFrame: Up to Week 6
measure: Completion of Homework Assignments
timeFrame: Up to Week 6
measure: Group Participation
timeFrame: Up to Week 6
measure: Percent of Participants Completing Surveys
timeFrame: Baseline, 4 weeks post-program, 8 weeks post-program
Secondary outcomes:
measure: Change in Perceived Stress Scale (PSS-14) Score Among Care Partners
timeFrame: Baseline, 4 weeks post-program, 8 weeks post-program
measure: Midlife Development Inventory (MIDI) Sense of Control Scale
timeFrame: Baseline, 4 weeks post-program, 8 weeks post-program
measure: Decision-Making Involvement Scale
timeFrame: Baseline, 4 weeks post-program, 8 weeks post-program
measure: Decision-Making Involvement Measure
timeFrame: Baseline, 4 weeks post-program, 8 weeks post-program
measure: Decision-Making Involvement Measure - Overall Satisfaction
timeFrame: Baseline, 4 weeks post-program, 8 weeks post-program
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic at Executive Park
state: Georgia
Study officials:
affiliation: Emory University
name: Kenneth Hepburn, PhD
role: PRINCIPAL_INVESTIGATOR
References: