Trial Outcomes & Findings for Optimizing Dementia Care (NCT NCT02585232)

Last Updated: 2022-01-11

Results Overview

The Zarit Caregiver Burden Inventory is a measure of strain related to providing care for someone with dementia. Scores range from 0 to 48 with higher scores indicating more caregiver burden.

Recruitment status

COMPLETED

Study phase

Target enrollment

86 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2022-01-11

Participant Flow

Veterans and caregivers were considered enrolled (N = 144 total participants), and are reported here as dyads. Enrollment numbers in this section refers to dyads/ caregivers. (Veteran participants with dementia were not enrolled without a caregiver, but a caregiver could be enrolled without a participating person with dementia.) N = 4 caregivers were enrolled (completed informed consent) but did not complete baseline assessment and therefore were not randomized to group.

Participant milestones

Participant milestones
Measure	Care Consultation (CC) Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Overall Study STARTED	40	42
Overall Study COMPLETED	28	26
Overall Study NOT COMPLETED	12	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Care Consultation (CC) Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Overall Study Lost to Follow-up	8	8
Overall Study Withdrawal by Subject	4	8

Baseline Characteristics

Optimizing Dementia Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Care Consultation (CC) n=40 Participants Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=42 Participants Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).	Total n=82 Participants Total of all reporting groups
Age, Continuous	65.34 years n=5 Participants	64.68 years n=7 Participants	65.00 years n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	40 Participants n=5 Participants	42 Participants n=7 Participants	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: Statistics control for covariates that were different between the two groups at baseline (i.e., Montreal Cognitive Assessment, MoCA, and education); analyses are based on all cases with valid data for all variables in the model. Number of participants in this section refers to caregivers.

The Zarit Caregiver Burden Inventory is a measure of strain related to providing care for someone with dementia. Scores range from 0 to 48 with higher scores indicating more caregiver burden.

Outcome measures

Outcome measures
Measure	Care Consultation (CC) n=21 Participants Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=18 Participants Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory	-2.38 change units on a scale Standard Deviation 6.77	0.22 change units on a scale Standard Deviation 5.26

PRIMARY outcome

Timeframe: Baseline, 6 months

Population: Number of participants refers to number of spousal caregivers/ caregivers in a romantic relationship with the Veteran/ person with dementia.

Relationship satisfaction and cohesion measure for spouses and partners in a romantic relationship. Scores range from 0 to 151, and higher scores indicate higher levels of relationship satisfaction. Not all caregivers were in a romantic relationship with the person with dementia, this scale was only administered to dyads who were married or partnered (e.g., adult children caregivers would not have received this measure).

Outcome measures

Outcome measures
Measure	Care Consultation (CC) n=9 Participants Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=11 Participants Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale	6.44 change units on a scale Standard Deviation 21.45	-2.64 change units on a scale Standard Deviation 18.72

PRIMARY outcome

Timeframe: Baseline, 6 months

Change in shared pleasant events, social engagement, and quality of life is hypothesized to be greater in caregivers assigned to CC+C than in CC alone at 6 months. Scores range from 19 to 95, and higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Care Consultation (CC) n=17 Participants Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=15 Participants Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure	.59 change units on a scale Standard Deviation 5.34	-2.97 change units on a scale Standard Deviation 3.74

PRIMARY outcome

Timeframe: Baseline, 6 months

Depression symptoms measure, scores range from 0 to 38 with higher scores indicating more depressive symptoms as rated by their caregiver.

Outcome measures

Outcome measures
Measure	Care Consultation (CC) n=9 Participants Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=10 Participants Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia	-2.000 change in units on a scale Standard Deviation 5.172	-1.100 change in units on a scale Standard Deviation 6.740

SECONDARY outcome

Timeframe: 12 months

Population: Number of participants in this outcome measure refers to the number of Veterans with dementia in long term care (as reported by the caregivers).

Number and percentage of Veterans with dementia in long-term care facilities as reported by the caregivers at 12 months.

Outcome measures

Outcome measures
Measure	Care Consultation (CC) n=28 Participants Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=26 Participants Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months	3 Participants	3 Participants

Adverse Events

Care Consultation (CC)

Serious events: 11 serious events

Other events: 1 other events

Deaths: 3 deaths

Care Consultation + Counseling (CC+C)

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Care Consultation (CC) n=72 participants at risk Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=72 participants at risk Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Surgical and medical procedures Hospitalizations and Emergency Room Visits	13.9% 10/72 • Number of events 10 • 1 year Adverse events include: hospitalizations, emergency room visits, and one participant who had a house fire during the 12-month study period. Reporting of adverse events is based on all caregivers (n = 82) and veterans (n = 62) that were enrolled and randomized; the caregivers and veterans in each group were n = 72 for CC and n = 72 for CC+C, for a total of N = 144 participants.	13.9% 10/72 • Number of events 10 • 1 year Adverse events include: hospitalizations, emergency room visits, and one participant who had a house fire during the 12-month study period. Reporting of adverse events is based on all caregivers (n = 82) and veterans (n = 62) that were enrolled and randomized; the caregivers and veterans in each group were n = 72 for CC and n = 72 for CC+C, for a total of N = 144 participants.
Social circumstances House fire	1.4% 1/72 • Number of events 1 • 1 year Adverse events include: hospitalizations, emergency room visits, and one participant who had a house fire during the 12-month study period. Reporting of adverse events is based on all caregivers (n = 82) and veterans (n = 62) that were enrolled and randomized; the caregivers and veterans in each group were n = 72 for CC and n = 72 for CC+C, for a total of N = 144 participants.	0.00% 0/72 • 1 year Adverse events include: hospitalizations, emergency room visits, and one participant who had a house fire during the 12-month study period. Reporting of adverse events is based on all caregivers (n = 82) and veterans (n = 62) that were enrolled and randomized; the caregivers and veterans in each group were n = 72 for CC and n = 72 for CC+C, for a total of N = 144 participants.

Other adverse events

Other adverse events
Measure	Care Consultation (CC) n=72 participants at risk Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment" - much like an interview guide - which then immediately shapes development of concrete action plans. Care Consultation (CC): Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the "initial assessment," which then immediately shapes development of concrete action plans.	Care Consultation + Counseling (CC+C) n=72 participants at risk Care Consultation + Counseling (CC+C): is consistent with the original CC protocol in that the therapist partners with each dyad in a patient-centered way to prioritize unmet needs as identified during the CC initial assessment. Once this phase has been completed, typically within the first 2 sessions, the CC+C therapist will determine when to initiate counseling sessions targeting 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.). The counseling component of the CC+C intervention incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling (C): The counseling component is tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
Social circumstances Duplicate measures collected	1.4% 1/72 • Number of events 1 • 1 year Adverse events include: hospitalizations, emergency room visits, and one participant who had a house fire during the 12-month study period. Reporting of adverse events is based on all caregivers (n = 82) and veterans (n = 62) that were enrolled and randomized; the caregivers and veterans in each group were n = 72 for CC and n = 72 for CC+C, for a total of N = 144 participants.	0.00% 0/72 • 1 year Adverse events include: hospitalizations, emergency room visits, and one participant who had a house fire during the 12-month study period. Reporting of adverse events is based on all caregivers (n = 82) and veterans (n = 62) that were enrolled and randomized; the caregivers and veterans in each group were n = 72 for CC and n = 72 for CC+C, for a total of N = 144 participants.

Additional Information

Dr. Michelle Hilgeman

Tuscaloosa VA Medical Center

Phone: 205-554-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place