Keeping on Course: A Communication-Focused Psychoeducational Program

NCT05423912 | Completed

• 2 other identifiers: STUDY00003645P30AG064200
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  4 weeks post-program, 8 weeks post-program

• Attendance

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

  Up to Week 6

• Completion of Homework Assignments

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

  Up to Week 6

• Group Participation

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

  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.

  Baseline, 4 weeks post-program, 8 weeks post-program

Secondary Outcomes (5)

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

  Baseline, 4 weeks post-program, 8 weeks post-program

• Midlife Development Inventory (MIDI) Sense of Control Scale

  Baseline, 4 weeks post-program, 8 weeks post-program

• Decision-Making Involvement Scale

  Baseline, 4 weeks post-program, 8 weeks post-program

• Decision-Making Involvement Measure

  Baseline, 4 weeks post-program, 8 weeks post-program

• Decision-Making Involvement Measure - Overall Satisfaction

  Baseline, 4 weeks post-program, 8 weeks post-program

Study Arms (2)

Keeping on Course Program for Persons with Mild Cognitive Impairment (MCI)

EXPERIMENTAL

Persons with MCI participating in the Keeping on Course program.

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.

Behavioral: Keeping on Course Program

Interventions

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.

Keeping on Course Program for Care Partners of MCI Participants; Keeping on Course Program for Persons with Mild Cognitive Impairment (MCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator
• Emory Roybal Center for Dementia Caregiving Mastery: collaborator

Study Sites (1)

Emory Clinic at Executive Park

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kenneth Hepburn, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are 24 dyads of persons with MCI and their care partners who experience the same intervention.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 21, 2022
• Study Start: February 8, 2023
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available for sharing once the main findings from this study are published.
• Access Criteria: Data from this pilot study will be available to qualified researchers through a data sharing agreement that is fully consistent with NIH data sharing policies and applicable laws and regulations as well as official policies and practices established. Study data will be deposited in the Roybal Center data repository. Data will be made available to qualified researchers via an NIH-approved data sharing agreement. The data sharing agreement will require: 1. a commitment only to use the data for research purposes and not to identify any individual participant; 2. a commitment to securing the data using appropriate computer technology; and 3. a commitment to destroy or return the data after analyses are completed. Analyses will be up to the discretion of the requesting researcher and restrictions outlined in the data sharing agreement.

Locations

US (1)