An interventional study of Telephone Assessment and Skill-Building Kit (TASK III) Group and Information Support and Referral (ISR) Group in Family Caregivers and Stroke, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Supportive care
Caring for a family member after a stroke can be very difficult and worsen the physical and mental health of untrained caregivers. The Telephone Assessment and Skill-Building Kit (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 themselves. The long-term goal of this study is to offer training and support for family caregivers through an efficacious, cost-effective program.
Stroke is a leading cause of serious, long-term disability, and has a very sudden onset; families are often thrust into providing care without any training from health care providers. Studies have shown that caregiving without training can be detrimental to caregiver's physical and mental health, which can impede survivor rehabilitation and lead to institutionalization and higher societal costs. Unlike existing stroke caregiver interventions that require costly face to face interactions, and that focus primarily on the survivor's care, the Telephone Assessment and Skill-Building Kit (TASK II) is delivered completely by telephone, and empowers caregivers to address both their own and the survivor's needs using innovative skill-building strategies. Aligned with current patient and caregiver guidelines, TASK II has demonstrated evidence of content validity, treatment fidelity, caregiver satisfaction, and efficacy for reducing depressive symptoms; however, future development of TASK II requires a stronger focus on self-management strategies to improve caregiver health, and enhanced use of other telehealth modes of delivery prior to implementation into ongoing stroke systems of care. The purpose of this study is to optimize the TASK III intervention through the innovative leveraging of technologies and theoretically-based self-management strategies to improve caregiver health. Specific Aim 1 consists of focus groups and individual interviews with 40 experts (10 interdisciplinary researchers, 10 technology experts, 10 clinicians and clinical leaders, and 10 stroke family caregivers) to provide preferences about essential areas of new self-management content, proposed technologies (e.g., iBook, eBook, interactive website, FaceTime, Zoom), and future implementation strategies to inform a novel TASK III prototype. Specific Aim 2 will determine feasibility of the TASK III intervention with a pilot study of 74 stroke caregivers randomized to TASK III or an Information, Support, and Referral (ISR) group in preparation for a larger randomized controlled clinical trial. Recruitment, retention, treatment fidelity, satisfaction, and technology ratings will be obtained for both TASK III and ISR groups who will receive 8 weekly sessions with a booster session 4 weeks later. Outcome measures will be explored at baseline, 8 weeks (end of intervention), and 12 weeks (after booster). If TASK III is shown to be efficacious in a future randomized controlled clinical trial, our next goal will be to translate TASK III into ongoing stroke systems of care; and, someday to adapt it for use among caregivers with other debilitating/chronic conditions providing a tremendous public health impact.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 74 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Excluded if the survivor:
Excluded if the caregiver:
Excluded if the caregiver or survivor is:
The Telephone Assessment and Skill-Building Kit (TASK III) group
Behavioral: Telephone Assessment and Skill-Building Kit (TASK III) Group
The Information, Support, and Referral (ISR) group
Behavioral: Information Support and Referral (ISR) Group
The TASK III group will receive a TASK III Resource Guide that we developed and 8 weekly calls from a nurse. The nurse will call again a month later. The TASK III nurse will help you assess your needs and concerns, build your skills as a caregiver, and refer you to community resources.
The ISR group will receive an American Heart Association brochure and 8 weekly calls from a nurse. The nurse will call again a month later. The ISR nurse will provide information, support, and referral to community resources.
Caregiver Satisfaction Ratings for Both TASK III and ISR Programs Measured by the Caregiver Satisfaction Scale (CSS).
Caregiver satisfaction ratings (usability, ease of use, acceptability) for both TASK III and ISR programs are measured using the Caregiver Satisfaction Scale (CSS). The CSS consists of 9 items rated on a response scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. Items are summed for a total score, then divided by 9 (number of items) with a possible range of 1 to 5. Higher scores indicate greater satisfaction.
Time frame: 12 weeks
Depressive Symptoms Measured by the Patient Health Questionnaire Depression Scale (PHQ-9).
Caregiver depressive symptoms are measured by the Patient Health Questionnaire Depression Scale (PHQ-9) consisting of 9 items rated on a response scale ranging from 0 = Not at all to 3 = Nearly every day. Items are summed for a total score with a possible range of 0 to 27. Higher scores indicate higher depressive symptoms.
Time frame: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
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).
Caregiver life changes (i.e., changes in social functioning, subjective well-being, and physical health as a result of providing care) are 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.
Time frame: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
Unhealthy Days Measured by the Number of Unhealthy Days in the Past 30 Days.
Caregiver unhealthy days are measured using the Unhealthy Days (UD) measure consisting of two items: How many days during the past 30 days was your physical health not good?; How many days during the past 30 days was your mental health not good? These items range from 0 = no unhealthy days to 30 = 30 unhealthy days. The two items are summed for a total score, with a cap of 30 days. Higher scores indicate more unhealthy days in the past 30 days.
Time frame: Assessed at Baseline, Week 8, and Week 12, change from Baseline to Week 8 Reported.
| Milestone | TASK III Group | ISR Group |
|---|---|---|
| Started | 36 | 38 |
| Completed | 31 | 34 |
| Not completed | 5 | 4 |
Caregiver satisfaction ratings (usability, ease of use, acceptability) for both TASK III and ISR programs are measured using the Caregiver Satisfaction Scale (CSS). The CSS consists of 9 items rated on a response scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. Items are summed for a total score, then divided by 9 (number of items) with a possible range of 1 to 5. Higher scores indicate greater satisfaction.
| score on a scale | TASK III Group | ISR Group |
|---|---|---|
| Caregiver Satisfaction Ratings for Both TASK III and ISR Programs Measured by the Caregiver Satisfaction Scale (CSS). | 4.59 ± .47 | 4.15 ± .59 |
Caregiver depressive symptoms are measured by the Patient Health Questionnaire Depression Scale (PHQ-9) consisting of 9 items rated on a response scale ranging from 0 = Not at all to 3 = Nearly every day. Items are summed for a total score with a possible range of 0 to 27. Higher scores indicate higher depressive symptoms.
| units on a scale | TASK III Group | ISR Group |
|---|---|---|
| Depressive Symptoms Measured by the Patient Health Questionnaire Depression Scale (PHQ-9). | -2.3 ± 0.7 | -0.6 ± 0.7 |
Caregiver life changes (i.e., changes in social functioning, subjective well-being, and physical health as a result of providing care) are 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.
| units on a scale | TASK III Group | ISR Group |
|---|---|---|
| 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). | 11.2 ± 2.6 | 3.1 ± 2.4 |
Caregiver unhealthy days are measured using the Unhealthy Days (UD) measure consisting of two items: How many days during the past 30 days was your physical health not good?; How many days during the past 30 days was your mental health not good? These items range from 0 = no unhealthy days to 30 = 30 unhealthy days. The two items are summed for a total score, with a cap of 30 days. Higher scores indicate more unhealthy days in the past 30 days.
| Days | TASK III Group | ISR Group |
|---|---|---|
| Unhealthy Days Measured by the Number of Unhealthy Days in the Past 30 Days. | 1.93 ± 1.70 | -1.15 ± 1.72 |
Collected over From Baseline to Week 8 and Week 12.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TASK III Group | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| ISR Group | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Age, Continuous(years) | TASK III Group | ISR Group | Total |
|---|---|---|---|
| Mean | 59 ± 13 | 56 ± 17 | 57 ± 15 |
| Sex: Female, Male(Participants) | TASK III Group | ISR Group | Total |
|---|---|---|---|
| Female | 30 | 29 | 59 |
| Male | 6 | 9 | 15 |
| Ethnicity (NIH/OMB)(Participants) | TASK III Group | ISR Group | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 34 | 38 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | TASK III Group | ISR Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 9 | 19 |
| White | 25 | 27 | 52 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Patient Health Questionnaire Depression Scale (PHQ-9)(units on a scale) | TASK III Group | ISR Group | Total |
|---|---|---|---|
| Mean | 5.36 ± 6.02 | 4.95 ± 3.88 | 5.15 ± 5.01 |
| Bakas Caregiving Outcomes Scale (BCOS)(units on a scale) | TASK III Group | ISR Group | Total |
|---|---|---|---|
| Mean | 51.72 ± 9.71 | 53.71 ± 12.95 | 52.74 ± 11.45 |
| Unhealthy Days(Days) | TASK III Group | ISR Group | Total |
|---|---|---|---|
| Mean | 9.03 ± 10.57 | 9.97 ± 9.08 | 9.51 ± 9.78 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Apr 2018 to primary completion in Jun 2021, 38 months.
Results were first posted in Apr 2024, 2 years 9 months after primary completion.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 38 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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