NCT Number: NCT03142841
This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.
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VA Caribbean Healthcare System, San Juan, PR, San Juan, Puerto Rico
This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.
The investigators will conduct a two-arm (8-session intervention vs. standard care), , randomized controlled trial to test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. A sample of 290 stroke caregivers will be randomly assigned to either an intervention or a standard care group. Eligibility criteria: Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group. We will determine caregiver status.
Baseline measurements will be conducted with the caregivers prior to the intervention. Post-test assessments will be collected at 1 and 12 weeks post-intervention. In addition, the investigators will obtain pre- and post-test measures of Veteran-related variables via Computerized Patient Record System (CPRS) electronic health records. Qualitative interviews will be conducted to assess caregivers' perceptions of the intervention. A general linear mixed model for repeated measures will be used to examine the relationship between treatment assignment and each outcome over time. The investigators will measure the budgetary impact of providing intervention by comparing the costs of the intervention group to the costs of the control group.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group.
Random assignment to the intervention or standard care group. The investigators will determine caregiver status.
Exclusion criteria
The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria or are managing end-of-life issues (stroke survivors are likely to die within five months following discharge).
The RESCUE Problem Solving Intervention: This is an education and support intervention for caregivers of Veterans with stroke. The investigators taught study participants the COPE (Creativity, Optimism, Planning, Expert Advice) model of problem solving and guided them through the application of this model in their caregiver role. They also receive tailored stroke education, specific to their needs.
Time frame: 9 weeks after baseline
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
Time frame: 21 weeks after baseline
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
Time frame: 9 weeks
Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.
Time frame: 21 weeks
Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.
Time frame: 9 weeks
Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 21 weeks
Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 9 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 21 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 9 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 21 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
Time frame: 9 weeks
Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes.
Time frame: 21 weeks
Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes.
Time frame: 9 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 21 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 9 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 21 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
Time frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
Time frame: 9 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 21 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 9 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 21 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 9 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
Time frame: 21 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
VA Office of Research and Development
Fed
Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke
Acronym: RESCUE
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