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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423912
• Other study ID #: STUDY00003645
• Secondary ID: P30AG064200
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2023
• Source: Emory University
• Contact: Lindsay Prizer, PhD
• Phone: 678-788-3128
• Email: lprizer[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dyads composed individuals with a clinician-confirmed diagnosis of MCI and a primary 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.

• The virtual format of the intervention allows for recruitment of participants throughout the country, including in remote or rural areas.

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Couple in Control Intervention
To assess the acceptability, feasibility, and preliminary efficacy in 4 cohorts of 6 MCI dyads each (N-48 individuals) to take part in a trial of the CiC program. Participants engaging in the pilot testing aim of the project will meet in 90-120-minute virtual intervention group meetings over the course of 8-9 consecutive weeks (depending on the program finalization to occur through Objective 1 activities). They will be asked to take part in structured quantitative interviews pre-intervention and then 4 and 8 weeks post-intervention. A purposive convenience subsample of intervention participants will be interviewed virtually over Zoom videoconference for one 30-60 minute discussion on their experiences in and perceptions of the intervention. Interview durations will be based on the participant's verbosity of response, and participants can end the interview at any point or choose to schedule a follow up call to continue the interview later should they become fatigued.

Locations

Country	Name	City	State
United States	Executive Park	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Care Partner Self Assessment of their Caregiver competency (Pearlin's Competence Scale)	Mastery will be assessed using the 4-item Pearlin mastery sub-scale on competence. Assuming baseline scores on the primary endpoint (Pearlin's competence subscale) is 12 with a standard deviation of 2, then scores must increase by one point on average after 8 sessions to ensure adequate power	At baseline, at 4 and at 8 weeks post-program
Primary	Changes in Feasibility of the intervention as determined through qualitative interviews	To evaluate the feasibility of the prototype Couple in Control program using quantitative approaches with four groups of 6 MCI couples each (N=24 dyads/48 individuals) and establish the acceptability of the program through qualitative interviews with a sub-sample (n=20) of participants.; Feasibility of intervention will be evaluated by the extent to which the intervention can be implemented as planned. Participant attendance, completion of homework assignments, and group participation will be collected to assess intervention feasibility. Preliminary efficacy, focusing on mastery, perceived control, and relational uncertainty will be evaluated as the primary outcome.	At baseline, at 4 and at 8 weeks post-program
Secondary	Changes Impact of the intervention on stress (10-item Perceived Stress Scale)	Impact of the Intervention will be assessed with the Perceived Stress Scale (PSS) It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress.; PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.	at baseline, at 4 and at 8 weeks post-program
Secondary	Changes to Center for Epidemiological Studies - Depression Scale (CESD)	The Center for Epidemiological Studies-Depression (CES-D), is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	at baseline, at 4 and at 8 weeks post-program
Secondary	Changes in Dyadic Relationship Scale	The Dyadic Relationship Scale (DRS), measures positive and negative aspects of the dyadic relationship intrinsic to family care. Experts developed and revised this tool to measure appraisals of family care relationships from the perspective of each individual.; The instrument will be administered both patient and caregiver versions that included a four-option response (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). The patient version (10 items) and the caregiver version (11 items) have two subscales: dyadic strain and positive dyadic interaction. Higher scores on each of these scales indicate higher levels of strain and positive interaction, respectively.	at baseline, at 4 and at 8 weeks post-program