Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial

A prospective randomized controlled clinical trial design, with outcome data collectors blinded to treatment assignment, was used to evaluate the efficacy of the revised TASK II relative to an information, support, and referral (ISR) comparison group. Both the groups received written materials, 8 weekly calls from a nurse, and a booster session 1 month later. The study was approved by the Indiana University Office of Research Compliance Human Subjects Office (Institutional Review Board) for protection of human subjects and by each facility where recruitment occurred. Recruitment occurred May 1, 2011 through October 7, 2013. Enrolled subjects gave informed consent.

The primary aim was to examine the short-term (immediately postintervention at 8 weeks) and long-term, sustained (12, 24, and 52 weeks) efficacy of the TASK II intervention relative to the ISR comparison group for improving caregivers’ depressive symptoms, caregiving-related life changes, and UD. For depressive symptoms, primary analyses were performed for the subgroup with mild to severe depressive symptoms at baseline; secondary analyses for depressive symptoms used the entire cohort. Selected covariates were included in the analyses to adjust for group differences in potential confounders.

A total of 254 stroke family caregivers were randomized either to the TASK II group (n=123) or to the ISR comparison group (n=131). Family caregivers were recruited from 2 rehabilitation hospitals and 6 acute care hospitals in the Midwest. Participants were screened within 8 weeks after the survivor was discharged home. Caregivers were included if the following criteria were met: was the primary caregiver (unpaid family member or significant other), 21 or more years of age, fluent in the English language, had access to a telephone, had no difficulties hearing or talking on the telephone, planned to be providing care for ≥1 year, and were willing to participate in 9 calls from a nurse, and 5 data collection interviews. Caregivers were excluded if: the patient had not had a stroke, did not need help from the caregiver, or was going to reside in a nursing home or long-term care facility; the caregiver scored <16 on the Oberst Caregiving Burden Scale Task Difficulty Subscale²⁴ or <4 on a 6-item cognitive impairment screener.²⁵ In addition, caregivers and stroke survivors were excluded if either was pregnant; a prisoner or on house arrest; had a terminal illness (eg, cancer, end-of-life condition, and renal failure requiring dialysis); had a history of Alzheimer, dementia, or severe mental illness (eg, suicidal tendencies, severe untreated depression or manic depressive disorder, and schizophrenia); or had been hospitalized for alcohol or drug abuse.

The participant flow diagram is provided in Figure 1. Of the 2742 stroke caregivers assessed for eligibility, 254 were randomized to the TASK II intervention (n=123) or to the ISR comparison group (n=131). The refusal rate was minimal at 17.1%; 29.8% caregivers were unable to contact; and 43.8% were ineligible, primarily because the survivor did not need help from a family caregiver, or the survivor was residing in a nursing home or long-term care facility. Attrition rates ranged from 8.1% at 8 weeks to 32.5% at 52 weeks for the TASK II group and 8.4% at 8 weeks to 29.0% at 52 weeks for the ISR group. The sample size was determined based on pilot data anticipating a 10% attrition rate for the 8-week time point for the primary outcomes, using power estimates. Given the full sample of 100 subjects per group, a 0.20 effect size provided a power of 0.81 to detect the treatment by time interactions. Given the 10% attrition rate, a sample of 220 caregivers would be needed. To complete those being assessed for eligibility, enrollment exceeded the projected 220 caregivers by an additional 34 caregivers (total, 254 caregivers). On the basis of pilot data of 38% screening positive for depressive symptoms (PHQ-9 ≥5), it was estimated that there would be a total of 76 caregivers (38 per group), which would provide a power of 0.81 to detect an effect size of 0.33 for the treatment by time interaction using a 5% type I error rate. The sample consisted of a total of 111 caregivers (49 TASK II and 62 ISR) who screened positive for depressive symptoms.

