Clinical trial NCT02398409: Informal Caregivers ANSWERS-VA
Official title: Telephone Assessment and Skill-Building Intervention for Informal Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Traumatic Brain Injury
Keywords: stroke
Injury, Brain, Traumatic
Family Caregivers
TBI (Traumatic Brain Injury)
Informal Caregivers
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-03-25
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: Background: Stroke and traumatic brain injury (TBI) are leading causes of long-term disability among Veterans and result in the need for care from informal caregivers in the home setting. There are very few evidence-based, easy-to-deliver follow-up programs to train Veterans and caregivers across multiple domains post injury. The "Acquiring New Skills While Enhancing Remaining Strengths for Veterans (ANSWERS-VA)" intervention aims to provide the Veteran and caregiver dyad with a set of practical skills that each can use in coping with and managing symptoms of a brain injury, applying a strength-based approach.

Objectives: The objectives of this study are to conduct a randomized controlled trial (RCT) to evaluate (a) the efficacy of the ANSWERS-VA dyadic intervention with Veterans who have sustained a stroke and/or TBI and their informal caregivers, and (b) estimate effect sizes for the ANSWERS-VA intervention. The ANSWERS-VA intervention will be compared with an educational intervention that will serve as an attention control group.

Specific Aim 1: To tailor the implementation of the ANSWERS-VA intervention to dyads of Veterans post stroke and/or TBI and their informal caregivers (n=10) and modify the implementation processes for the RCT.

Specific Aim 2: To test the short-term (immediately post-intervention) and long-term, sustained (12 and 24 weeks, and at 1 year) efficacy of the ANSWERS-VA intervention for improving: (a) the primary outcomes of the caregivers' quality of life and unhealthy days, and (b) the caregiver mediators of task difficulty, threat appraisal, self-efficacy for caregiving, and optimism.

Specific Aim 3: To evaluate program delivery costs for the ANSWERS-VA intervention and the educational attention control procedures, and to assess the cost-effectiveness of the ANSWERS-VA intervention in terms of noncaregiving hours and unhealthy days in caregivers of Veterans post stroke and/or TBI.

Exploratory Aim 1: To estimate the effect sizes for the ANSWERS-VA intervention for the caregiver and Veteran on the secondary outcomes of depressive symptoms, social participation, and quality of the dyadic relationship.

Methods: The investigators propose to conduct a RCT to evaluate the ANSWERS-VA intervention among Veterans with stroke or TBI and their caregivers (dyads). Veterans with stroke (N = 222) or TBI (N = 108) and their informal caregivers, who have received care at the Michael E. DeBakey Veterans Affairs Medical Center in Houston or the Richard L. Roudebush VAMC in Indianapolis, will be randomized to the ANSWERS-VA intervention or to an attention control group. Both the intervention and control procedures involve 8 telephone sessions delivered over 8 weeks, with a booster session at 12 weeks. Data collections will occur at baseline, 8 weeks (short-term intervention effect), 12 weeks (after booster), 24 weeks, and 1 year after baseline (long-term sustainability of intervention effect). Linear mixed models will be applied to the repeated-measures data to test efficacy of the program in stroke caregivers and to estimate effect sizes in TBI caregivers. An incremental cost-effectiveness ratio will be employed to address the comparative costs and outcomes for the ANSWERS-VA intervention and attention control groups.

Status: Essential modifications for this project were requested and approved via VA Central Office. Institutional Review Board approval has been obtained for these modifications in Indianapolis and in Houston. Graduate students from multiple disciplines have been hired and have received two days of onsite training specific to the ANSWERS-VA intervention and control procedures, screening, recruitment, and data collection processes. The REDCap database has been updated for the project modifications and has been further tested. The investigators are currently working with frontline providers at both sites to recruit potential participants for this RCT. Enrollment of first subject dyads began November, 2014. At this time, the investigators have completed recruitment of new dyads. We continue to complete outcomes assessments on some dyads. We plan to submit an abstract to the International Stroke Conference in January 2019.

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

Primary outcomes:
measure: Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale
timeFrame: Baseline, Week 12, 6 months and 1 year
measure: Mediators of Caregiver's Task Difficulty
timeFrame: Baseline, Week 12, 6 months and 1 year
measure: Mediators of Caregiver's Optimism Scale
timeFrame: Baseline, Week 12, 6 months and 1 year
measure: Mediators of Caregiver's Threat Appraisal Scale
timeFrame: Baseline, Week 12, 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Virginia (Ginger) S. Wilder, PhD MSN RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.