Trial Outcomes & Findings for Informal Caregivers ANSWERS-VA (NCT NCT02398409)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

143 participants

Primary outcome timeframe

Baseline, Week 12, 6 months and 1 year

Results posted on

2020-06-17

Participant Flow

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.

Veterans and Caregiver were enrolled as dyads. "Participants" refers to the Dyads.

Participant milestones

Participant milestones
Measure	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).	Control 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Overall Study STARTED	69	68
Overall Study COMPLETED	67	63
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ANSWERS-VA n=67 Participants 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.	Control n=63 Participants 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=67 Participants	0 Participants n=63 Participants	0 Participants n=130 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=67 Participants	50 Participants n=63 Participants	107 Participants n=130 Participants
Age, Categorical >=65 years	10 Participants n=67 Participants	13 Participants n=63 Participants	23 Participants n=130 Participants
Sex: Female, Male Female	61 Participants n=67 Participants	57 Participants n=63 Participants	118 Participants n=130 Participants
Sex: Female, Male Male	6 Participants n=67 Participants	6 Participants n=63 Participants	12 Participants n=130 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline, Week 12, 6 months and 1 year

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

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

Outcome measures

Outcome measures
Measure	ANSWERS-VA n=66 Participants 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.	Control n=62 Participants 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale Baseline	.56 score on a scale Standard Deviation .53	.68 score on a scale Standard Deviation .61
Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale Week 12	.41 score on a scale Standard Deviation .45	.62 score on a scale Standard Deviation .59
Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale 6 Months	.20 score on a scale Standard Deviation .25	.57 score on a scale Standard Deviation .56
Caregiver's Depressive Symptoms by Patient Health Questionnaire (PHQ9) Scale 1 Year	.47 score on a scale Standard Deviation .66	.43 score on a scale Standard Deviation .49

PRIMARY outcome

Timeframe: Baseline, Week 12, 6 months and 1 year

Population: Not change data

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.

Outcome measures

Outcome measures
Measure	ANSWERS-VA n=67 Participants 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.	Control n=63 Participants 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Mediators of Caregiver's Task Difficulty Baseline	1.99 score on a scale Standard Deviation .77	1.83 score on a scale Standard Deviation .68
Mediators of Caregiver's Task Difficulty 12 Week	1.73 score on a scale Standard Deviation .70	1.73 score on a scale Standard Deviation .61
Mediators of Caregiver's Task Difficulty 6 Months	1.70 score on a scale Standard Deviation .64	1.63 score on a scale Standard Deviation .57
Mediators of Caregiver's Task Difficulty 1 Year	1.78 score on a scale Standard Deviation .62	1.66 score on a scale Standard Deviation .79

PRIMARY outcome

Timeframe: Baseline, Week 12, 6 months and 1 year

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

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

Outcome measures

Outcome measures
Measure	ANSWERS-VA n=67 Participants 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.	Control n=62 Participants 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Mediators of Caregiver's Optimism Scale Baseline	2.29 score on a scale Standard Deviation .35	2.33 score on a scale Standard Deviation .39
Mediators of Caregiver's Optimism Scale 12 Week	2.19 score on a scale Standard Deviation .40	2.29 score on a scale Standard Deviation .27
Mediators of Caregiver's Optimism Scale 6 Months	2.31 score on a scale Standard Deviation .34	2.29 score on a scale Standard Deviation .31
Mediators of Caregiver's Optimism Scale 1 Year	2.25 score on a scale Standard Deviation .27	2.28 score on a scale Standard Deviation .37

PRIMARY outcome

Timeframe: Baseline, Week 12, 6 months and 1 year

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

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.

Outcome measures

Outcome measures
Measure	ANSWERS-VA n=67 Participants 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.	Control n=62 Participants 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Mediators of Caregiver's Threat Appraisal Scale Baseline	2.73 score on a scale Standard Deviation .86	2.66 score on a scale Standard Deviation .78
Mediators of Caregiver's Threat Appraisal Scale 12 Week	2.56 score on a scale Standard Deviation .83	2.49 score on a scale Standard Deviation .68
Mediators of Caregiver's Threat Appraisal Scale 6 Months	2.38 score on a scale Standard Deviation .95	2.69 score on a scale Standard Deviation .67
Mediators of Caregiver's Threat Appraisal Scale 1 Year	2.58 score on a scale Standard Deviation 1.0	2.44 score on a scale Standard Deviation .61

Adverse Events

ANSWERS-VA

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ANSWERS-VA n=67 participants at risk 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.	Control n=63 participants at risk 8 week telephone usual care with education with nurse case manager Control: 8 week telephone usual care with education with nurse case manager
Cardiac disorders Adverse Event	1.5% 1/67 • Number of events 1 • Baseline to 12 month follow up.	0.00% 0/63 • Baseline to 12 month follow up.
Cardiac disorders adverse event	1.5% 1/67 • Number of events 1 • Baseline to 12 month follow up.	0.00% 0/63 • Baseline to 12 month follow up.

Additional Information

Dr. Virginia (Daggett) Wilder

VHA

Phone: 307-675-3659

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place