Study data were collected and managed using REDCap electronic data capture tools hosted at Indiana University.³⁹ All analyses were conducted using SAS version 9.4.³⁸ Baseline equivalence in demographic characteristics and outcome measures between TASK II and ISR groups was tested using independent samples t (continuous variables) or χ² (categorical variables). Variables with significant differences between the 2 groups were selected as covariates. Using an intent-to-treat approach, dependent variables consisting of change relative to baseline value for depressive symptoms, life changes, and UD were entered into general linear models.⁴⁰ These models incorporated covariates and took into account the correlation among repeated measures on the same individual.⁴¹

At baseline, 47.2% of caregivers in the TASK II group and 50.4% in the ISR group reported mild to severe depressive symptoms (PHQ-9 ≥5; Table 3). Among these caregivers, those in the TASK II group reported a greater reduction in depressive symptoms from baseline to 8 weeks than those in the ISR group (mean difference [SE]=−2.6 [1.1]; P=0.013; Table 4). This represented a statistically significant interaction between time and treatment. Secondary analyses for depressive symptoms were not significant using the total sample. Groups were similar from baseline to 8 weeks for life changes. Caregivers in the TASK II group reported a greater reduction in UD from baseline to 8 weeks than those in the ISR group (mean difference [SE]=−2.9 [1.3]; P=0.025; Table 4). Caregivers within the TASK II group reported improvements in depressive symptoms in both the subgroup (P<0.001) and the entire cohort (P<0.05) and life changes (P<0.05) from baseline to 8 weeks (Table 4).

Similar to results at the primary end point, caregivers with PHQ-9 ≥5 in the TASK II group reported a greater reduction in depressive symptoms than those in the ISR group from baseline to 24 weeks (mean difference [SE]=−1.9 [0.09]; P=0.041) and from baseline to 52 weeks (mean difference [SE]=−3.0 [1.1]; P=0.008); although these results were not significant using the entire cohort (Table 4). Although life changes were similar for the full sample from baseline to 12 weeks (P=0.178; Table 4), for caregivers with PHQ-9 ≥5 at baseline, TASK II participants had greater improvement in life changes than ISR participants from baseline to 12 weeks (mean difference [SE]=5.8 [2.9]; P=0.046). Moreover, caregivers within the TASK II group reported improvements in depressive symptoms for the PHQ-9 ≥5 subgroup (P<0.001) and the entire cohort (P<0.05) and life changes (P<0.05) from baseline to 12, 24, and 52 weeks (Table 4). Caregivers within the ISR group reported improvement in depressive symptoms in the PHQ ≥5 subgroup from baseline to 12 and 24 weeks (P<0.01; Table 4).

Nevertheless, the TASK II program for family caregivers of stroke survivors postdischarge successfully reduced depressive symptoms within a subgroup experiencing mild to severe depressive symptoms compared with those in the ISR group. These results were evident at our primary end point of 8 weeks and were sustained at both 24 and 52 weeks. Although other stroke caregiver intervention studies have reported improvements in caregiver depressive symptoms,²⁰ only one study reported sustainability at 52 weeks.⁴² The study by Kalra et al⁴² was a well-designed, randomized controlled clinical trial that tested the efficacy of a hands-on caregiver training program in a sample of 300 stroke caregivers. The intervention group received 3 to 5 inpatient sessions and 1 home visit focused on a variety of skills that included goal setting and tailored psychoeducation, although tailoring of the intervention was based on the needs of the stroke survivor rather than the caregiver. The TASK II intervention is unique in that it is delivered completely by telephone, trains caregivers how to assess and address their own needs, and is applicable to a wide variety of stroke caregivers (eg, spouses, adult children, and others). Screening for and addressing caregiver depressive symptoms, as in the TASK II program, not only have the potential to improve caregiver outcomes,^10,12,19,20 but may improve the survivors’ recovery¹⁵ and reduce the potential for their long-term institutionalization.^9,17,18

