Study protocol of a telephone problem-solving intervention for Spanish-speaking caregivers of veterans post-stroke: an 8-session investigator-blinded, two-arm parallel (intervention vs usual care), randomized clinical trial.

BACKGROUND: Stroke is one of the leading causes of death and the main cause of long-term disability in the United States. The significant risk factors of stroke among Hispanics are well-documented. The majority of stroke survivors return home following a stroke and are cared for by family caregivers. Due to the abrupt nature of strokes, caregivers experience unexpected changes and demands that oftentimes lead to caregiver burden and depression. Given the significant risk factors for stroke in Hispanics and the influence of culture in family norms and family management, we developed a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers. This study tests the impact of a telephone and online problem-solving intervention for Spanish-speaking stroke caregivers on caregiver outcomes. METHODS: The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 290 caregivers from 3 Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a problem-solving intervention that uses telephone and online education and care management tools on the previously developed and nationally available RESCUE en Español Caregiver website. In the usual care group, participants receive the information and/or support caregivers of veterans with stroke normally receive through existing VA resources (e.g., stroke-related information and support). The primary outcome is change in caregiver's depressive symptoms at 1- and 12-weeks post-intervention. Secondary outcomes include changes in stroke caregivers' burden, self-efficacy, problem-solving, and health-related quality of life (HRQOL) and veterans' functional abilities. We will also determine the budgetary impact, the acceptability of the intervention and participation barriers and facilitators for Spanish-speaking stroke caregivers. DISCUSSION: This is an ongoing study. It is the first known randomized controlled trial testing the effect of a telephone and online problem-solving intervention in Spanish for caregivers of veterans post-stroke. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post-stroke. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03142841- Spanish Intervention for Caregivers of Veterans with Stroke (RESCUE Español). Registered on February 23, 2018. Protocol version 8. 08.11.2022.

Effect of a telephone and web-based problem-solving intervention for stroke caregivers on stroke patient activities of daily living: A randomized controlled trial.

OBJECTIVE: To test for effects of a problem-solving intervention for stroke caregivers on stroke survivor activities of daily living. DESIGN: Two-arm parallel randomized clinical trial with repeated measures at 11 weeks and 19 weeks. SETTING: Medical centers for US military Veterans. SUBJECTS: Caregivers of stroke survivors. INTERVENTION: A registered nurse guided caregivers in using problem-solving strategies emphasizing creative thinking, optimism, planning, and expert information to address challenges associated with caregiving. Caregivers in the intervention completed one telephone orientation session followed by eight online, asynchronous messaging center sessions. The messaging center sessions involved (a) education on the Resources and Education for Stroke Caregivers' Understanding and Empowerment website (https://www.stroke.cindrr.research.va.gov/en/), (b) supportive communication between the nurse and caregiver, (c) nurse and caregiver interactions to improve problem-solving, and (d) maintain adherence to discharge planning instructions. MAIN OUTCOME: The Barthel Index was used to measure activities of daily living. RESULTS: 174 participants (standard care n = 88, intervention n = 86) were enrolled at baseline. There were no significant differences between groups at baseline. Change scores in activities of daily living between baseline and 11 weeks were significantly higher in the intervention group than the standard care group (group difference = 6.43, 95% confidence interval: 1.28, 11.58). Group differences in change scores between baseline and 19 weeks were not statistically significant (group difference = 3.89, 95% confidence interval: -3.58, 11.36). CONCLUSIONS: This web-based caregiver intervention improved stroke survivor activities of daily living by 11 weeks, but intervention effects were undetectable after 19 weeks.

Types of stroke-related deficits and their impact on family caregiver's depressive symptoms, burden, and quality of life.

