Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05423912
Status:
SUSPENDED
Last Update Posted:
2024-07-08
First Post:
2022-06-01
Brief Title:
The Couple in Control A Communication-Focused Program
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
The Couple in Control A Communication-Focused Psychoeducation Program for Dyads Coping With Mild Cognitive Impairment
Status:
SUSPENDED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study recruitment is paused due to changes in staffing and funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to develop and pilot test a communication-based psychoeducation program for persons with mild cognitive impairment MCI and their care partners to improve their interpersonal management of 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 dont 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 Alzheimers 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 For the dyad and both parties in an MCI couple 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 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 HIVAIDS 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 The Couple in Control CiC 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 prepost 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 CiC program Participants meet in virtual intervention group meetings over the course of 8 to 9 consecutive weeks and take part in structured quantitative interviews prior to the intervention and then 4 and 8 weeks post-intervention
For most diagnosed with MCI the experience is shared with another typically a spouse or partner For the dyad and both parties in an MCI couple 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 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 HIVAIDS 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 The Couple in Control CiC 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 prepost 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 CiC program Participants meet in virtual intervention group meetings over the course of 8 to 9 consecutive weeks and take part in structured quantitative interviews prior to the intervention and then 4 and 8 weeks post-intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30AG064200 | NIH | None | httpsreporternihgovquickSearchP30AG064200 |