At 8, 12, 24, and 52 weeks, the TASK II intervention did not significantly affect life changes for the total sample. However, the TASK II program improved caregiver life changes in caregivers with mild to severe depressive symptoms compared with those randomized to the ISR group at 12 weeks. Although life changes were similar for both TASK II and ISR groups across the total sample, it is possible that caregivers with some depressive symptoms experienced more life changes as a result of providing care. Life changes and depressive symptoms have been found to be correlated.^10–12 Improvement in life changes in caregivers with some depressive symptoms builds on our previous work with the original TASK intervention, which had little effect on life changes.³³ For the TASK II intervention, we incorporated the BCOS into the intervention during the fifth call with the nurse as an additional assessment, encouraging caregivers to select priority needs that were targeted toward improving their own personal life changes. Further refinement of the TASK II intervention may be to use the BCOS earlier, (eg, second or third call) to allow caregivers more time to address their own life changes. Only one other intervention study has reported life changes as an outcome in stroke caregivers.⁴³ King et al⁴³ found that life changes improved for a group of caregivers who received a problem-solving intervention immediately postintervention; however, results were not sustained at 6 months or 1 year, and there were high attrition rates. Generalizability was limited to spousal caregivers. Other intervention studies have measured similar quality of life concepts with mixed results.²⁰ Caregivers commonly experience adverse life changes because they neglect their own needs while providing care, and they often need encouragement to care for themselves.^{2,3,10–12,36} The TASK II intervention encourages caregivers to attend the needs of the survivor and their own changes in social functioning, subjective well-being, and physical health.

Most notably, UD were reduced for the caregivers in the TASK II group compared with those randomized to the ISR group at our primary end point of 8 weeks. A trend toward fewer UD was noted for the TASK II group at 12, 24, and 52 weeks (Figure 2). Future enhancements of the TASK II program may be warranted to include a stronger focus on referring caregivers to healthcare providers to address their own physical and mental health needs. Addressing health conditions as well as preventive healthcare measures is important for both stroke survivors and family caregivers. The stroke family caregiver intervention literature is limited with regard to caregiver health²⁰; only 2 studies found improvement in general health of the caregiver.^43,44 Other studies had nonsignificant findings using the SF-36 general health subscale.^33,45 TASK II intervention having a significant impact on a global measure of UD²⁷ underscores the strength of the TASK II intervention and its potential to improve population health in general for family caregivers.

The study used a convenience sample of stroke caregivers recruited from acute care and inpatient rehabilitation settings in the Midwest where most of the participants were white and Non-Hispanic. Caregivers were recruited within 8 weeks of the survivor’s discharge to home, making findings less generalizable to long-term caregivers. Caregivers were older (mean age, 54–55 years), making findings less applicable to younger caregivers who were also parents of young children. Survivor characteristics were collected by caregiver proxy. Future studies should incorporate more objective data from medical records or directly from the stroke survivors themselves. Finally, there were group differences in protocol adherence, time spent reading materials, and longer call time; although, longer call time with the nurses was used as a covariate in the analyses. Although overall adherence for the TASK II group was 80% and the ISR group was 92%, the checklist for the TASK II group included additional items specific to the TASK II intervention that were repetitive and not needed during every call. Comparison with adherence percentages for shared items on the checklist was 90% for the TASK II group and 92% for the ISR group.³⁵

Despite these limitations, the TASK II intervention is useful. It includes a close connection with current scientific and practice guidelines that recommend assessment of caregiver needs and concerns, as well as the use of a combination of psychoeducational and skill-building strategies.^19–22 Training caregivers to assess their own needs and concerns and to address those using individualized skill-building strategies provides a caregiver-driven approach to self-care. The TASK II intervention is unique among intervention studies²⁰ because it is delivered completely by telephone, making it accessible to caregivers in both rural and urban home settings.^32,33,35 Key attributes of the nurses delivering the intervention included the hiring of qualified, engaged nurses who had a registered nurses licence.³⁵ Education level did not matter as much as the quality of communication skills and the ability to follow the caregiver’s lead.³⁵ Nurses commented on how telephone delivery sharpened their listening skills,³⁵ similar to findings from another study in which telephone delivery allowed interveners to develop enhanced listening skills to compensate for the absence of visual cues.⁴⁶ Future development of the intervention may involve enhanced use of other telehealth modes of delivery, such as video, web-based, and remote monitoring technologies.⁴⁷ The TASK II intervention has a documented track record of treatment fidelity, including structured protocols for nurse training.³⁵ The challenge is how to implement the program into stroke systems of care. Future research is needed to enhance the TASK II program using innovative telehealth technologies and to implement the TASK II program into ongoing systems of stroke care.