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Alzheimer's DiseaseODeCNCT02585232

Optimizing Dementia Care

A study testing Counseling (C) and Care Consultation (CC) in people with Alzheimer's Disease and Dementia, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Alzheimer's Disease, Dementia, Dementia, Vascular
What is being tested?
Counseling (C) and Care Consultation (CC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteUnited States
Study dates
1 Oct 2016to 22 Oct 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • Veterans:
  • Currently incarcerated
  • Currently pregnant
  • Dyads experiencing low levels of distress
  • Caregivers:
  • Currently incarcerated
Show all 9Show fewer
  • Currently pregnant
  • Experiencing severe cognitive impairment that would impair their ability to communicate during an interview
  • Dyads experiencing low levels of distress

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

    Tuscaloosa, Alabama, 35404

Other trials in United States

About this study

Official title: Optimizing Dementia Care Through Collaborative Recovery Interventions

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.

Read the 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.

Being tested
Counseling (C), Care Consultation (CC)
Keywords
Behavioral sciences, Counseling, Intervention Studies, Cognitive Behavioral Therapy, Telemedicine, Mindfulness
Medical subject headings
Alzheimer Disease, Dementia, Dementia, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Counseling (C)Behavioural

    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.).

  • Care Consultation (CC)Behavioural

    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.

Study groups in NCT02585232
Study groupRoleWhat they receive
Care Consultation (CC)Active comparatorCare 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.
Receives: Behavioral: Care Consultation (CC)
Care Consultation + Counseling (CC+C)ExperimentalCare 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.
Receives: Behavioral: Counseling (C); Behavioral: Care Consultation (CC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 6 months

  2. 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).

    Measured: Baseline, 6 months

  3. 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.

    Measured: Baseline, 6 months

  4. 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.

    Measured: Baseline, 6 months

Secondary outcomes (1)
  1. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion5 Aug 2020
  4. Study completion22 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585232
Sponsor's protocol ID
D1824-W
Acronym
ODeC
Status last verified
Dec 2021
First submitted
14 Oct 2015
Last updated
11 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21242317
  • 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.

    PubMed 23869899
  • 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.

    PubMed 24764496
  • 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.

    PubMed 12604748

Questions about this trial

What is this clinical trial studying?

A study testing Counseling (C) and Care Consultation (CC) in people with Alzheimer's Disease and Dementia, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory (time frame: Baseline, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585232, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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