N/A
N=137
Informal Caregivers ANSWERS-VA
Stroke · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02398409 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale — .56; .68; .41; .62 score on a scale — p=.8407
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths (Behavioral); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale |
.56; .68; .41; .62; .20; .57 | .8407 |
| PRIMARY Mediators of Caregiver's Task Difficulty |
1.99; 1.83; 1.73; 1.73; 1.70; 1.63 | .6445 |
| PRIMARY Mediators of Caregiver's Optimism Scale |
2.29; 2.33; 2.19; 2.29; 2.31; 2.29 | .1918 |
| PRIMARY Mediators of Caregiver's Threat Appraisal Scale |
2.73; 2.66; 2.56; 2.49; 2.38; 2.69 | .1107 |
Summary
The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also determining it's cost effectiveness in the stroke and traumatic brain injury (TBI) populations.
Eligibility Criteria
Inclusion Criteria
- Informal caregiver of a family member or friend (Veteran) with a stroke or TBI
- Caregiver must express need or concerns in providing care
- Plans to be providing care for 1 year or longer
- Access to telephone
- Willingness to participate in 9 call from a nurse and 5 data collection calls at designated timepoints
- Veteran's stroke must be within past 3 years
- Veteran's TBI must be since 9/11/01
Exclusion Criteria
- Caregiver or survivor age < 18 years
- Caregiver denies that survivor has had a stroke or a TBI
- Caregiver does not consider him or herself a caregiver, stating that the survivor is not impaired or is the same as before the stroke or TBI
- 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 with serious medical illness limiting ability to participate
- Caregiver refuses to sign a HIPAA authorization allowing the VA to store personal health information (PHI) in a location outside the VA
- 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 Alzheimer's, dementia, suicidal tendencies, severe untreated depression or manic depressive disorder, or schizophrenia.
- Survivor or caregiver pregnancy
- Survivor or caregiver is a prisoner or on house arrest
- Survivor had a Transient Ischemic Attack (rather than a hemorrhagic or ischemic stroke)
- Survivor had a stroke more than 3 years ago
Data sourced from ClinicalTrials.gov (NCT02398409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.