The Couple in Control

Mild Cognitive Impairment Clinical Trial

Official title: The Couple in Control: A Communication-Focused Psychoeducation Program for Dyads Coping With Mild Cognitive Impairment

Status Recruiting

Clinical Trial Summary

Approximately one-fifth of community dwelling older adults exhibits mild cognitive impairment (MCI), and despite this being an early caregiving role, assisting a person with MCI is stressful and challenging. The purpose of this study is to develop and pilot test a communication-based psychoeducation program for persons with MCI and their care partners to improve their interpersonal management of MCI. The study team will be recruiting 30 adults throughout the US, though predominantly in GA, to serve on a virtual advisory board, which will meet every other week via webinar software to develop a virtual psychoeducation program for care partner dyads.

Clinical Trial Description

Approximately one-fifth of community dwelling older adults exhibits mild cognitive impairment (MCI), and despite this being an early caregiving role, assisting a person with MCI is stressful and challenging. The purpose of this study is to develop and pilot test a communication-based psychoeducation program for persons with MCI and their care partners to improve their interpersonal management of MCI. The investigators will be recruiting 30 adults throughout the US, though predominantly in GA, to serve on a virtual advisory board, which will meet every other week via webinar software to develop a virtual psychoeducation program for care partner dyads. Advisory board members will include persons with MCI and care partners for persons with MCI. Advisory Board recruitment will be made directly by investigators via phone or email.

In the second phase of the study, the study team will test the virtual program developed through the advisory board in four groups of 6 MCI/care partner dyads (n=48). Study information and recruitment materials will be sent to neurology partners throughout Georgia to make study information available to any interested patients with MCI. Verbal consent will be obtained by investigators over the phone or through webinar software, and participants will complete surveys through RedCAP software baseline, 4 weeks post-, and 8 weeks post-intervention. A subsample of n=30 intervention participants will be invited to engage in a virtual interview with staff to examine the feasibility and acceptability of their intervention experience. Total respondent burden for advisory board members won't exceed 36 hours; and respondent burden for intervention participants (including those doing interviews) will not exceed 26 hours.

Data will not be made publicly available, and participants will be assigned a coded identifier with the password-protected document containing the key stored separately from data files. Designated study staff will have access to this key. All study files will require a password for access, and only study personnel will have access to the file passwords. Audio recordings will be destroyed following completion of the study and transcription of the interviews. As the study is virtual, all quantitative data will be collected online, and interviews will be conducted through webinar software. The scope of topic areas covered in the advisory board, intervention, and interviews will pertain to experiences, challenges, and coping strategies of persons with MCI and their care partners. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT05423912
• Study type: Interventional
• Source: Emory University
• Contact: Lindsay Prizer, PhD
• Phone: 678-788-3128
• Email: lprizer@emory.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2023
• Completion date: May 2024