Informal Caregivers ANSWERS-VA

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02398409
• Collaborator: (none)
• Enrollment: 143
• Locations: 2
• Arms: 2
• Actual Duration (Months): 52.9
• Patients Per Site: 71.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Traumatic Brain Injury	Behavioral: ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths; Other: Control	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Telephone Assessment and Skill-Building Intervention for Informal Caregivers
• Actual Study Start Date: Nov 3, 2014
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ANSWERS-VA 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; 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.
Other: Control 8 week telephone usual care with education with nurse case manager	Other: Control; 8 week telephone usual care with education with nurse case manager

Outcome Measures

Primary Outcome Measures

1. Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale [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.

2. Mediators of Caregiver's Task Difficulty [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.

3. Mediators of Caregiver's Optimism Scale [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.

4. Mediators of Caregiver's Threat Appraisal Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana	United States	46202-2884
2	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas	United States	77030

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Virginia (Ginger) S. Wilder, PhD MSN RN, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 15, 2015
• Informed Consent Form - Mar 24, 2016

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02398409
• Other Study ID Numbers: NRI 12-415
• First Posted: Mar 25, 2015
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: stroke; Injury, Brain, Traumatic; Family Caregivers; TBI (Traumatic Brain Injury); Informal Caregivers
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

Participant Flow

Recruitment Details	The number of recruited participants (143) is slightly different from the number of participants represented in the flow diagram (137) due to the fact there were 6 participants after recruitment and informed consent we were not able to reach them for data collection.
Pre-assignment Detail	Veterans and Caregiver were enrolled as dyads. "Participants" refers to the Dyads.

Arm/Group Title	ANSWERS-VA	Control
Arm/Group Description	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: 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 Traumatic Brain Injury (TBI).	8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Period Title: Overall Study
STARTED	69	68
COMPLETED	67	63
NOT COMPLETED	2	5

Baseline Characteristics

Arm/Group Title	ANSWERS-VA	Control	Total
Arm/Group Description	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: 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.	8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager	Total of all reporting groups
Overall Participants	67	63	130
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	57 85.1%	50 79.4%	107 82.3%
>=65 years	10 14.9%	13 20.6%	23 17.7%
Sex: Female, Male (Count of Participants)
Female	61 91%	57 90.5%	118 90.8%
Male	6 9%	6 9.5%	12 9.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale
Description	Depression scores are measured with the PHQ9 scale. Scores can range from 0 to 27, with higher scores indicating higher levels of depression.
Time Frame	Baseline, Week 12, 6 months and 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ANSWERS-VA	Control
Arm/Group Description	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: 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.	8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Measure Participants	66	62
Baseline	.56 (.53)	.68 (.61)
Week 12	.41 (.45)	.62 (.59)
6 Months	.20 (.25)	.57 (.56)
1 Year	.47 (.66)	.43 (.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	12 weeks compared to Baseline (BL)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.8407
	Comments	Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.016
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .117
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	At 6 months compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.0150
	Comments	Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.201
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .120
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	1 year compared BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.8373
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.114
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .188
	Estimation Comments

2. Primary Outcome

Title	Mediators of Caregiver's Task Difficulty
Description	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.
Time Frame	Baseline, Week 12, 6 months and 1 year

Outcome Measure Data

Analysis Population Description

Not change data

Arm/Group Title	ANSWERS-VA	Control
Arm/Group Description	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: 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.	8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Measure Participants	67	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	12 weeks compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.6445
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.016
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .173
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	6 months compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.5247
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.033
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .158
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	1 year compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.9974
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.1224
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .187
	Estimation Comments

3. Primary Outcome

Title	Mediators of Caregiver's Optimism Scale
Description	Optimism is measured with the Life Orientation Test-Revised Scale. Scores can range from 0 to 40 with higher scores indicating more optimism.
Time Frame	Baseline, Week 12, 6 months and 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ANSWERS-VA	Control
Arm/Group Description	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: 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.	8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Measure Participants	67	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	12 weeks compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.1918
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.054
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .087
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	6 months compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.9212
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.046
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .078
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	1 year compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.2358
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.026
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .083
	Estimation Comments

4. Primary Outcome

Title	Mediators of Caregiver's Threat Appraisal Scale
Description	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.
Time Frame	Baseline, Week 12, 6 months and 1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ANSWERS-VA	Control
Arm/Group Description	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: 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.	8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Measure Participants	67	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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	12 weeks compared to BL
	Type of Statistical Test	Superiority
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
Statistical Test of Hypothesis	p-Value	.1107
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.008
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .168
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	6 months compared to BL
	Type of Statistical Test	Superiority
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
Statistical Test of Hypothesis	p-Value	.0562
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.251
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .211
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ANSWERS-VA
	Comments	1 year compared to BL
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.8579
	Comments	adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	.226
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .218
	Estimation Comments

Adverse Events

Time Frame	Baseline to 12 month follow up.
Arm/Group Title	ANSWERS-VA		Control
Arm/Group Description	8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths: 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.		8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
All Cause Mortality
	ANSWERS-VA		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/63 (0%)
Serious Adverse Events
	ANSWERS-VA		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	ANSWERS-VA		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/67 (3%)		0/63 (0%)
Cardiac disorders
Adverse Event	1/67 (1.5%)	1	0/63 (0%)	0
adverse event	1/67 (1.5%)	1	0/63 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.