BACKGROUND: Stroke caregiving has been associated with higher rates of caregiver burden, depression, and lower quality of life compared to non-caregivers. Little is known about relationships between stroke survivors' Cognitive/Emotional and Motor/Functional deficits and caregivers' outcomes. OBJECTIVE: To determine the relationship between stroke survivors' Cognitive/Emotional deficits and Motor/Functional deficits and caregivers' depression, burden, and quality of life. METHOD: This is a retrospective secondary data analysis. The sample consisted of 109 caregivers of stroke survivors. Step-wise linear multiple regression analyses were conducted to determine if Cognitive/Emotional deficits and/or Motor/Functional deficits, were predictive of caregivers' depressive symptoms, burden, physical quality of life, and mental quality of life. RESULTS: The Cognitive/Emotional deficits category was a better predictor than the Motor/Functional deficit of caregivers' depressive symptoms, burden, and mental quality of life. The Cognitive/Emotional deficit score positively predicted both depression (ß = .49, p < .001) and burden (ß = 0.39, p < .001) and negatively predicted mental quality of life (ß = -0.42, p < .001), though it did not significantly predict physical quality of life (ß = -0.01, p = .90). The motor/functional deficits failed to significantly predict any of the caregiver outcomes (all p-values >.05). CONCLUSIONS: The Cognitive/Emotional deficits appear to impact caregiver well-being more than the Motor/Functional deficits. Understanding the impact of Cognitive/Emotional and Motor/Functional deficits on caregivers can help clinicians identify caregivers at the highest risk for negative outcomes.

Feasibility and acceptability of a telephone and web-based stroke caregiver intervention: a pilot randomized controlled trial of the RESCUE intervention.

OBJECTIVE: Assess the feasibility and acceptability of an Internet and telephone support and problem-solving intervention for stroke caregivers. DESIGN: Randomized controlled pilot trial with four arms: four-week intervention (n = 13), eight-week intervention (n = 13), eight-week attention control (n = 13), and standard care (n = 14). SETTING: Southeastern U.S. Veterans Health System. PARTICIPANTS: Informal caregivers of Veterans who suffered a stroke in the preceding 2.5 years were enrolled over an 18-month period. INTERVENTIONS: Intervention participants received RESCUE, a support and problem-solving intervention delivered via telephone and Internet by registered nurses. Attention control participants received active listening with no advice delivered by nurses via telephone. MAIN MEASURES: Feasibility of a larger trial was assessed via recruitment and retention. Acceptability was assessed using an adapted enactment tool and qualitative interviews. Changes in caregiver depressive symptoms and burden were measured by the Center for Epidemiologic Studies Depression Scale and Zarit Burden Interview. The study was not powered for significance testing. RESULTS: Of 340 eligible caregivers, 53 (16%) agreed to participate. Among those enrolled, 51 (96%) completed the study. Caregiver mean age was 60.3 (10.1), 49 (93%) were female and 36 (68%) were white. At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden. Acceptability and enactment tool findings indicated positive participant responses to the intervention. Most rated the amount of sessions the "right amount". Qualitative analysis revealed the intervention was valued by and acceptable to caregivers. CONCLUSIONS: Findings indicate the RESCUE intervention is feasible and acceptable to caregivers and warrants further testing.

Postdischarge Intervention for Stroke Caregivers: Protocol for a Randomized Controlled Trial.

BACKGROUND: The majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically. OBJECTIVE: The aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient's transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions. METHODS: The design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers' Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers' burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors' functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel. RESULTS: Study enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021. CONCLUSIONS: This is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke. TRIAL REGISTRATION: ClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21799.

A commentary on methodological issues in stroke caregiver research: lessons learned from three RESCUE intervention studies.

Stroke caregivers represent a distinct population and require unique considerations when conducting intervention research. Unfortunately, there are few published recommendations for conducting intervention trials with stroke caregivers. Thus, the goal of this paper is to provide foundational guidance for stroke caregiving researchers. We describe lessons learned from three trials of the RESCUE intervention to illustrate methodological issues in stroke caregiver research. We identify challenges encountered while conducting a clinical demonstration project, pilot study, and multi-site randomized controlled trial of a problem-solving and skills-building stroke caregiver intervention. We use our research experiences to exemplify or enhance understanding of each issue and describe the strategies we employed to overcome these obstacles. We present issues related to and recommendations for study design, theoretical frameworks, eligibility criteria, recruitment and retention, human subjects protection, intervention design, treatment fidelity, outcome measures, and qualitative methods. Identifying approaches to circumvent methodological challenges can help advance research on and implementation of stroke caregiver programs.