National Institute of Nursing Research (NINR) #R01 NR009077: Problem-solving: A Stroke Caregiver Early Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 8
- 主要终点
- Bakas Caregiving Outcomes Scale (BCOS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors were blind to the group assignment of participants. The study group was not entered in the data entry program.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Bakas Caregiving Outcomes Scale (BCOS)
时间窗: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
The Bakas Caregiving Outcomes scale (BCOS) measures changes in social functioning, subjective well-being, and somatic health 37. The 16-items with a 7-point response set, 1 ="Changed for the Worst" to 7 ="Changed for the Best" are summed for an overall score that reflect CG life changes. Construct validity was supported by a uni-dimensional factor analysis solution and prediction of the BCOS by stress and coping variables. Criterion validity was supported by significant correlations with a well-being measure.
The Center for Epidemiologic Studies Depression scale (CES D)
时间窗: Enrollment, post-intervention (WLC=3 months), 6 months, 12 months post discharge
The CES D was developed to study depressive symptomatology in community settings. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the past week.
The Functional Independence Measure (FIM)
时间窗: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
The FIM measures severity of disability and resultant care burden on six subscales: self care, sphincter control, mobility, locomotion, communication, and social cognition. It uses an 18 item, 7 point scale, 1="maximum dependence" to 7 = "independent function". Two underlying constructs have been identified, a 13-item motor scale and a 5-item cognitive scale (two language and three social cognition items).
Social Problem Solving (SPSI-R)
时间窗: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
The Social Problem Solving (SPSI-R) short form will be used to assess problem-solving. This 25-item scale contains five subscales that measure two problem-oriented dimensions (positive, negative) and three problem-solving styles (impulsive/careless, avoidance, rational). The responses range from (0= not true to 4= extremely true).
Profile of Moods Scale short form (POMS)
时间窗: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
The Profile of Moods Scale short form (POMS) is a 30 item scale that uses a 5 point response set (0 = not at all, 4 = extremely) to assess 6 moods. Predictive, construct, and concurrent validity have been demonstrated. Only the Anxiety sub-scale will be evaluated.
The Preparedness for Caregiving Scale
时间窗: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
The Preparedness for Caregiving Scale (PCS)assesses a caregiver's perception of how well prepared they are to manage the tasks and stresses of caregiving. The PCS has been used in studies of CGs of persons with a variety of health needs. It is an 8-item, 5-response option scale (0=not at all prepared to 4=very well prepared).
The General Functioning Scale of the McMaster Family Assessment Device (FAD)
时间窗: Enrollment, post-intervention (WLC=3 months), 6 months,12 months post discharge
This 12 item, 4 point subscale assesses overall health/pathology of the family. The range of scores is 1=healthy to 4=unhealthy. Concurrent validity was supported by predicting 28% of the variance in marital satisfaction. The FAD predicted 17% to 22%, respectively, of the variance in morale scores of husbands and wives. The FAD has been used in stroke studies, was sensitive to change over time and to interventions, and predicted depression.
次要结局
- Unmet Resource Needs (URN)(Pre-discharge; 3, 6 and 12 months post discharge)
- The Center for Epidemiologic Studies Depression scale (CES D) - Patient(Pre-discharge; 3, 6 and 12 months post discharge)
- The Appraisal of Caregiving Scale Revised (ACS-R)(Pre-discharge; 3, 6 and 12 months post discharge)
研究者
Rosemarie King
Rosemarie B. King, PhD, RN Research Professor Northwestern University Feinberg School of Medicine
Northwestern University