Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANSWERS-VA | Experimental | 8 week telephone intervention with nurse case manager using "Acquiring New Skills While Enhancing Remaining Strengths" (ANSWERS) |
|
| Control | Other | 8 week telephone usual care with education with nurse case manager |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Virginia (Ginger) S. Wilder, PhD MSN RN | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34813082 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Veterans and Caregiver were enrolled as dyads. "Participants" refers to the Dyads.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ANSWERS-VA | 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). |
| FG001 | Control | 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ANSWERS-VA | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Not change data. One Intervention Caregiver and one Control Caregiver did not complete the PHQ9. Those data are missing. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, 6 months and 1 year |
|
Baseline to 12 month follow up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANSWERS-VA | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event | Cardiac disorders | Systematic Assessment | Participant presented to local Emergency Department with chest pains. Diagnosed with A-fib, released to home and told to follow up with Primary Care Physician. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Virginia (Daggett) Wilder | VHA | 307-675-3659 | virginia.wilder@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2015 | Jan 1, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2016 | Jan 1, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control | Other | 8 week telephone usual care with education with nurse case manager |
|
| Michael E. DeBakey VA Medical Center, Houston, TX |
| Houston |
| Texas |
| 77030 |
| United States |
| BG001 | Control | 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Control | 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager |
|
|
|
| Primary | 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. | Not change data | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, 6 months and 1 year |
|
|
|
|
| Primary | 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. | Not change data. One Control Caregiver did not complete the Life Orientation Test-Revised Scale. Those data are missing. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, 6 months and 1 year |
|
|
|
|
| Primary | 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. | Not change data. One Control Caregivers did not complete the Threat Subscale. Those data are missing. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12, 6 months and 1 year |
|
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 2 |
| 67 |
| EG001 | Control | 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager | 0 | 63 | 0 | 63 | 0 | 63 |
|
| adverse event | Cardiac disorders | Systematic Assessment | Participant reported she had a minor heart attack in September. This was reported to research personnel at an outcomes calls. Hospitalized overnight at local hospital and released to home. |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| 12 Week |
|
|
| 6 Months |
|
|
| 1 Year |
|
|
6 months compared to BL
| Mixed Models Analysis |
| .5247 |
adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression |
| Median Difference (Net) |
| .033 |
| Standard Error of the Mean |
| .158 |
| 2-Sided |
| Superiority |
| 1 year compared to BL | Mixed Models Analysis | .9974 | adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression | Median Difference (Net) | .1224 | Standard Error of the Mean | .187 | 2-Sided | Superiority |
| 12 Week |
|
|
| 6 Months |
|
|
| 1 Year |
|
|
6 months compared to BL
| Mixed Models Analysis |
| .9212 |
adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression |
| Median Difference (Net) |
| .046 |
| Standard Error of the Mean |
| .078 |
| 2-Sided |
| Superiority |
| 1 year compared to BL | Mixed Models Analysis | .2358 | adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression | Median Difference (Net) | .026 | Standard Error of the Mean | .083 | 2-Sided | Superiority |
| 12 Week |
|
|
| 6 Months |
|
|
| 1 Year |
|
|
6 months compared to BL
| Mixed Models Analysis |
| .0562 |
| Median Difference (Net) |
| .251 |
| Standard Error of the Mean |
| .211 |
| 2-Sided |
| Superiority |
adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression |
| 1 year compared to BL | Mixed Models Analysis | .8579 | adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression | Median Difference (Net) | .226 | Standard Error of the Mean | .218 | 2-Sided | Superiority |