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Couple in Control Program for Mild Cognitive Impairment
N/A
Recruiting
Led By Lindsay Prizer, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, at 4 and at 8 weeks post-program
Awards & highlights
Study Summary
This trial will develop and test a communication-based psychoeducation program to help improve the interpersonal management of mild cognitive impairment for the sufferers and their care partners.
Who is the study for?
This trial is for pairs (dyads) where one adult has a doctor-confirmed diagnosis of mild cognitive impairment (MCI) and the other is their primary care partner. Both must speak English, live together, have internet access with Zoom-capable devices, and not be prisoners or minors. Pregnant women are excluded.Check my eligibility
What is being tested?
The 'Couple in Control Intervention' is being tested to see if it helps manage MCI through improved communication. Participants will join a virtual advisory board to help develop this program and attend meetings every other week via webinar software.See study design
What are the potential side effects?
Since this intervention involves psychoeducation rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or stress during discussions about managing MCI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, at 4 and at 8 weeks post-program
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, at 4 and at 8 weeks post-program
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Care Partner Self Assessment of their Caregiver competency (Pearlin's Competence Scale)
Changes in Feasibility of the intervention as determined through qualitative interviews
Secondary outcome measures
Changes Impact of the intervention on stress (10-item Perceived Stress Scale)
Changes in Dyadic Relationship Scale
Changes to Center for Epidemiological Studies - Depression Scale (CESD)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Person living with MCI participantExperimental Treatment1 Intervention
All participants will be asked to complete the quantitative endpoint measures at baseline and 4 and 8 weeks after the end of the course. These measures will be administered verbally by a study staff member by phone (20-30 minutes) or Zoom call to ensure survey questions are clear and participants' questions are answered. These quantitative measures will assess the effect of the program on participants' sense of mastery or control over caregiving tasks as well as their emotional well-being and communication. In addition, qualitative semi-structured interviews will be conducted following program participation. These interviews will focus on participants' perceptions of the effect of the program on them but will also seek information that might help to further strengthen the program.
Group II: Mild Cognitive Impairment (MCI) ParticipantExperimental Treatment1 Intervention
All participants will be asked to complete the quantitative endpoint measures at baseline and 4 and 8 weeks after the end of the course. These measures will be administered verbally by a study staff member by phone (20-30 minutes) or Zoom call to ensure survey questions are clear and participants' questions are answered. These quantitative measures will assess the effect of the program on participants' sense of mastery or control over caregiving tasks as well as their emotional well-being and communication. In addition, qualitative semi-structured interviews will be conducted following program participation. These interviews will focus on participants' perceptions of the effect of the program on them but will also seek information that might help to further strengthen the program
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,958 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,684 Previous Clinical Trials
28,025,879 Total Patients Enrolled
Lindsay Prizer, PhDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have MCI and can pass a test proving I understand the study.I am under the age of 18.I cannot fully understand or speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Mild Cognitive Impairment (MCI) Participant
- Group 2: Person living with MCI participant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining openings in this experiment that individuals can participate in?
"This research project is not actively recruiting patients, as per the information available on clinicaltrials.gov. The trial was initially posted in October 1st of 2022 and its latest update occurred on July 27th of the same year. Nevertheless, there are still 569 active trials searching for participants at this moment."
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