Keeping on Course: A Communication-Focused Psychoeducational Program
- Conditions
- Mild Cognitive Impairment
- Registration Number
- NCT05423912
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Acceptability of Intervention Measure (AIM) Score 4 weeks post-program, 8 weeks post-program Acceptability, appropriateness, and feasibility of the Keeping on Course program is 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.
Intervention Appropriateness Measure (IAM) Score 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.
Feasibility of Intervention Measure (FIM) Score 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.
Attendance Up to Week 6 Feasibility of the intervention is assessed with the number of sessions attended.
Completion of Homework Assignments Up to Week 6 Feasibility of the intervention is assessed with the number of homework assignments completed.
Group Participation Up to Week 6 Feasibility of the intervention is assessed with the number of participants engaging in group activities.
Percent of Participants Completing Surveys 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 Outcome Measures
Name Time Method Change in Perceived Stress Scale (PSS-14) Score Among Care Partners 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.
Midlife Development Inventory (MIDI) Sense of Control Scale 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.
Decision-Making Involvement Scale 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 the participant with MCI has greater involvement with personal decision-making.
Decision-Making Involvement Measure 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.
Decision-Making Involvement Measure - Overall Satisfaction 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.
Trial Locations
- Locations (1)
Emory Clinic at Executive Park
🇺🇸Atlanta, Georgia, United States
Emory Clinic at Executive Park🇺🇸Atlanta, Georgia, United States