Stroke Clinical Trial
Official title:
Telehealth Assessment and Skill-Building Intervention for Stroke Caregivers (TASK III)
Caring for a family member after a stroke can be very difficult and worsen the physical and mental health of untrained caregivers. The TASK III intervention is a unique, comprehensive caregiver intervention program that enables caregivers to develop the necessary skills to manage care for the survivor, while also taking care of their own health.
Status | Recruiting |
Enrollment | 296 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Primary caregiver (family member or significant other providing care for a stroke survivor at home). - Fluent in the English language (i.e., able to read, speak, and understand English) - Access to telephone or computer. - No difficulties hearing or talking by telephone or computer. - Score 4 or more on a 6-item cognitive impairment screener. - Willing to participate in 9 calls from a nurse and 5 data collection interviews (Baseline, 8, 12, 24, 52). Exclusion Criteria: Excluded if the survivor: - Had not had a stroke. - Did not need help from the caregiver. - Resides in a nursing home or long-term care facility. Excluded if the caregiver or survivor is: - Under the age of 18 years. - Prisoner or on house arrest. - Pregnant. - Terminal illness (e.g., late stage cancer, end-of-life condition, renal failure requiring dialysis). - History of Alzheimer's, dementia, or severe mental illness (e.g., suicidal tendencies, schizophrenia, severe untreated depression or manic-depressive disorder). - History of hospitalization for alcohol or drug abuse within the past 5 years). |
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati College of Nursing | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Cincinnati | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mediator: Task Difficulty | Oberst Caregiving Burden Scale Difficulty Subscale (OCBS) - 15 caregiving tasks rated based on level of difficulty. The OCBS consists of 15 items rated on a response scale ranging from -3 (extremely difficult) to +3 (extremely easy). The items are recoded (-3 = 7) (-2 = 6) (-1 = 5) (0 = 4) (1 = 3) (2 = 2) (3 = 1) so that positive numbers can be obtained for analysis. The recoded responses to the 15 items are summed for a total score with a possible range of 15-105. Higher scores indicate more difficulty with caregiving tasks. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Other | Mediator: Threat Appraisal | Appraisal of Caregiving Threat Subscale (ACS) consists of 12 items rated on a scale from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate higher threat appraisal. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Other | Mediator: Self-efficacy of Exercise | The Self-Efficacy Exercise scale (SEE) consists of 10 items rated on a scale from 1 = not at all confident to 10 = extremely confident. Higher scores indicate greater self-efficacy of exercise. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Other | Mediator: Self-efficacy of Diet | The Self-Efficacy Diet scale (SED) consists of 10 items rated on a scale from 1 = not at all confident to 10 = extremely confident. Higher scores indicate greater self-efficacy of diet. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Other | Program Evaluation Outcomes: Satisfaction | Caregiver Satisfaction Scale (CSS) usefulness, ease of use, and acceptability of the TASK III and ISR interventions consisting of 9 items rated on a scale from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate more positive program outcomes. | 12 weeks | |
Other | Program Evaluation Outcomes: Technology | Caregiver Technology Evaluation Scale (CETS) consisting of 9 items rated on a scale from 1 = strongly disagree to 5 = strongly agree. Higher scores indicate more positive program outcomes. | 12 weeks | |
Primary | Life Changes | Life Changes (i.e., changes in social functioning, subjective well-being, and physical health as a result of providing care) measured by the Bakas Caregiving Outcomes Scale (BCOS). The BCOS consists of 15 items rated on a response scale ranging from -3 (changed for the worst) to +3 (Changed for the best). The items are recoded (-3 = 1) (-2 = 2) (-1 = 3) (0 = 4) (1 = 5) (2 = 6) (3 = 7) so that positive numbers can be obtained for analysis. The recoded responses to the 15 items are summed for a total score with a possible range of 15-105. Higher scores indicate more positive life changes as a result of providing care. | Baseline to 8 weeks (primary endpoint), long-term baseline to 12, 24, and 52 weeks | |
Secondary | Depressive Symptoms | Patient Health Questionnaire Depression Scale (PHQ-9) 9 items rated on a scale from 0 = not at all to 4 = nearly every day. Higher scores reflect more depressive symptoms. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Secondary | Other Symptoms | Visual numeric symptoms used in the Chronic Disease Self Management Program (CDSMP) study on a scale from 1-10 (stress, fatigue, sleep, pain, shortness of breath). Higher scores indicate higher severity of the symptom. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Secondary | Unhealthy Days | Unhealthy Days (UD), 2 items, number of days in the past 30 days that physical and mental health have not been good. Items totaled, then capped at 30 days for a total score. Analyzed at the item level as well. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Secondary | Self-management of Steps | Pedometer measuring number of steps per day. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Secondary | Self-management of Exercise | Physical Activity Scale for Elderly, PASE; consists 10 items measuring physical activity. The total PASE score is computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by the empirically derived item weights and summing over all activities. The PASE score can be stratified in tertiles: 0 to 40 (sedentary), 41 to 90 (light physical activity) and more than 90 (moderate to intense activity). | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Secondary | Self-management of Diet | Dietary Screener Questionnaire consists of 30 items measuring diet intake. Scores provide predicted intake of fruits, vegetables, added sugars, whole grains, fiber, calcium, and dairy. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) | |
Secondary | Healthcare Utilization | Self-reported past 3 months, hospitalizations, ER visits, Office visits (medical, dental, vision), immunizations, screening. | Baseline to 8 weeks (shortterm), baseline to 12, 24, and 52 weeks (long-term) |
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