Stroke Clinical Trial
Official title:
Caregiver Telephone Assessment and Skill-Building Kit
The purpose of this study is to test a new educational program for families taking care of persons who have had a stroke. Caregivers are asked what they think of the TASK program and how to make it better. After getting the TASK program, their ability to provide care will be compared with a group that did not receive the TASK program.
Stroke is the number one cause of long-term disability in the United States. Many people who
have had a stroke need help from family members after they go home. Taking care of a stroke
patient can be hard since they can be unable to walk, talk, see, or think clearly. Behavior
problems, changes in personality, and depression are also common. Providing care for a
family member with stroke can often lead to caregiver depression, social isolation, and
health problems. Not having caregiving skills may be one reason for these problems. Programs
are needed to help caregivers learn caregiving skills. Such skills include finding
information about stroke, dealing with the stroke patient's emotions and behaviors,
providing personal and other types of care, and taking care of oneself as a caregiver.
The National Institute of Nursing Research said that learning how to help families cope with
a relatives' chronic illness is a very important area for research. The TASK program is an
attempt to meet this need. If the TASK program appears to be helpful and usable in this
small beginning study, we will then try to test the program more completely in a much larger
research study.
The informed consent explains the purpose and procedures for the study. The purpose is to
test the TASK program in a small group of family caregivers of persons who have had a
stroke. Caregivers are assigned to either the TASK group or a second group. The TASK group
will get the TASK notebook, and the second group will get a brochure from the American
Stroke Association. Both groups will get a telephone call every week for 8 weeks from a
nurse, each lasting about 30 minutes. At the beginning and at 4, 8, and 12 weeks there will
be a longer interview lasting about an hour. Caregivers get a $20 Wal-Mart gift card for
each of the 4 interview calls. Calls are made at times that are convenient for the
caregiver. All calls are tape-recorded. No names are used on the tape recordings or on any
of the interview questionnaires. There is a very small risk that some parts of the study may
remind some caregivers of their own situations and may be stressful or upsetting. Caregivers
may choose not to answer questions or may leave the study at any time. Taking part in the
study is up to them. Benefits include getting a $20 Wal-Mart gift card after each long
interview (up to $80 in Wal-Mart gift cards for all 4 interviews). Caregivers also get free
written information about stroke and caregiving, and free calls from a nurse. Telephone
numbers are provided for questions about the study, rights as a research participant, and
who to contact for emotional distress.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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