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Optimizing Dementia Care (ODeC)

Primary Purpose

Alzheimer's Disease, Dementia, Dementia, Vascular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling (C)
Care Consultation (CC)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Behavioral sciences, Counseling, Intervention Studies, Cognitive Behavioral Therapy, Telemedicine, Mindfulness

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Veterans:

  • Must be age 19 or older
  • Must have a diagnosis of dementia or a related disorder
  • Must live in the community (i.e. not in a VA Community Living Center, nursing home, or other facility)
  • Must cohabitate with a caregiver
  • Must have reliable access to a telephone
  • Must be willing to consent to participate or provide assent in conjunction with proxy consent if their decision-making capacity is compromised

Caregivers:

  • Must be age 19 or older
  • Must self-identify as assisting with care for at least 8 hours/week
  • Must be willing to consent to participate

Exclusion Criteria:

Veterans:

  • Currently incarcerated
  • Currently pregnant
  • Dyads experiencing low levels of distress

Caregivers:

  • Currently incarcerated
  • Currently pregnant
  • Experiencing severe cognitive impairment that would impair their ability to communicate during an interview
  • Dyads experiencing low levels of distress

Sites / Locations

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Care Consultation (CC)

Care Consultation + Counseling (CC+C)

Arm Description

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" - much like an interview guide - which then immediately shapes development of concrete action plans.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory
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.
Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale
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).
Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure
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.
Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia
Depression symptoms measure, scores range from 0 to 38 with higher scores indicating more depressive symptoms as rated by their caregiver.

Secondary Outcome Measures

Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months
Number and percentage of Veterans with dementia in long-term care facilities as reported by the caregivers at 12 months.

