NCT01141738

Problem-solving: A Stroke Caregiver Early Intervention

National Institute of Nursing Research (NINR) #R01 NR009077: Problem-solving: A Stroke Caregiver Early Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

Intervention studies for stroke caregivers (CG's) 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 CG's 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.

Conditions

• Psychological Adaptation

Interventions

Type	Name	Description
BEHAVIORAL	Caregiver Problem-Solving Intervention	Subjects will meet for two counseling sessions while their family member is hospitalized and will receive the treatment manual, which contains the content for the 10 sessions, work sheets, and handouts. The standardized content will be complemented by tailoring to the specific concerns and problems of CGs which are influenced by culture and developmental life stage as well as the stroke and other environmental and personal factors. Problems specific to stroke caregiving are emphasized. After the stroke survivor has been discharged, the counselor will contact the CG weekly by phone for 5 weeks and then bi-weekly for the next three sessions (a total of 10 sessions) at times convenient for the CG.
BEHAVIORAL	Wait List Control	Subjects in the WLC condition will receive usual patient and family education. If these subjects are noted to be distressed when assessment measures are administered or during conversation, the research assistant (RA) will inform the PI or Co-PI, who will follow-up. To aid retention, a counselor who is naïve to the CPSI will call the WLC subjects in the second and fifth months post-discharge to check contact information and ask how they are doing. Access to individual or group therapy through community resources during this study will be monitored during routine data collection. Following the T3 assessment, the WLC subjects will be offered a minimal intervention (receipt of the Adapting to Stress booklet 100 and five 30 minute telephone sessions).

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2010-06-10
• Last updated: 2023-05-22

Locations

4 sites across 1 country: United States