Mild Cognitive ImpairmentNCT05423912
Keeping on Course: A Communication-Focused Psychoeducational Program
A study testing Keeping on Course Program in people with Mild Cognitive Impairment, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Keeping on Course Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 8 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Clinic at Executive Park
Atlanta, Georgia, 30329
About this study
Official title: Keeping on Course: A Communication-Focused Psychoeducation Program for Dyads Coping With Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Keeping on Course Program
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keeping on Course ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Keeping on Course Program for Persons with Mild Cognitive Impairment (MCI) | Experimental | Persons with MCI participating in the Keeping on Course program. Receives: Behavioral: Keeping on Course Program |
| Keeping on Course Program for Care Partners of MCI Participants | Experimental | Care partners participating in the Keeping on Course program with the MCI participant they care for. Receives: Behavioral: Keeping on Course Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM) Score
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.
Measured: 4 weeks post-program, 8 weeks post-program
Intervention Appropriateness Measure (IAM) Score
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.
Measured: 4 weeks post-program, 8 weeks post-program
Awareness, Courage, and Responsiveness Scale Score
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.
Measured: 4 weeks post-program, 8 weeks post-program
Feasibility of Intervention Measure (FIM) Score
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.
Measured: 4 weeks post-program, 8 weeks post-program
Attendance
Feasibility of the intervention is assessed with the number of sessions attended.
Measured: Up to Week 6
Completion of Homework Assignments
Feasibility of the intervention is assessed with the number of homework assignments completed.
Measured: Up to Week 6
Group Participation
Feasibility of the intervention is assessed with the number of participants engaging in group activities.
Measured: Up to Week 6
Percent of Participants Completing Surveys
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.
Measured: Baseline, 4 weeks post-program, 8 weeks post-program
Secondary outcomes (5)
Perceived Stress Scale (PSS-14) Score Among Care Partners
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.
Measured: Baseline, 4 weeks post-program, 8 weeks post-program
Midlife Development Inventory (MIDI) Sense of Control Scale
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.
Measured: Baseline, 4 weeks post-program, 8 weeks post-program
Decision-Making Involvement Scale
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.
Measured: Baseline, 4 weeks post-program, 8 weeks post-program
Decision-Making Involvement Measure
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.
Measured: Baseline, 4 weeks post-program, 8 weeks post-program
Decision-Making Involvement Measure - Overall Satisfaction
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.
Measured: Baseline, 4 weeks post-program, 8 weeks post-program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start8 Feb 2023
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are 24 dyads of persons with MCI and their care partners who experience the same intervention.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Emory Roybal Center for Dementia Caregiving Mastery
- Responsible party
- Principal investigator, Kenneth Hepburn, Emory University
- Investigators
- Kenneth Hepburn, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423912
- Sponsor's protocol ID
- STUDY00003645
- Other IDs
- P30AG064200
- Status last verified
- Jan 2026
- First submitted
- 1 Jun 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified dataset, including common measures of care partner self-efficacy and mastery, as well as certain demographic data, will be made available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping on Course: A Communication-Focused Psychoeducation Program for Dyads Coping With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05423912
- Acronym / sponsor ID
- STUDY00003645
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Emory Roybal Center for Dementia Caregiving Mastery
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are 24 dyads of persons with MCI and their care partners who experience the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Keeping on Course Program for Persons with Mild Cognitive Impairment (MCI) | Experimental | Behavioral: Keeping on Course ProgramPersons with MCI participating in the Keeping on Course program. |
| Keeping on Course Program for Care Partners of MCI Participants | Experimental | Behavioral: Keeping on Course ProgramCare partners participating in the Keeping on Course program with the MCI participant they care for. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Keeping on Course ProgramMCI 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. | Behavioural | Keeping on Course Program for Care Partners of MCI Participants, Keeping on Course Program for Persons with Mild Cognitive Impairment (MCI) |
Primary outcome
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.
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.
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.
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.
Attendance
Time frame: Up to Week 6
Feasibility of the intervention is assessed with the number of sessions attended.
Completion of Homework Assignments
Time frame: Up to Week 6
Feasibility of the intervention is assessed with the number of homework assignments completed.
Group Participation
Time frame: Up to Week 6
Feasibility of the intervention is assessed with the number of participants engaging in group activities.
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.
5 secondary outcomes
Perceived Stress Scale (PSS-14) Score Among Care Partners
Time frame: Baseline, 4 weeks post-program, 8 weeks post-program
Midlife Development Inventory (MIDI) Sense of Control Scale
Time frame: Baseline, 4 weeks post-program, 8 weeks post-program
Decision-Making Involvement Scale
Time frame: Baseline, 4 weeks post-program, 8 weeks post-program
Decision-Making Involvement Measure
Time frame: Baseline, 4 weeks post-program, 8 weeks post-program
Decision-Making Involvement Measure - Overall Satisfaction
Time frame: Baseline, 4 weeks post-program, 8 weeks post-program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes. The de-identified dataset, including common measures of care partner self-efficacy and mastery, as well as certain demographic data, will be made available for sharing with other researchers.
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Hepburn, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keeping on Course Program in people with Mild Cognitive Impairment, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) Score (time frame: 4 weeks post-program, 8 weeks post-program). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.