Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01141738
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2010-05-10
Brief Title:
Problem-solving A Stroke Caregiver Early Intervention
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
National Institute of Nursing Research NINR R01 NR009077 Problem-solving A Stroke Caregiver Early Intervention
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPSI
Brief Summary:
Intervention studies for stroke caregivers CGs during early caregiving are few and have met with limited success The Post-Stroke Rehabilitation Clinical Practice Guidelines 1995 recommend sensitivity to the adverse effects of caregiving on family functioning and CG health Breakdown of the informal care system can lead to premature introduction of formal services excess disability and decline in well-being for stroke survivor and CG alike Thus it is important to attempt to prevent the chronic distress of stroke CGs through an early intervention that prevents and remediates distress coaches problem-solving and other coping skills can affect multiple outcomes has durable effects and is non-threatening and accessible The proposed intervention will incorporate these features and will be low cost and feasible for use in clinical practice it will target outcomes important to stroke CGs depression anxiety caregiver preparedness perceptions of life changes family functioning and survivor functioning The individual format will make it possible to address life stage needs and cultural issues Given the prevalence of distress in chronic stroke CGs early intervention to prevent and mediate negative outcomes is essential The proposed study will therefore test the efficacy of an early intervention for stroke survivor caregivers that provides structured information on problem-solving and resources guided problem-solving in the context of a supportive relationship and training in skills to cope with stress and emotions The intervention will be tailored based on assessment data will begin during acute rehabilitation and will extend through the most stressful caregiving phase The study will use a two-group design the experimental caregiver problem-solving intervention CPSI group and a wait-list control WLC group to examine the effectiveness of the CPSI in reducing CG depressive symptoms and anxiety improving caregiver preparedness perception of life changes family functioning and stroke survivor functional status Qualitative methods will be used to gain insight into why the CPSI works for some CGs and not others
Detailed Description:
Caregivers CGs of stroke survivors assume their role suddenly and with little preparation Negative emotions are common persist over time and are related to other negative outcomes poor survivor function decreased family functioning Early intervention to prevent chronic distress is uncommon This randomized mixed-method treatment-control trial guided by a coping model will test a caregiver problem-solving intervention CPSI The aims are to 1 test the effect of CPSI on CG depressive symptoms anxiety preparedness perceptions of life changes family functioning and survivor function during the first year of caregiving 2 examine the mediation effects of appraisal of caregiving and problem-solving and 3 describe the experience of being a CG and the experience of the intervention in CPSI CGs who are positive or negative responders on depressive symptoms Stroke survivor-caregiver dyads N 280 will be randomly assigned to the CPSI or a waitlist control condition WLC The CPSI includes 2 sessions during acute rehabilitation and 8 telephone sessions through 3 months post-discharge with problem-solving tailored to the CGs priorities and training in coping skills To test its effectiveness data will be collected on survivor and CG contextual factors and mediating and outcome variables at baseline post-intervention and 6 months and 1 year post-discharge The WLC CGs will be offered an intervention 6 months post-discharge CPSI caregivers will be purposively sampled 1 year post-discharge based on changes in depressive symptoms and interviewed about their experiences and responses to the intervention Exploratory data will be collected on CG health behaviors and survivor depressive symptoms hospitalization institutionalization and mortality Multivariate analysis of variance and regression techniques will be used to assess CPSI effects on CG outcomes and survivor function and on mediators respectively Qualitative data will be analyzed using content analysis Descriptive and univariate statistics will be used to assess the exploratory data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None