NCT02398409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

3.7 years

First QC Date

February 26, 2015

Results QC Date

February 12, 2020

Last Update Submit

June 3, 2020

Conditions

StrokeTraumatic Brain Injury

Keywords

strokeInjury, Brain, TraumaticFamily CaregiversTBI (Traumatic Brain Injury)Informal Caregivers

Outcome Measures

Primary Outcomes (4)

  • Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale

    Depression scores are measured with the PHQ9 scale. Scores can range from 0 to 27, with higher scores indicating higher levels of depression.

    Baseline, Week 12, 6 months and 1 year

  • Mediators of Caregiver's Task Difficulty

    Task difficulty is measured with the Oberst Caregiving Burden Scale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating higher levels of burden.

    Baseline, Week 12, 6 months and 1 year

  • Mediators of Caregiver's Optimism Scale

    Optimism is measured with the Life Orientation Test-Revised Scale. Scores can range from 0 to 40 with higher scores indicating more optimism.

    Baseline, Week 12, 6 months and 1 year

  • Mediators of Caregiver's Threat Appraisal Scale

    Threat appraisal is measured with the Appraisal of Caregiving Scale: Threat Subscale. Scores on a Likert scale can range from 1 to 5 with higher scores indicating less belief, feelings and ability to take care of a loved one with stroke or brain injury in the future.

    Baseline, Week 12, 6 months and 1 year

Study Arms (2)

ANSWERS-VA

EXPERIMENTAL

8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS)

Behavioral: ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths

Control

OTHER

8 week telephone usual care with education with nurse case manager

Other: Control

Interventions

ANSWERS - Acquiring New Skills While Enhancing Remaining StrengthsBEHAVIORAL

Randomized trial to evaluate the efficacy of the telephone intervention "Acquiring New Skills While Enhancing Remaining Strengths"in informal caregivers of Veterans with stroke and TBI.

ANSWERS-VA
ControlOTHER

8 week telephone usual care with education with nurse case manager

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 34813082DERIVED

MeSH Terms

Conditions

StrokeBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Virginia (Daggett) Wilder
Organization
VHA
virginia.wilder@va.gov
307-675-3659

Study Officials

  • Virginia (Ginger) S. Wilder, PhD MSN RN

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 25, 2015

Study Start

November 3, 2014

Primary Completion

June 30, 2018

Study Completion

March 31, 2019

Last Updated

June 17, 2020

Results First Posted

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)