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Completed

NCT Number: NCT05423912

Keeping on Course: A Communication-Focused Psychoeducational Program

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Clinic at Executive Park

Atlanta, Georgia, 30329, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Keeping on Course Program

Behavioral

MCI dyads engaging in the testing aim of the Keeping on Course Program take part in group meetings lasting 90 to 120 minutes over the course of 6 virtual meetings. Participants are asked to take part in structured quantitative interviews at baseline and 4 and 8 weeks post-intervention. A subsample of participants will be invited to take part in a virtual, semi-structured 30-60 minute qualitative interview focused on their experiences in and perceptions of the intervention.

Primary outcomes

  1. Acceptability of Intervention Measure (AIM) Score

    Time frame: 4 weeks post-program, 8 weeks post-program

    Acceptability, appropriateness, and feasibility of the Keeping on Course program are assessed with three items from the Acceptability of Intervention Measure (AIM). Items are scored on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. The total score is the average score of all items and ranges from 1 to 5. Higher scores indicate greater acceptability of the intervention.

  2. Intervention Appropriateness Measure (IAM) Score

    Time frame: 4 weeks post-program, 8 weeks post-program

    Appropriateness of the Keeping on Course program is assessed with three items from the Intervention Appropriateness Measure (IAM). Items are scored on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. The total score is the average score of all items and ranges from 1 to 5. Higher scores indicate greater appropriateness of the intervention.

  3. Awareness, Courage, and Responsiveness Scale Score

    Time frame: 4 weeks post-program, 8 weeks post-program

    The Awareness, Courage, and Responsiveness Scale asks 24 questions to measure awareness of others, self-awareness, courage, and responsiveness towards others. Responses to survey items are given on a 7-point scale where "never true" = 1 and "always true" = 7. The total score ranges from 24 to 168. Higher scores indicate greater expression of interpersonal dynamics of being aware, courageous in uncomfortable situations, and being responsive to the needs of others.

  4. Feasibility of Intervention Measure (FIM) Score

    Time frame: 4 weeks post-program, 8 weeks post-program

    Feasibility of the Keeping on Course program is assessed with three items from the Feasibility of Intervention Measure (FIM). Items are scored on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. The total score is the average score of all items and ranges from 1 to 5. Higher scores indicate greater feasibility of the intervention.

  5. Attendance

    Time frame: Up to Week 6

    Feasibility of the intervention is assessed with the number of sessions attended.

  6. Completion of Homework Assignments

    Time frame: Up to Week 6

    Feasibility of the intervention is assessed with the number of homework assignments completed.

  7. Group Participation

    Time frame: Up to Week 6

    Feasibility of the intervention is assessed with the number of participants engaging in group activities.

  8. Percent of Participants Completing Surveys

    Time frame: Baseline, 4 weeks post-program, 8 weeks post-program

    Acceptability of measurements used to understand decision-making in dyads coping with MCI is assessed as the completion rates of each of four instruments. An instrument is considered acceptable if there is a 90% completion rate for an instrument.

Secondary outcomes

  1. Perceived Stress Scale (PSS-14) Score Among Care Partners

    Time frame: Baseline, 4 weeks post-program, 8 weeks post-program

    The 14-item Perceived Stress Scale (PSS-14) is a measure of the degree to which situations in one's life are appraised as stressful. Care Partner participants are asked questions about their thoughts and feelings during the last month. Responses are given on a 5-point scale where "never" is scored as 0 and "very often" is scored as 4. Total scores range from 0 to 56 with higher scores indicating greater perceived stress.

  2. Midlife Development Inventory (MIDI) Sense of Control Scale

    Time frame: Baseline, 4 weeks post-program, 8 weeks post-program

    The Midlife Development Inventory (MIDI) Sense of Control Scale asks respondents to assess their sense of control over their life. The 12 items are responded to on a 7-point scale where "strongly agree" = 1 and "strongly disagree" = 7. A total score is obtained by calculating the average score of all items. When calculating a total score, certain items are reversed. Total scores range from 1 to 7 with lower scores indicate greater sense of control over life.

  3. Decision-Making Involvement Scale

    Time frame: Baseline, 4 weeks post-program, 8 weeks post-program

    The Decision-Making Involvement Scale is administered to participants with MCI and their care providers. The instrument assesses the agency in personal decision-making of the person living with mild cognitive impairment with 5 items. Responses to items are given on a 4-point scale where "not at all involved" = 0 and "very involved" = 3. Total scores range from 0 to 15 with higher scores indicating the participant with MCI has greater involvement with personal decision-making.

  4. Decision-Making Involvement Measure

    Time frame: Baseline, 4 weeks post-program, 8 weeks post-program

    A modified version of the Decision-Making Involvement Measure is used in this study to assess participation in the discussions during the Keeping on Course program. The first five items are responded to on a 4-point scale where "none/never" = 1 and "all/always" = 4. Total scores range from 5 to 20 with higher scores indicating greater feelings of involvement in the program discussions.

  5. Decision-Making Involvement Measure - Overall Satisfaction

    Time frame: Baseline, 4 weeks post-program, 8 weeks post-program

    A modified version of the Decision-Making Involvement Measure is used in this study to assess participation in the discussions during the Keeping on Course program. Item 6 asks participants how satisfied they were with the series of discussions overall. Responses are given on a 7-point scale where "not very well at all" = 0 and "very well indeed" = 6.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Emory Roybal Center for Dementia Caregiving Mastery
  • National Institute on Aging (NIA)

Registry information

Official study title

Keeping on Course: A Communication-Focused Psychoeducation Program for Dyads Coping With Mild Cognitive Impairment

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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