Full Information

First Posted
October 14, 2015
Last Updated
December 13, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02585232
Brief Title
Optimizing Dementia Care
Acronym
ODeC
Official Title
Optimizing Dementia Care Through Collaborative Recovery Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
October 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this randomized controlled pilot study is to examine the preliminary effectiveness, feasibility, and potential treatment moderators (i.e., behavioral symptoms and spousal relationship status) of a newly developed intervention for individuals with dementia and their family caregivers that combines elements of the established care consultation (CC) approach with additional counseling modules (CC+C). Outcomes for Veterans with dementia and their family caregivers (e.g., depressive symptoms, care-related burden, quality of life, pleasant events, etc.) will be assessed after 6 months of treatment and again at 12 months.
Detailed Description
Background: Dementia affects over 7% of Veterans age 65 and above seeking care through the Veteran's Health Administration (VHA), amounting to one out of every eleven Veterans in some VISNs. The unique functional and behavioral impairments associated with Alzheimer's or a related dementia (ADRD) contribute substantially to psychological and physical morbidity of family caregivers and high rates of nursing home placement, with 60% of ADRD caregivers rating the emotional stress of caregiving as "high or very high," and over one third reporting depressive symptoms. Although numerous evidence-based interventions have been developed to reduce caregiver burden and improve mental health and functional outcomes of the person with dementia, a recent systematic review noted almost none of these interventions "make it off of the shelf" to be readily available in clinical settings. Care Consultation (CC) has emerged as a rare exception. CC is an evidence-based telephone intervention delivering psychoeducation, care coordination, and resource referrals in diverse areas such as safety and mental and behavioral health support. Yet CC's focus on coaching and support is inadequate for dyads experiencing high levels of distress. A stepped-intervention approach would address the VA's efficiency needs while allowing the flexibility for more resource-intensive additional counseling beyond the established CC framework when warranted by high dyad distress. This CDA-2 proposal would move such a dyadic intervention forward. Objectives: 1) Manualize the integration of care consultation and counseling components (i.e., the CC+C intervention). CC+C is guided by a rehabilitation recovery-based conceptual model to address the most common high distress targets (e.g., relationship distress, Veteran or caregiver depression, anxiety, or pain) using patient-centered approaches. 2) Evaluate preliminary effectiveness and feasibility of the CC+C Intervention in a randomized controlled pilot study of distressed dyads to compare: a) the established CC intervention, to b) the CC+C intervention on Veteran and caregiver outcomes. 3) Conduct exploratory analyses of the CC+C intervention on Veteran long-term care placement at six and 12 months and examine two key treatment moderators (behavioral symptoms and spousal relationship status) that may impact intervention engagement and response to treatment. The investigators hypothesize that: 1) Caregivers assigned to CC+C will have greater reductions in caregiver burden at 6 months than those assigned to CC alone. 2) Indicators of relationship strain (i.e., marital distress and/or mutuality) will show greater improvement in CC+C than CC at 6 months. 3) Gains in shared pleasant events, social engagement, and quality of life will be greater in CC+C than in CC alone at 6 months. 4) Participants with dementia in both groups will have reduced depressive symptoms at 6 months. The investigators will also explore the impact of the two interventions on rates of placement in long-term care facilities (such as nursing homes, VA Community Living Centers or other supportive living environments) at 6 and 12 months. Methods: Ten modules combining successful elements from existing manualized therapies and exercises developed by the investigative team during the CDA1 period will be integrated with CC into a draft CC+C intervention manual. The manual will be finalized with input from the mentoring team and an Expert Advisory Panel for completeness, feasibility, and safety and risk considerations. Next 68 distressed Veterans with dementia and their family caregivers will be recruited and randomized to either the CC+C intervention group or the CC comparison group. Patient, caregiver, and relationship outcomes (e.g., burden, depressive symptoms, anxiety, quality of life, relationship distress) will be measured at baseline, 6 months, and 12 months. Treatment implementation and feasibility data will be collected. Anticipated Impacts: The goal of this career development study is to acquire the knowledge, skills and experience necessary to successfully compete for an RR&D Merit Review Award evaluating a randomized controlled trial powered to establish efficacy and test effectiveness of the CC+C intervention. Rehabilitation-focused interventions that maximize functioning are essential for successful non-institutional VA dementia care in the future. Work completed during the CDA2 period will serve as a foundation for a career committed to this goal. The impact of this work will be realized when an efficacious and highly-accessible intervention, such as the telephone-based dyadic intervention being piloted, becomes available for aging Veterans and their families.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia, Dementia, Vascular, Caregivers, Veterans
Keywords
Behavioral sciences, Counseling, Intervention Studies, Cognitive Behavioral Therapy, Telemedicine, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care Consultation (CC)
Arm Type
Active Comparator
Arm Description
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" - much like an interview guide - which then immediately shapes development of concrete action plans.
Arm Title
Care Consultation + Counseling (CC+C)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counseling (C)
Intervention Description
The counseling component incorporates elements of existing manualized interventions that have been 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.).
Intervention Type
Behavioral
Intervention Name(s)
Care Consultation (CC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory
Description
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.
Time Frame
Baseline, 6 months
Title
Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale
Description
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).
Time Frame
Baseline, 6 months
Title
Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure
Description
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.
Time Frame
Baseline, 6 months
Title
Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia
Description
Depression symptoms measure, scores range from 0 to 38 with higher scores indicating more depressive symptoms as rated by their caregiver.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months
Description
Number and percentage of Veterans with dementia in long-term care facilities as reported by the caregivers at 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans: Must be age 19 or older Must have a diagnosis of dementia or a related disorder Must live in the community (i.e. not in a VA Community Living Center, nursing home, or other facility) Must cohabitate with a caregiver Must have reliable access to a telephone Must be willing to consent to participate or provide assent in conjunction with proxy consent if their decision-making capacity is compromised Caregivers: Must be age 19 or older Must self-identify as assisting with care for at least 8 hours/week Must be willing to consent to participate Exclusion Criteria: Veterans: Currently incarcerated Currently pregnant Dyads experiencing low levels of distress Caregivers: Currently incarcerated Currently pregnant Experiencing severe cognitive impairment that would impair their ability to communicate during an interview Dyads experiencing low levels of distress
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle M Hilgeman, PhD
Organizational Affiliation
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuscaloosa VA Medical Center, Tuscaloosa, AL
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21242317
Citation
Judge KS, Bass DM, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy C, Kunik ME. Partners in dementia care: a care coordination intervention for individuals with dementia and their family caregivers. Gerontologist. 2011 Apr;51(2):261-72. doi: 10.1093/geront/gnq097. Epub 2011 Jan 17.
Results Reference
background
PubMed Identifier
23869899
Citation
Bass DM, Judge KS, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy CA, Maslow K, Moye JA, Randazzo R, Garcia-Maldonado M, Elbein R, Odenheimer G, Kunik ME. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013 Aug;61(8):1377-86. doi: 10.1111/jgs.12362. Epub 2013 Jul 19.
Results Reference
background
PubMed Identifier
24764496
Citation
Bass DM, Judge KS, Snow AL, Wilson NL, Morgan RO, Maslow K, Randazzo R, Moye JA, Odenheimer GL, Archambault E, Elbein R, Pirraglia P, Teasdale TA, McCarthy CA, Looman WJ, Kunik ME. A controlled trial of Partners in Dementia Care: veteran outcomes after six and twelve months. Alzheimers Res Ther. 2014 Feb 28;6(1):9. doi: 10.1186/alzrt242. eCollection 2014.
Results Reference
background
PubMed Identifier
12604748
Citation
Bass DM, Clark PA, Looman WJ, McCarthy CA, Eckert S. The Cleveland Alzheimer's managed care demonstration: outcomes after 12 months of implementation. Gerontologist. 2003 Feb;43(1):73-85. doi: 10.1093/geront/43.1.73.
Results Reference
background

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Optimizing Dementia Care

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