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Optimizing Dementia Care (ODeC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585232
Recruitment Status : Completed
First Posted : October 23, 2015
Results First Posted : September 13, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Dementia, Vascular Caregivers Veterans Behavioral: Counseling (C) Behavioral: Care Consultation (CC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Dementia Care Through Collaborative Recovery Interventions
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : August 5, 2020
Actual Study Completion Date : October 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Active Comparator: 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" - much like an interview guide - which then immediately shapes development of concrete action plans.
Behavioral: 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.

Experimental: 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.
Behavioral: Counseling (C)
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.).

Behavioral: 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.




Primary Outcome Measures :
  1. Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory [ Time Frame: Baseline, 6 months ]
    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.

  2. Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale [ Time Frame: Baseline, 6 months ]
    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).

  3. Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure [ Time Frame: 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.

  4. Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia [ Time Frame: Baseline, 6 months ]
    Depression symptoms measure, scores range from 0 to 38 with higher scores indicating more depressive symptoms as rated by their caregiver.


Secondary Outcome Measures :
  1. Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months [ Time Frame: 12 months ]
    Number and percentage of Veterans with dementia in long-term care facilities as reported by the caregivers at 12 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585232


Locations
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United States, Alabama
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Michelle M Hilgeman, PhD Tuscaloosa VA Medical Center, Tuscaloosa, AL
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02585232    
Other Study ID Numbers: D1824-W
First Posted: October 23, 2015    Key Record Dates
Results First Posted: September 13, 2021
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Behavioral sciences
Counseling
Intervention Studies
Cognitive Behavioral Therapy
Telemedicine
Mindfulness
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases