TASKII: Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

Sponsor

Indiana University (Other)

Overall Status

Completed

CT.gov ID

NCT01275495

Collaborator

National Institute of Nursing Research (NINR) (NIH)

254

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II) compared with an Information, Support, and Referral (ISR) intervention in family caregivers of stroke survivors. We will also test if TASK II intervention effects on primary outcomes (depressive symptoms, caregiving-related negative life changes, unhealthy days) are mediated through effects on secondary outcomes (task difficulty, optimism, threat appraisal). Comparative costs and outcomes for the TASK II and ISR interventions will also be explored.

Condition or Disease	Intervention/Treatment	Phase
Stroke Family Caregivers	Behavioral: Telephone Assessment and Skill-Building Kit (TASK II) Behavioral: Information, Support, and Referral (ISR)	Phase 3

Detailed Description

Stroke is the number one cause of disability in the United States, and over 4 million stroke survivors are alive today. Many stroke survivors need the help of a family caregiver. A family caregiver is a family member or close friend who helps the stroke survivor once they go home. Many caregivers need information and support during the first few months after the stroke survivor is discharged home. One group of caregivers will receive the TASK II intervention and another group of caregivers will receive existing educational materials about stroke and caregiving through an information, support, and referral (ISR) process. Both groups of caregivers will receive written materials about stroke and caregiving by mail and weekly telephone calls by a nurse for a total of 8 weeks, with an additional call at 12 weeks. A research assistant will also call by telephone at the beginning of the study, and at 8, 12, and 24 weeks after the beginning of the study, with a follow-up call at 1 year to interview both groups of caregivers about their caregiving activities and about their own health and well-being. If shown to be efficacious, our next goal will be to translate the TASK II intervention into practice settings to meet current recommendations and guidelines that emphasize follow up care for stroke survivors and their family caregivers.

Study Design

Study Type:

Interventional

Actual Enrollment :

254 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Telephone Assessment and Skill-Building Intervention for Stroke Caregivers

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telephone Assessment and Skill-Building Kit (TASK II) The TASK II group will fill out a checklist about their needs and concerns, and will receive written tip sheets by mail that address the needs and concerns that they feel are most important. A nurse will call by telephone (lasting about 30 minutes or less) once a week for a total of 8 weeks, with another call at 12 weeks, to provide more information, answer questions, and to discuss more written tip sheets based on the caregiver's needs and concerns.	Behavioral: Telephone Assessment and Skill-Building Kit (TASK II)
Active Comparator: Information, Support, and Referral (ISR) The ISR group will receive existing educational materials about stroke and caregiving developed by the American Stroke Association and weekly telephone calls by a nurse (lasting about 30 minutes or less) for a total of 8 weeks, with another call at 12 weeks.	Behavioral: Information, Support, and Referral (ISR)

Arm

Intervention/Treatment

Experimental: Telephone Assessment and Skill-Building Kit (TASK II)

The TASK II group will fill out a checklist about their needs and concerns, and will receive written tip sheets by mail that address the needs and concerns that they feel are most important. A nurse will call by telephone (lasting about 30 minutes or less) once a week for a total of 8 weeks, with another call at 12 weeks, to provide more information, answer questions, and to discuss more written tip sheets based on the caregiver's needs and concerns.

Behavioral: Telephone Assessment and Skill-Building Kit (TASK II)

Active Comparator: Information, Support, and Referral (ISR)

The ISR group will receive existing educational materials about stroke and caregiving developed by the American Stroke Association and weekly telephone calls by a nurse (lasting about 30 minutes or less) for a total of 8 weeks, with another call at 12 weeks.

Behavioral: Information, Support, and Referral (ISR)

Outcome Measures

Primary Outcome Measures

Depressive symptoms: Patient Health Questionnaire Depression Scale (PHQ-9) [Change in depressive symptoms from baseline to 8 weeks]
Among caregivers who screen positive for depressive symptoms at baseline, those randomized to the TASK II intervention will have a greater reduction in depressive symptoms compared to those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Caregiving-related negative life changes: Bakas Caregiving Outcomes Scale (BCOS) [Change in caregiving-related negative life changes from baseline to 8 weeks]
Caregivers randomized to the TASK II group will have a greater reduction in caregiving-related negative life changes compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Unhealthy days: Unhealthy Days (UD) [Change in unhealthy days from baseline to 8 weeks]
Caregivers randomized to the TASK II group will have a greater reduction in unhealthy days compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.

Secondary Outcome Measures

Task difficulty: Oberst Caregiving Burden Scale Difficulty Subscale (OCBS) [Change in task difficulty from baseline to 8 weeks]
Caregivers randomized to the TASK II group will have a greater reduction in task difficulty compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Optimism: Revised Life Orientation Test (LOT-R) [Change in optimism from baseline to 8 weeks]
Caregivers randomized to the TASK II group will have a greater increase in optimism compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.
Threat appraisal: Appraisal of Caregiving Threat Subscale (ACS) [Change in threat appraisal from baseline to 8 weeks]
Caregivers randomized to the TASK II group will have a greater reduction in threat appraisal compared with those randomized to the ISR group from baseline to 8 weeks, after controlling for selected covariates. Long-term, sustained efficacy will be assessed at 12 and 24 weeks, and at 1 year.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Primary caregiver (unpaid family member or significant other) of a stroke survivor
No more than 8 weeks after survivor discharged home
Plans to be providing care for 1 year or longer
Access to a telephone
Willingness to participate in 9 calls from a nurse and 5 data collection interviews at designated study time points

Exclusion Criteria:

Caregiver or survivor age < 21 years
Caregiver denies that survivor has had a stroke
Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke
Caregiver has low task difficulty (OCBS task difficulty score < 16)
Caregiver communication difficulties (e.g., hearing loss)
Caregiver not fluent in the English language
Caregiver 6-item MMSE score less than 4
Survivor residing in a nursing home or long-term care facility
Survivor or caregiver has a terminal illness (e.g., cancer, end of life condition with decreased life expectancy, renal failure requiring dialysis)
Survivor or caregiver history of hospitalization for alcohol or drug abuse
Survivor or caregiver history of severe mental illness (e.g., Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, schizophrenia)
Survivor or caregiver pregnancy
Survivor or caregiver is a prisoner or on house arrest