Clinical trial NCT01141738: Problem-solving: A Stroke Caregiver Early Intervention
Official title: National Institute of Nursing Research (NINR) #R01 NR009077: Problem-solving: A Stroke Caregiver Early Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Adaptation
Keywords: stroke
caregiver
depression
mediators
problem-solving
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
name: Alexian Brothers Hospital Network
name: Wake Forest University Health Sciences
name: Sinai Chicago/Schwab Rehabilitation
First posted: 2010-06-10
Enrollment: 362
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consenting participants were assigned randomly, using a computer-generated assignment program, to either the Caregiver Problem-Solving Intervention (CPSI) or to a Wait-List control group.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Caregiver and stroke survivor aged 21 or older. If the stroke survivor does not participate, the caregiver remains eligible.
* Primary caregiver for and living with an adult survivor who is hospitalized for a recent stroke and who is planning to return home from acute rehabilitation.

Exclusion Criteria:

* Caregivers who are diagnosed with a major psychiatric disorder and/or in individual, group or supportive therapies will be excluded from the study; however, only caregivers who obtain a score of 10 or greater on the study depression measure (CES-D) will be included.
* Subjects also will require sufficient hearing and telephone access to be available for the phone segment of the intervention and assessment.

Primary outcomes:
measure: The Center for Epidemiologic Studies Depression scale (CES D)
timeFrame: Enrollment, post-intervention (WLC=3 months), 6 months, 12 months post discharge
measure: Profile of Moods Scale short form (POMS)
timeFrame: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
measure: The Preparedness for Caregiving Scale
timeFrame: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
measure: Bakas Caregiving Outcomes Scale (BCOS)
timeFrame: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
measure: The General Functioning Scale of the McMaster Family Assessment Device (FAD)
timeFrame: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
measure: The Functional Independence Measure (FIM)
timeFrame: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
measure: Social Problem Solving (SPSI-R)
timeFrame: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
Secondary outcomes:
measure: Unmet Resource Needs (URN)
timeFrame: Pre-discharge; 3, 6 and 12 months post discharge
measure: The Appraisal of Caregiving Scale Revised (ACS-R)
timeFrame: Pre-discharge; 3, 6 and 12 months post discharge
measure: The Center for Epidemiologic Studies Depression scale (CES D) - Patient
timeFrame: Pre-discharge; 3, 6 and 12 months post discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Schwab Rehabilitation Hospital
state: Illinois
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago (2017:Shirley Ryan Ability Lab)
state: Illinois
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Hospital Network
state: Illinois
Study officials:
affiliation: Northwestern University
name: Rosemarie B King, R.N., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: King RB, Raad JH, Flaherty J, Hartke RJ. Stroke Caregiver Depression: Qualitative Comparison of Treatment Responders and Nonresponders at 1 Year. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):581-588. doi: 10.1097/JCN.0000000000000852. Epub 2021 Aug 9.
citation: King RB, Ainsworth CR, Ronen M, Hartke RJ. Stroke caregivers: pressing problems reported during the first months of caregiving. J Neurosci Nurs. 2010 Dec;42(6):302-11. doi: 10.1097/jnn.0b013e3181f8a575.
citation: King RB, Hartke RJ, Houle TT. Patterns of relationships between background characteristics, coping, and stroke caregiver outcomes. Top Stroke Rehabil. 2010 Jul-Aug;17(4):308-17. doi: 10.1310/tsr1704-308.
citation: King RB, Hartke RJ, Houle T, Lee J, Herring G, Alexander-Peterson BS, Raad J. A problem-solving early intervention for stroke caregivers: one year follow-up. Rehabil Nurs. 2012 Sep-Oct;37(5):231-43. doi: 10.1002/rnj.039. Epub 2012 Jun 29.
citation: King RB, Hartke RJ, Lee J, Raad J. The stroke caregiver unmet resource needs scale: development and psychometric testing. J Neurosci Nurs. 2013 Dec;45(6):320-8. doi: 10.1097/JNN.0b013e3182a3ce40.