StrokeNCT02398409

Informal Caregivers ANSWERS-VA

A study testing ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths in people with Stroke and Traumatic Brain Injury, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke, Traumatic Brain Injury
What is being tested?: ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: 2 sitesUnited States
Study dates: 3 Nov 2014to 31 Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884

Other trials in United States

About this study

Official title: Telephone Assessment and Skill-Building Intervention for Informal Caregivers

Read the 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.

Conditions: Stroke, Traumatic Brain Injury
Being tested: ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths, Control
Keywords: stroke, Injury, Brain, Traumatic, Family Caregivers, TBI (Traumatic Brain Injury), Informal Caregivers
Medical subject headings: Stroke, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ANSWERS - Acquiring New Skills While Enhancing Remaining StrengthsBehavioural
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.
ControlOther
8 week telephone usual care with education with nurse case manager

Study groups in NCT02398409
Study group	Role	What they receive
ANSWERS-VA	Experimental	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) Receives: Behavioral: ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths
Control	Other	8 week telephone usual care with education with nurse case manager Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, 6 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 201431 Mar 2019

First posted25 Mar 2015 (estimated)
Study start3 Nov 2014
Primary completion30 Jun 2018
Study completion31 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02398409
Sponsor's protocol ID: NRI 12-415
Status last verified: Jun 2020
First submitted: 26 Feb 2015
Last updated: 17 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34813082

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telephone Assessment and Skill-Building Intervention for Informal Caregivers
ClinicalTrials.gov ID: NCT02398409
Acronym / sponsor ID: NRI 12-415
Conditions: Stroke, Traumatic Brain Injury
Keywords: stroke, Injury, Brain, Traumatic, Family Caregivers, TBI (Traumatic Brain Injury), Informal Caregivers
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 3 Nov 2014 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 31 Mar 2019 (actual)
First posted: 25 Mar 2015 (estimated)
Results: Posted 17 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ANSWERS-VA	Experimental	Behavioral: ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS)
Control	Other	Other: Control8 week telephone usual care with education with nurse case manager

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (16 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ANSWERS - Acquiring New Skills While Enhancing Remaining StrengthsRandomized 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.	Behavioural	ANSWERS-VA
Control8 week telephone usual care with education with nurse case manager	Other	Control

Primary outcome

Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale
Time frame: Baseline, Week 12, 6 months and 1 year
Depression scores are measured with the PHQ9 scale. Scores can range from 0 to 27, with higher scores indicating higher levels of depression.
Mediators of Caregiver's Task Difficulty
Time frame: Baseline, Week 12, 6 months and 1 year
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.
Mediators of Caregiver's Optimism Scale
Time frame: Baseline, Week 12, 6 months and 1 year
Optimism is measured with the Life Orientation Test-Revised Scale. Scores can range from 0 to 40 with higher scores indicating more optimism.
Mediators of Caregiver's Threat Appraisal Scale
Time frame: Baseline, Week 12, 6 months and 1 year
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.

Results and safety

Results posted to the registry on 17 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ANSWERS-VA	69	67
Control	68	63

Primary outcome: Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale

Time frame: Baseline, Week 12, 6 months and 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	ANSWERS-VA n = 66	Control n = 62
Baseline	.56 (.53)	.68 (.61)
Week 12	.41 (.45)	.62 (.59)
6 Months	.20 (.25)	.57 (.56)
1 Year	.47 (.66)	.43 (.49)

ANSWERS-VA: Mean Difference (Net): .016, p = .8407, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .201, p = .0150, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .114, p = .8373, Mixed Models Analysis

Population analysed: Not change data. One Intervention Caregiver and one Control Caregiver did not complete the PHQ9. Those data are missing.

Primary outcome: Mediators of Caregiver's Task Difficulty

Time frame: Baseline, Week 12, 6 months and 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	ANSWERS-VA n = 67	Control n = 63
Baseline	1.99 (.77)	1.83 (.68)
12 Week	1.73 (.70)	1.73 (.61)
6 Months	1.70 (.64)	1.63 (.57)
1 Year	1.78 (.62)	1.66 (.79)

ANSWERS-VA: Median Difference (Net): .016, p = .6445, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .033, p = .5247, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .1224, p = .9974, Mixed Models Analysis

Population analysed: Not change data

Primary outcome: Mediators of Caregiver's Optimism Scale

Time frame: Baseline, Week 12, 6 months and 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	ANSWERS-VA n = 67	Control n = 62
Baseline	2.29 (.35)	2.33 (.39)
12 Week	2.19 (.40)	2.29 (.27)
6 Months	2.31 (.34)	2.29 (.31)
1 Year	2.25 (.27)	2.28 (.37)

ANSWERS-VA: Median Difference (Net): .054, p = .1918, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .046, p = .9212, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .026, p = .2358, Mixed Models Analysis

Population analysed: Not change data. One Control Caregiver did not complete the Life Orientation Test-Revised Scale. Those data are missing.

Primary outcome: Mediators of Caregiver's Threat Appraisal Scale

Time frame: Baseline, Week 12, 6 months and 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	ANSWERS-VA n = 67	Control n = 62
Baseline	2.73 (.86)	2.66 (.78)
12 Week	2.56 (.83)	2.49 (.68)
6 Months	2.38 (.95)	2.69 (.67)
1 Year	2.58 (1.0)	2.44 (.61)

ANSWERS-VA: Median Difference (Net): .008, p = .1107, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .251, p = .0562, Mixed Models Analysis
ANSWERS-VA: Median Difference (Net): .226, p = .8579, Mixed Models Analysis

Population analysed: Not change data. One Control Caregivers did not complete the Threat Subscale. Those data are missing.

Adverse events

Time frame: Baseline to 12 month follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ANSWERS-VA	0 of 67 (0%)	2 of 67 (3%)	0 of 67
Control	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34813082Crocker 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Virginia (Ginger) S. Wilder, PhD MSN RN principal investigator

Richard L. Roudebush VA Medical Center, Indianapolis, IN

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale (time frame: Baseline, Week 12, 6 months and 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02398409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.