Telephone Assessment and Skill-Building Kit (TASK): A New Program for Family Caregivers of Stroke Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00264745|
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : January 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Family Caregivers of Stroke Survivors Stroke||Behavioral: TASK intervention Behavioral: Attention Control||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Caregiver Telephone Assessment and Skill-Building Kit|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
Behavioral: TASK intervention
The Telephone Assessment and Skill-building Kit (TASK) is an individualized 8-week intervention program geared toward reducing depression and improving general health in stroke caregivers.
|Active Comparator: 2||
Behavioral: Attention Control
Minimal intervention beyond initial hospital visit.
- To determine how useful the TASK program is for family caregivers; and to compare how difficult the caregiving tasks are for the caregivers, whether they feel depressed, and how they see their own health. [ Time Frame: baseline (within 2 months after the survivors discharge home), 4 weeks (half way through intervention), 8 weeks (end of intervention), 12 weeks. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264745
|United States, Indiana|
|Indiana University School of Nursing|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Tamilyn Bakas, RN, DNS||Indiana University School of Medicine|